A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!


Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
Course #: BI14136
December 7, 2020 | Interactive Web Seminar
2:30 PM - 4:00 PM Eastern
$735.00


NEW! 30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols
Course #: BI14220
December 7, 2020 - February 15, 2021 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern
$1,995.00


Introduction to Statistics for Non-Statisticians
Course #: BI14138
December 8, 2020 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


NEW! 12-Hour Clinical Trial Management Series
Course #: BI14223
December 8, 2020 - January 19, 2021 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern
$1,795.00


30-Hour Clinical Project Management Fundamentals Certification Program
Course #: BI14543
December 9, 2020 - February 24, 2021 | Interactive Web Seminar
10:00 AM - 1:00 PM Eastern
$1,995.00


Final ICH GCP E6 R2: Impact on Clinical Data Management
Course #: BI14140
December 10, 2020 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
Course #: BI14141
December 10, 2020 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$835.00


NEW! Strategies for Remote Auditing of Investigative Sites
Course #: BI14215
December 14-21, 2020 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$1,195.00


Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
Course #: BI14144
December 14, 2020 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


10-Week CRA & CRC Beginner Program
Course #: BI14544
December 14, 2020 - March 1, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
$1,995.00


Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
Course #: BI14145
December 14, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Cases in Advanced GCP: A Problem-Solving Practicum
Course #: BI14148
December 15, 2020 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Final Guidance
Course #: BI14146
December 15, 2020 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Ensuring Success Through Smarter Site Selection and Study Feasibility
Course #: BI14149
December 15, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs
Course #: BI14147
December 15, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Use of Electronic Health Record Data in Clinical Investigations
Course #: BI14151
December 16, 2020 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Root Cause Analysis: Applying the Concept for Better Study Compliance Management
Course #: BI14150
December 16, 2020 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$625.00


Clinical Research Financial Management for Investigative Sites
Course #: BI14152
December 16, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Course #: BI14154
December 17, 2020 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
Course #: BI14153
December 17, 2020 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$625.00


Managing Phase I Clinical Trials
Course #: BI14155
December 17, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Course #: BI14156
December 18, 2020 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$835.00


Monitoring Reports: 10 Rules of Effective Report Writing
Course #: BI14158
December 21, 2020 | Interactive Web Seminar
12:30 PM - 3:30 PM Eastern
$835.00


NEW! Strategies for Effective Remote Monitoring
Course #: BI14236
December 21, 2020 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation
Course #: BI14159
December 22, 2020 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Adverse Event Monitoring for CRAs
Course #: BI14160
January 4, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$735.00


Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
Course #: BI14161
January 5, 2021 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$835.00


Writing the Clinical Study Report
Course #: BI14162
January 6, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$735.00


Managing CRAs to Improve Performance and Study Outcomes
Course #: BI14163
January 7, 2021 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$625.00


Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance
Course #: BI14165
January 8, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$835.00


Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Course #: BI14166
January 8, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


State Laws Governing Clinical Trial Regulatory Compliance
Course #: BI14164
January 8, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


The Fundamentals of Clinical Research Project Management
Course #: BI14168
January 11, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Essential Documentation in Clinical Trials at Research Sites
Course #: BI14167
January 11, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Preparing Clinical Research Sites for FDA Inspections
Course #: BI14169
January 12, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$625.00


Monitoring Oncology Clinical Trials
Course #: BI14170
January 12, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Writing Clinical Study Protocols
Course #: BI14171
January 13, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


NEW! Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management
Course #: BI14205
January 13, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


NEW! ICH E8 (R1): Designing Quality into Clinical Studies
Course #: BI14242
January 14, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Preparation, Management, and Response to Inspections and Audits
Course #: BI14172
January 14, 2021 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$1,045.00


NEW! ICH E8 (R1): Changes Impacting Sponsors/CROs
Course #: BI14240
January 14, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
Course #: BI14173
January 15, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$835.00


20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research
Course #: BI14005
January 18 - February 22, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
Register by December 18 for only $1,695.00


