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Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
Course #: BI15360
November 9, 2022
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Archive: ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors
Course #: BI15457
August 29, 2022
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Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
Course #: BI15034
July 8, 2022
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Archive: ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
Course #: BI14893
February 24, 2022
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Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
Course #: BI14880
February 16, 2022
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Archive: Developing Clinical Study Budgets for Sponsors
Course #: BI14870
February 7, 2022
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Archive: Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
Course #: BI14758
January 27, 2022
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Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility
Course #: BI14721
December 16, 2021
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Archive: Electronic Informed Consent Guidance: Regulatory Updates
Course #: BI14780
December 15, 2021
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Archive: Strategies for Managing Difficult Clinical Research Sites
Course #: BI14815
October 25, 2021
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Archive: Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
Course #: BI14652
October 15, 2021
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Archive: TMF/eTMF Audit Strategies
Course #: BI14651
October 15, 2021
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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Course #: BI14617
September 10, 2021
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Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
Course #: BI14498
July 29, 2021
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Archive: Investigator Initiated Trials: Roles and Responsibilities
Course #: BI14481
July 16, 2021
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Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Course #: BI14406
May 14, 2021
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Archive: State Laws Governing Clinical Trial Regulatory Compliance
Course #: BI14351
April 12, 2021
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Archive: Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
Course #: BI14334
March 30, 2021
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Archive: Strategies for Remote Auditing of Investigative Sites
Course #: BI14320
March 12, 2021
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Archive: Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
Course #: BI14313
March 10, 2021
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WebSeminarArchive
Archive: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Course #: BI14286
February 17, 2021
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Archive: ICH E8 (R1): Designing Quality into Clinical Studies
Course #: BI14242
January 14, 2021
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Archive: Overseeing Teams and Projects
Course #: BI14127
November 25, 2020
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Archive: Introduction to Clinical Research
Course #: BI14118
November 17, 2020
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Archive: Writing Clinical Study Protocols
Course #: BI14083
November 16, 2020
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Archive: The GCPs of Essential Documents
Course #: BI14112
November 11, 2020
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Archive: Data Management Plan Creation: Content and Rationale
Course #: BI14113
November 11, 2020
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Archive: Protocol Deviations: Documenting, Managing, and Reporting
Course #: BI14111
November 10, 2020
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Archive: Risk-Based Site Monitoring
Course #: BI14091
October 27, 2020
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Archive: Monitoring Medical Device Trials: An Introduction
Course #: BI14087
October 22, 2020
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Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
Course #: BI14086
October 22, 2020
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Archive: Data Quality in Clinical Trials: Rationale and Impact
Course #: BI14072
October 14, 2020
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Archive: Case Report Form Design, Strategy, and Standards
Course #: BI14062
September 30, 2020
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Archive: Good Clinical Practice: Practical Application and Implementation
Course #: BI14056
September 24, 2020
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Archive: Final ICH GCP E6 R2: Impact on Clinical Data Management
Course #: BI14052
September 23, 2020
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Archive: Monitoring Reports: 10 Rules of Effective Report Writing
Course #: BI14053
September 23, 2020
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Archive: Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
Course #: BI14049
September 21, 2020
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Archived: The Revised HHS Common Rule: What You Need to Know Now
Course #: BI14542
September 18, 2020
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Archive: Cases in Advanced GCP: A Problem-Solving Practicum
Course #: BI14044
September 16, 2020
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Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Course #: BI14041
September 14, 2020
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Archive: eTMF Quality Oversight: A Risk-Based Approach
Course #: BI14039
September 11, 2020
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Archive: Establishing Quality Tolerance Limits
Course #: BI14018
August 13, 2020
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Archive: Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Course #: BI13983
July 21, 2020
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Archive: Preparing Clinical Research Sites for FDA Inspections
Course #: BI13959
July 15, 2020
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Archive: Auditing Techniques: A Problem-Solving Practicum
Course #: BI13948
July 9, 2020
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Archive: Strategies for Effective Remote Monitoring
Course #: BI14218
June 1, 2020
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Archive: Leading Teams in a Changing Clinical Research Environment
Course #: BI13909
May 27, 2020
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Archive: Quality Systems: A Controlled Approach to GCP Compliance
Course #: BI13905
May 22, 2020
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Archive: The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
Course #: BI13892
May 13, 2020
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Archive: CAP and CLIA Requirements for Clinical Research Laboratories
Course #: BI13890
May 12, 2020
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Archive: Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
Course #: BI13886
May 7, 2020
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Archive: Managing Clinical Trials During the COVID-19 Pandemic
Course #: BI14199
April 27, 2020
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Archive: Centralized TMF Management: The CRO Sponsor Partnership
Course #: BI13877
April 24, 2020
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Archive: Investigational Product Accountability Best Practices
Course #: BI13876
April 23, 2020
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Archive: Essential Documentation in Clinical Trials at Research Sites
Course #: BI13867
April 14, 2020
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Archive: Risk-Based Auditing: Effective Compliance Strategies
Course #: BI13837
March 18, 2020
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Archive: Approaches to Address Challenges in Vendor Management
Course #: BI13819
March 3, 2020
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Archive: Source Documentation: What is Adequate and Accurate?