Source Documentation: What is Adequate and Accurate?
Course #: BI14174
January 18, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Risk-Based Site Monitoring
Course #: BI14175
January 19, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Introduction to Data Management
Course #: BI14177
January 20, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Sponsor Responsibilities for Global Drug Studies
Course #: BI14176
January 20, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Monitoring Visit Reports for Medical Device Studies
Course #: BI14178
January 21, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


10-Week Clinical Research Coordinator (CRC) On-Boarding Program
Course #: BI14507
January 22 - April 2, 2021 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern
Register by December 18 for only $1,795.00


Coaching Skills for Leaders
Course #: BI14196
January 22, 2021 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$735.00


10-Week Clinical Research Associate (CRA) On-Boarding Program
Course #: BI14503
January 22 - April 2, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
Register by December 18 for only $1,795.00


Strategies for Having Difficult Conversations
Course #: BI14197
January 22, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs
Course #: BI14179
January 25, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$625.00


A Systematic Approach to Study Start-Up: Improving Site Activation
Course #: BI14180
January 25, 2021 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$735.00


FDA Requirements for Electronic Source Data in Clinical Investigations
Course #: BI14181
January 26, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Subject Recruitment: Proactive Project Plans and Issues Management
Course #: BI14182
January 26, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$625.00


Investigator Initiated Trials: Roles and Responsibilities
Course #: BI14184
January 27, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Auditing Techniques: A Problem-Solving Practicum
Course #: BI14183
January 27, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


The Revised HHS Common Rule: What You Need to Know Now
Course #: BI14185
January 27, 2021 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$835.00


Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
Course #: BI14187
January 28, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


Use of Notes to File in Clinical Trial Essential Documentation
Course #: BI14186
January 28, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$835.00


NEW! 10-Hour Clinical Trial Start-Up Series
Course #: BI14537
January 28 - February 25, 2021 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
Register by December 18 for only $1,595.00


NEW! 10-Hour Advanced Clinical Project Management Skills Development
Course #: BI14533
January 28 - February 25, 2021 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern
Register by December 18 for only $1,595.00


Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
Course #: BI14189
January 29, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
Course #: BI14188
January 29, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


NEW! Project Management of Phase I Oncology Trials
Course #: BI14263
February 1, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


The IND in a CTD/eCTD Format
Course #: BI14265
February 2, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Medical Writing Fundamentals: How to Write Regulatory Documents
Course #: BI14264
February 2, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


30-Hour Clinical Project Management Fundamentals Certification Program
Course #: BI14519
February 2 - April 27, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by January 8 for only $1,795.00


NEW! General Data Protection Regulation (GDPR): Developing a Compliant Data Privacy Program
Course #: BI14267
February 3, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$625.00


Strategies for Active Listening
Course #: BI14266
February 3, 2021 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$735.00


Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
Course #: BI14268
February 4, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
Course #: BI14270
February 8, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
Course #: BI14271
February 9, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$835.00


Case Report Form Design, Strategy, and Standards
Course #: BI14272
February 9, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Data Management Plan Creation: Content and Rationale
Course #: BI14273
February 9, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
Course #: BI14274
February 10, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Leading Teams in a Changing Clinical Research Environment
Course #: BI14276
February 10, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$735.00


Current FDA and EMA Inspection Findings: Lessons Learned
Course #: BI14275
February 10, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Sponsor Management of Investigator Non-Compliance
Course #: BI14277
February 11, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Monitoring Plan Development
Course #: BI14278
February 12, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
Course #: BI14279
February 15, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials
Course #: BI14280
February 15, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Building Relationships with Clinical Research Sites
Course #: BI14281
February 16, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


NEW! 10-Hour Clinical Research Manager Skills Development Series
Course #: BI14535
February 16 - March 16, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
Register by January 15 for only $1,595.00


Root Cause Analysis: Applying the Concept for Better Study Compliance Management
Course #: BI14282
February 16, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$625.00


The GCPs of Essential Documents
Course #: BI14283
February 16, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


10-Week CRA & CRC Beginner Program
Course #: BI14499
February 17 - May 5, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
Register by January 15 for only $1,795.00


ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
Course #: BI14284
February 17, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Course #: BI14286
February 17, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Risk-Based Auditing: Effective Compliance Strategies
Course #: BI14285
February 17, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Drug Development and FDA Regulations
Course #: BI14287
February 18, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$735.00


Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Course #: BI14288
February 18, 2021 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$735.00


NEW! 10-Week Fundamentals of Drug Development Series
Course #: BI14540
February 18 - April 22, 2021 | Interactive Web Seminar
3:00 PM - 6:00 PM Eastern
Register by January 15 for only $1,795.00


30-Hour Clinical Research Auditing Certification Program
Course #: BI14523
February 18 - April 29, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by January 15 for only $1,795.00


Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
Course #: BI14290
February 19, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$835.00


Introduction to Clinical Research
Course #: BI14291
February 19, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Establishing Quality Tolerance Limits
Course #: BI14289
February 19, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
Course #: BI14292
February 22, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$945.00


NEW! 30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols
Course #: BI14527
February 22 - May 3, 2021 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern
Register by January 22 for only $1,795.00


Monitoring Medical Device Trials: An Introduction
Course #: BI14293
February 23, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


10-Week Clinical Research Associate (CRA) On-Boarding Program
Course #: BI14504
February 23 - May 25, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by January 22 for only $1,795.00


Overseeing Teams and Projects
Course #: BI14294
February 24, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$835.00


CRO Partnership Management
Course #: BI14295
February 24, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Developing and Negotiating Research Site Clinical Study Budgets and Contracts
Course #: BI14296
February 25, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$835.00


Developing Clinical Study Budgets for Sponsors
Course #: BI14297
February 25, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Investigational Product Accountability Best Practices
Course #: BI14298
February 26, 2021 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$735.00


NEW! Strategies for Effective Remote Monitoring
Course #: BI14299
March 1, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


NEW! 12-Hour Clinical Trial Management Series
Course #: BI14529
March 1 - April 12, 2021 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern
Register by January 29 for only $1,595.00


A Systematic Approach to Study Start-Up: Improving Site Activation
Course #: BI14300
March 2, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Introduction to Statistics for Non-Statisticians
Course #: BI14302
March 2, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series
Course #: BI14510
March 2 - May 4, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$1,895.00


Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately
Course #: BI14301
March 2, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$625.00


ABCs of Clinical Research for Clinical Administrative Support Staff
Course #: BI14304
March 3, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$835.00


FDA Drug Approval Process
Course #: BI14303
March 3, 2021 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern
$735.00


ABCs of GCP and the 13 Principles of ICH GCP E6
Course #: BI14305
March 3, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program
Course #: BI14514
March 5 - May 7, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
Register by January 29 for only $1,695.00


Protocol Deviations: Documenting, Managing, and Reporting
Course #: BI14306
March 5, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual
Course #: BI14307
March 8, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
Course #: BI14308
March 8, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$625.00


Writing and Updating the Investigator's Brochure
Course #: BI14309
March 9, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Electronic Informed Consent Guidance: Regulatory Updates
Course #: BI14311
March 9, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Writing Clinical Study Protocols
Course #: BI14310
March 9, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


30-Hour Clinical Data Management On-Boarding Program
Course #: BI14517
March 10 - May 12, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
Register by February 5 for only $1,795.00


Good Clinical Practice: Practical Application and Implementation
Course #: BI14314
March 10, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
Course #: BI14313
March 10, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Ensuring Success Through Smarter Site Selection and Study Feasibility
Course #: BI14319
March 11, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Principal Investigator Oversight and the Appropriate Delegation of Tasks
Course #: BI14316
March 11, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Cases in Advanced GCP: A Problem-Solving Practicum
Course #: BI14318
March 11, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Final Guidance
Course #: BI14317
March 11, 2021 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$735.00


NEW! Strategies for Remote Auditing of Investigative Sites
Course #: BI14320
March 12-19, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$1,195.00


FDA Medical Device Approval Process
Course #: BI14321
March 12, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results
Course #: BI14322
March 15, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Course #: BI14324
March 16, 2021 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$735.00


Clinical Research Financial Management for Investigative Sites
Course #: BI14325
March 18, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Use of Electronic Health Record Data in Clinical Investigations
Course #: BI14315
March 18, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$835.00


eTMF Quality Oversight: A Risk-Based Approach
Course #: BI14326
March 19, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Regulatory Intelligence
Course #: BI14327
March 22, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


10-Week Clinical Research Financial Certification Program: Setting Up Compliant Financial Operations and Budgets
Course #: BI14509
March 22 - June 7, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
Register by February 19 for only $1,795.00


Good Laboratory Practice for Non-Clinical Studies
Course #: BI14328
March 23-25, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$1,045.00


NEW! 10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval
Course #: BI14531
March 23 - May 25, 2021 | Interactive Web Seminar
3:00 PM - 6:00 PM Eastern
Register by February 19 for only $1,795.00


Data Quality in Clinical Trials: Rationale and Impact
Course #: BI14329
March 24, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Risk-Based Quality and Compliance Management in Combination Product Trials
Course #: BI14330
March 25, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Risk-Based Monitoring: The Data Management Connection
Course #: BI14331
March 26, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
Course #: BI14332
March 29, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Informed Consent Procedure: Lessons Learned from Inspection Findings
Course #: BI14333
March 30, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
Course #: BI14334
March 30, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation
Course #: BI14336
March 31, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research
Course #: BI14512
March 31 - May 5, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
Register by February 26 for only $1,695.00


Incorporating Denials Management into Clinical Research Billing
Course #: BI14335
March 31, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


10-Week CRA & CRC Beginner Program
Course #: BI14500
March 31 - June 16, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by February 26 for only $1,795.00


Managing CRAs to Improve Performance and Study Outcomes
Course #: BI14337
April 1, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$625.00


NEW! 10-Week Conducting and Managing Oncology Clinical Trials
Course #: BI14539
April 1 - June 3, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
Register by February 26 for only $1,795.00


Monitoring Visit Reports for Medical Device Studies
Course #: BI14338
April 2, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Managing Phase I Clinical Trials
Course #: BI14339
April 5, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


NEW! Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management
Course #: BI14340
April 5, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Coaching Skills for Leaders
Course #: BI14341
April 5, 2021 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$735.00


Writing the Clinical Study Report
Course #: BI14342
April 6, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$735.00


Source Documentation: What is Adequate and Accurate?
Course #: BI14344
April 7, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Introduction to Data Management
Course #: BI14343
April 7, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
Course #: BI14345
April 8, 2021 | Interactive Web Seminar
8:30 AM - 11:00 AM Eastern
$835.00


Preparing Clinical Research Sites for FDA Inspections
Course #: BI14346
April 8, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$625.00


30-Hour Clinical Project Management Fundamentals Certification Program
Course #: BI14520
April 9 - July 16, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
Register by March 5 for only $1,795.00


Trial Master Files: Why They Are Important and How to Organize Them Workshop
Course #: BI14348
April 9, 2021 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
Register by March 5 for only $850.00


10-Week Clinical Research Associate (CRA) On-Boarding Program
Course #: BI14505
April 9 - June 18, 2021 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern
Register by March 5 for only $1,795.00


10-Week Clinical Research Coordinator (CRC) On-Boarding Program
Course #: BI14508
April 9 - June 18, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
Register by March 5 for only $1,795.00


Implementing Quality Agreements
Course #: BI14347
April 9, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Auditing Techniques: A Problem-Solving Practicum
Course #: BI14349
April 12, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs
Course #: BI14350
April 12, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


State Laws Governing Clinical Trial Regulatory Compliance
Course #: BI14351
April 12, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Use of Notes to File in Clinical Trial Essential Documentation
Course #: BI14352
April 12, 2021 | Interactive Web Seminar
3:30 PM - 5:00 PM Eastern
$835.00


Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs
Course #: BI14355
April 13, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$625.00


FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
Course #: BI14353
April 13, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
Course #: BI14356
April 13, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
$835.00


The Revised HHS Common Rule: What You Need to Know Now
Course #: BI14354
April 13, 2021 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$835.00


Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
Course #: BI14359
April 14, 2021 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$735.00


Sponsor Responsibilities for Global Drug Studies
Course #: BI14361
April 14, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Investigator Initiated Trials: Roles and Responsibilities
Course #: BI14357
April 14, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$735.00


Monitoring Oncology Clinical Trials
Course #: BI14358
April 14, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Strategies for Managing Difficult Clinical Research Sites
Course #: BI14360
April 14, 2021 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$835.00


Quality Systems: A Controlled Approach to GCP Compliance
Course #: BI14362
April 15, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


The Fundamentals of Clinical Research Project Management
Course #: BI14364
April 15, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Understanding the FDA/OHRP Joint Guidance on Minutes of IRB Meetings
Course #: BI14363
April 15, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$835.00


FDA Requirements for Electronic Source Data in Clinical Investigations
Course #: BI14366
April 16, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Course #: BI14365
April 16, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$835.00


Final ICH GCP E6 R2: Impact on Clinical Data Management
Course #: BI14367
April 20, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Essential Documentation in Clinical Trials at Research Sites
Course #: BI14368
April 21, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


CAP and CLIA Requirements for Clinical Research Laboratories
Course #: BI14369
April 21, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Risk-Based Site Monitoring
Course #: BI14370
April 22, 2021 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$735.00


Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Course #: BI14372
April 26, 2021 | Interactive Web Seminar
8:30 AM - 10:30 AM Eastern
$835.00


Strategies for Having Difficult Conversations
Course #: BI14373
April 26, 2021 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$735.00


Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance
Course #: BI14371
April 26, 2021 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$835.00


NEW! ICH E8 (R1): Changes Impacting Sponsors/CROs
Course #: BI14374
April 27, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


NEW! ICH E8 (R1): Designing Quality into Clinical Studies
Course #: BI14375
April 27, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
Course #: BI14377
April 28, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
Course #: BI14376
April 28, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Subject Recruitment: Proactive Project Plans and Issues Management
Course #: BI14378
April 29, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$625.00


Centralized TMF Management: The CRO Sponsor Partnership
Course #: BI14379
May 3, 2021 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$735.00


eTMF Implementation Strategies
Course #: BI14380
May 3, 2021 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
$835.00


Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Course #: BI14383
May 4, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Effective Use of Tools, Job Aids, Process Maps, and Checklists for Project Managers and Clinical Research Teams
Course #: BI14384
May 4, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


NEW! Project Management of Phase I Oncology Trials
Course #: BI14381
May 4, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
$835.00


The IND in a CTD/eCTD Format
Course #: BI14382
May 4, 2021 | Interactive Web Seminar
2:30 PM - 4:00 PM Eastern
$735.00


Leading Teams in a Changing Clinical Research Environment
Course #: BI14386
May 5, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Medical Writing Fundamentals: How to Write Regulatory Documents
Course #: BI14385
May 5, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


30-Hour Clinical Data Management On-Boarding Program
Course #: BI14518
May 5 - July 7, 2021 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern
Register by April 2 for only $1,795.00


30-Hour Clinical Research Auditing Certification Program
Course #: BI14524
May 6 - July 29, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
Register by April 2 for only $1,795.00


Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
Course #: BI14387
May 6, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


NEW! 10-Hour Clinical Trial Start-Up Series
Course #: BI14538
May 6 - June 3, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
Register by April 2 for only $1,595.00


NEW! 10-Hour Advanced Clinical Project Management Skills Development
Course #: BI14534
May 6 - June 3, 2021 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern
Register by April 2 for only $1,595.00


10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program
Course #: BI14515
May 7 - July 9, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
Register by April 2 for only $1,695.00


Establishing Quality Tolerance Limits
Course #: BI14388
May 7, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials
Course #: BI14390
May 10, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
Course #: BI14389
May 10, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$835.00


Introduction to Clinical Research
Course #: BI14391
May 10, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Strategies for Active Listening
Course #: BI14392
May 10, 2021 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$735.00


Risk-Based Auditing: Effective Compliance Strategies
Course #: BI14395
May 11, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


Current FDA and EMA Inspection Findings: Lessons Learned
Course #: BI14396
May 11, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Building Relationships with Clinical Research Sites
Course #: BI14393
May 11, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
Course #: BI14397
May 11, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Investigational Product Accountability Best Practices
Course #: BI14398
May 11, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Root Cause Analysis: Applying the Concept for Better Study Compliance Management
Course #: BI14394
May 11, 2021 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$625.00


Monitoring Reports: 10 Rules of Effective Report Writing
Course #: BI14401
May 12, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$835.00


Data Management Plan Creation: Content and Rationale
Course #: BI14399
May 12, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
Course #: BI14400
May 12, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$835.00


Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
Course #: BI14403
May 13, 2021 | Interactive Web Seminar
12:30 PM - 2:00 PM Eastern
$835.00


Risk-Based Quality and Compliance Management in Combination Product Trials
Course #: BI14404
May 13, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Course #: BI14406
May 14, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
Course #: BI14405
May 14, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$835.00


Negotiation Skills for Clinical Research Professionals
Course #: BI14407
May 18, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Risk-Based Monitoring: The Data Management Connection
Course #: BI14408
May 19, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
Course #: BI14409
May 20, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


CRO Partnership Management
Course #: BI14410
May 21, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


NEW! General Data Protection Regulation (GDPR): Developing a Compliant Data Privacy Program
Course #: BI14411
May 21, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$625.00


Monitoring Medical Device Trials: An Introduction
Course #: BI14412
May 24, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Overseeing Teams and Projects
Course #: BI14413
May 25, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Developing and Negotiating Research Site Clinical Study Budgets and Contracts
Course #: BI14415
May 25, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


Monitoring Plan Development
Course #: BI14414
May 25, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


The GCPs of Essential Documents
Course #: BI14417
May 26, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Case Report Form Design, Strategy, and Standards
Course #: BI14416
May 26, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Sponsor Management of Investigator Non-Compliance
Course #: BI14418
May 27, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$735.00


Developing Clinical Study Budgets for Sponsors
Course #: BI14419
May 28, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series
Course #: BI14511
June 1 - August 3, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$1,895.00


EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
Course #: BI14421
June 1, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$945.00


FDA Drug Approval Process
Course #: BI14420
June 1, 2021 | Interactive Web Seminar
12:30 PM - 3:30 PM Eastern
$735.00


NEW! 10-Hour Clinical Research Manager Skills Development Series
Course #: BI14536
June 1-29, 2021 | Interactive Web Seminar
2:00 PM - 4:00 PM Eastern
Register by April 30 for only $1,595.00


10-Week Clinical Research Associate (CRA) On-Boarding Program
Course #: BI14506
June 1 - August 10, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by April 30 for only $1,795.00


Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately
Course #: BI14423
June 2, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$625.00


Approaches to Address Challenges in Vendor Management
Course #: BI14422
June 2, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$835.00


Introduction to Statistics for Non-Statisticians
Course #: BI14424
June 2, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


Writing Clinical Study Protocols
Course #: BI14425
June 3, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


Protocol Deviations: Documenting, Managing, and Reporting
Course #: BI14426
June 3, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Implementing Quality Agreements
Course #: BI14427
June 4, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


TMF/eTMF Audit Strategies
Course #: BI14428
June 4, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


ABCs of GCP and the 13 Principles of ICH GCP E6
Course #: BI14430
June 7, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


ABCs of Clinical Research for Clinical Administrative Support Staff
Course #: BI14429
June 7, 2021 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$835.00


10-Week CRA & CRC Beginner Program
Course #: BI14501
June 7 - August 23, 2021 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern
Register by May 7 for only $1,795.00


NEW! 10-Week Fundamentals of Drug Development Series
Course #: BI14541
June 7 - August 16, 2021 | Interactive Web Seminar
1:30 PM - 4:30 PM Eastern
Register by May 7 for only $1,795.00


NEW! 12-Hour Clinical Trial Management Series
Course #: BI14530
June 7 - July 19, 2021 | Interactive Web Seminar
6:00 PM - 8:00 PM Eastern
Register by May 7 for only $1,595.00


Cases in Advanced GCP: A Problem-Solving Practicum
Course #: BI14431
June 8, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


Ensuring Success Through Smarter Site Selection and Study Feasibility
Course #: BI14432
June 8, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Course #: BI14434
June 10, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


A Systematic Approach to Study Start-Up: Improving Site Activation
Course #: BI14435
June 10, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Regulatory Intelligence
Course #: BI14436
June 11, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Use of Electronic Health Record Data in Clinical Investigations
Course #: BI14438
June 14, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$835.00


Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual
Course #: BI14437
June 14, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


30-Hour Clinical Research Auditing Certification Program
Course #: BI14525
June 14 - August 30, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by May 14 for only $1,795.00


Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Final Guidance
Course #: BI14439
June 15, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Drug Development and FDA Regulations
Course #: BI14440
June 15, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$735.00


Informed Consent Procedure: Lessons Learned from Inspection Findings
Course #: BI14441
June 15, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Electronic Informed Consent Guidance: Regulatory Updates
Course #: BI14442
June 16, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
Course #: BI14443
June 16, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Principal Investigator Oversight and the Appropriate Delegation of Tasks
Course #: BI14444
June 16, 2021 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$735.00


Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results
Course #: BI14445
June 17, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Good Clinical Practice: Practical Application and Implementation
Course #: BI14446
June 17, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$835.00


Clinical Research Financial Management for Investigative Sites
Course #: BI14447
June 17, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Strategies for Remote Auditing of Investigative Sites
Course #: BI14449
June 18-25, 2021 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$1,195.00


FDA Medical Device Approval Process
Course #: BI14450
June 21, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Strategies for Building High-Performing Clinical Research Teams
Course #: BI14451
June 22, 2021 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$735.00


Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
Course #: BI14452
June 23, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Incorporating Denials Management into Clinical Research Billing
Course #: BI14453
June 24, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Case Report Form Design, Strategy, and Standards Workshop
Course #: BI14454
June 28, 2021 | Interactive Web Seminar
9:00 AM - 4:00 PM Eastern
Register by May 28 for only $850.00


Strategies for Effective Remote Monitoring
Course #: BI14455
June 28, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Data Quality in Clinical Trials: Rationale and Impact
Course #: BI14457
June 30, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
Course #: BI14458
June 30, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Writing and Updating the Investigator's Brochure
Course #: BI14456
June 30, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


30-Hour Clinical Project Management Fundamentals Certification Program
Course #: BI14521
June 30 - September 22, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by May 28 for only $1,795.00


Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
Course #: BI14459
July 1, 2021 | Interactive Web Seminar
12:30 PM - 3:00 PM Eastern
$835.00


Research Billing Processing: Appropriate Segregation of Charges and Medical Documentation
Course #: BI14460
July 6, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Introduction to Data Management
Course #: BI14462
July 7, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Writing the Clinical Study Report
Course #: BI14461
July 7, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$735.00


NEW! 10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval
Course #: BI14532
July 7 - September 15, 2021 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern
Register by June 4 for only $1,795.00


Preparing Clinical Research Sites for FDA Inspections
Course #: BI14463
July 8, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$625.00


Managing CRAs to Improve Performance and Study Outcomes
Course #: BI14464
July 8, 2021 | Interactive Web Seminar
2:00 PM - 4:30 PM Eastern
$625.00


20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research
Course #: BI14513
July 12 - August 16, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
Register by June 11 for only $1,695.00


Institutional Review Board (IRB) Written Procedures: Final Guidance for Institutions and IRBs
Course #: BI14466
July 12, 2021 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$735.00


Auditing Techniques: A Problem-Solving Practicum
Course #: BI14465
July 12, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$835.00


Sponsor Responsibilities for Global Drug Studies
Course #: BI14467
July 12, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Strategies for Managing Difficult Clinical Research Sites
Course #: BI14470
July 13, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Preparation, Management, and Response to Inspections and Audits
Course #: BI14471
July 13, 2021 | Interactive Web Seminar
10:00 AM - 2:00 PM Eastern
$1,045.00


Adverse Event Monitoring for CRAs
Course #: BI14472
July 13, 2021 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$735.00


FDA Requirements for Electronic Source Data in Clinical Investigations
Course #: BI14468
July 13, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Monitoring Oncology Clinical Trials
Course #: BI14473
July 13, 2021 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$735.00


Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
Course #: BI14469
July 13, 2021 | Interactive Web Seminar
3:30 PM - 5:00 PM Eastern
$735.00


NEW! 30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols
Course #: BI14528
July 13 - September 14, 2021 | Interactive Web Seminar
5:00 PM - 8:00 PM Eastern
Register by June 12 for only $1,795.00


Use of Notes to File in Clinical Trial Essential Documentation
Course #: BI14477
July 14, 2021 | Interactive Web Seminar
9:00 AM - 10:30 AM Eastern
$835.00


Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs
Course #: BI14475
July 14, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$625.00


Final ICH GCP E6 R2: Impact on Clinical Data Management
Course #: BI14474
July 14, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


NEW! Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management
Course #: BI14478
July 14, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Quality Systems: A Controlled Approach to GCP Compliance
Course #: BI14476
July 14, 2021 | Interactive Web Seminar
2:30 PM - 4:30 PM Eastern
$735.00


Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
Course #: BI14479
July 15, 2021 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$835.00


The Revised HHS Common Rule: What You Need to Know Now
Course #: BI14480
July 15, 2021 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$835.00


10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program
Course #: BI14516
July 16 - September 17, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
Register by June 11 for only $1,695.00


Investigator Initiated Trials: Roles and Responsibilities
Course #: BI14481
July 16, 2021 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$735.00


Coaching Skills for Leaders
Course #: BI14483
July 19, 2021 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$735.00


Source Documentation: What is Adequate and Accurate?
Course #: BI14482
July 19, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


State Laws Governing Clinical Trial Regulatory Compliance
Course #: BI14484
July 19, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


Strategies for Having Difficult Conversations
Course #: BI14485
July 19, 2021 | Interactive Web Seminar
1:30 PM - 3:00 PM Eastern
$735.00


Risk-Based Site Monitoring
Course #: BI14486
July 20, 2021 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$735.00


Essential Documentation in Clinical Trials at Research Sites
Course #: BI14487
July 20, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Managing Phase I Clinical Trials
Course #: BI14488
July 21, 2021 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$735.00


10-Week CRA & CRC Beginner Program
Course #: BI14502
July 21 - September 29, 2021 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern
Register by June 18 for only $1,795.00


CAP and CLIA Requirements for Clinical Research Laboratories
Course #: BI14490
July 22, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


30-Hour Clinical Research Auditing Certification Program
Course #: BI14526
July 22 - September 30, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
Register by June 18 for only $1,795.00


Subject Recruitment: Proactive Project Plans and Issues Management
Course #: BI14489
July 22, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$625.00


Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance
Course #: BI14491
July 26, 2021 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$835.00


Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Course #: BI14492
July 26, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


Monitoring Visit Reports for Medical Device Studies
Course #: BI14493
July 26, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
Course #: BI14494
July 27, 2021 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$835.00


Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
Course #: BI14495
July 28, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$835.00


Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
Course #: BI14496
July 28, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$835.00


NEW! ICH E8 (R1): Designing Quality into Clinical Studies
Course #: BI14497
July 29, 2021 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$735.00


NEW! ICH E8 (R1): Changes Impacting Sponsors/CROs
Course #: BI14498
July 29, 2021 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$735.00


30-Hour Clinical Project Management Fundamentals Certification Program
Course #: BI14522
July 30 - October 8, 2021 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
Register by June 25 for only $1,795.00