Course #: BI13743
January 15, 2020
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Archive: Writing the Clinical Study Report
Course #: BI13741
January 15, 2020
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Archive: Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
Course #: BI13731
December 19, 2019
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Archive: EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
Course #: BI13718
December 19, 2019
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Archive: The IND in a CTD/eCTD Format
Course #: BI13722
December 18, 2019
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Archive: Sponsor Responsibilities for Global Drug Studies
Course #: BI13729
December 17, 2019
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Archive: Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
Course #: BI13769
December 16, 2019
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Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
Course #: BI13714
December 9, 2019
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Archive: CRO Partnership Management
Course #: BI13617
December 6, 2019
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Archive: Managing CRAs to Improve Performance and Study Outcomes
Course #: BI13706
December 3, 2019
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Archive: Implementing Quality Agreements
Course #: BI13686
November 22, 2019
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Archive: Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual
Course #: BI13692
November 19, 2019
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Archive: Introduction to Statistics for Non-Statisticians
Course #: BI13689
November 18, 2019
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Archive: Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
Course #: BI13688
November 18, 2019
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Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings
Course #: BI13672
November 4, 2019
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Archive: Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance
Course #: BI13649
October 21, 2019
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Archive: A Systematic Approach to Study Start-Up: Improving Site Activation
Course #: BI13764
October 18, 2019
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Archive: Introduction to Data Management
Course #: BI13647
October 16, 2019
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Archive: RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
Course #: BI13635
September 24, 2019
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Archive: Use of Electronic Health Record Data in Clinical Investigations
Course #: BI13630
September 18, 2019
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Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
Course #: BI13626
September 17, 2019
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Archive: ABCs of Clinical Research for Clinical Administrative Support Staff
Course #: BI13612
September 3, 2019
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Archive: Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
Course #: BI13762
August 28, 2019
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Archive: Managing Phase I Clinical Trials
Course #: BI13757
August 12, 2019
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Archive: Monitoring Oncology Clinical Trials
Course #: BI13595
August 1, 2019
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Archive: Drug Development and FDA Regulations
Course #: BI13520
July 16, 2019
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Archive: FDA Drug Approval Process
Course #: BI13482
June 3, 2019
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Archive: Developing and Negotiating Research Site Clinical Study Budgets and Contracts
Course #: BI13491
May 30, 2019
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Archive: Risk-Based Monitoring: The Data Management Connection
Course #: BI13489
May 29, 2019
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Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
Course #: BI13485
May 23, 2019
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Archive: Regulatory Intelligence
Course #: BI13462
May 22, 2019
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Archive: ABCs of GCP and the 13 Principles of ICH GCP E6
Course #: BI13475
May 10, 2019
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Archive: Root Cause Analysis: Applying the Concept for Better Study Compliance Management
Course #: BI13469
May 9, 2019
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Archive: Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
Course #: BI13468
May 2, 2019
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Archive: Current FDA and EMA Inspection Findings: Lessons Learned
Course #: BI13467
May 2, 2019
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Archive: Monitoring Visit Reports for Medical Device Studies
Course #: BI13461
April 30, 2019
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Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
Course #: BI13444
April 10, 2019
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Archive: Strategies for Having Difficult Conversations
Course #: BI13425
March 26, 2019
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WebSeminarArchive
Archive: Building Relationships with Clinical Research Sites
Course #: BI13420
March 20, 2019
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WebSeminarArchive
Archive: Principal Investigator Oversight and the Appropriate Delegation of Tasks
Course #: BI13419
March 19, 2019
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WebSeminarArchive
Archive: Monitoring Plan Development
Course #: BI13403
February 21, 2019
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Archive: Coaching Skills for Leaders
Course #: BI13363
February 7, 2019
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WebSeminarArchive
Archive: Adverse Event Monitoring for CRAs
Course #: BI13389
January 16, 2019
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WebSeminarArchive
Archive: Use of Notes to File in Clinical Trial Essential Documentation
Course #: BI13283
November 13, 2018
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WebSeminarArchive
Archive: Subject Recruitment: Proactive Project Plans and Issues Management
Course #: BI13181
July 20, 2018
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WebSeminarArchive
Archive: Preparation, Management, and Response to Inspections and Audits
Course #: BI13152
June 5, 2018
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Archive: Writing and Updating the Investigator's Brochure
Course #: BI13122
May 9, 2018
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WebSeminarArchive
Archive: Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
Course #: BI13121
May 8, 2018
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WebSeminarArchive
Archive: FDA Medical Device Approval Process
Course #: BI13119
May 7, 2018
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WebSeminarArchive
Archive: Tools for Trainers: Clinical Research Job-Aids and Checklists
Course #: BI13112
May 2, 2018
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Archive: Adequate Sponsor Monitoring Systems In Anticipation of FDA Sponsor GCP Inspections
Course #: BI13024
January 30, 2018
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Archive: Writing and Maintaining the EU Clinical Trial Authorization
Course #: BI12948
November 8, 2017
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Archive: eTMF Implementation Strategies
Course #: BI12764
June 2, 2017
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Archive: Data Management in the Electronic Data Capture Arena
Course #: BI12719
April 11, 2017
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Archive: Case Narrative Writing for Reporting Adverse Events
Course #: BI12698
March 23, 2017
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Archive: Final AE Regulatory Guidance
Course #: BI12682
March 13, 2017
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Archive: Quality by Design in Clinical Research: Is This Only for the Protocol?
Course #: BI12613
December 7, 2016
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Archive: Fraud in Clinical Research: An Overview
Course #: BI12588
November 9, 2016
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Archive: EMA and FDA Inspections: Key Differences and Similarities
Course #: BI12570
October 25, 2016
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Archive: Final FDA Guidance: How to Complete the Form FDA 1572
Course #: BI12541
October 3, 2016
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Archive: CRO Selection Criteria, Eval, & Establishing the Relationship
Course #: BI12517
September 16, 2016
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Archive: Establishing a Risk Management Framework for Clin Trial Conduct
Course #: BI12493
August 24, 2016
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Archive: Detecting Risk Signals in Protocols, Data, and Monitoring
Course #: BI12443
July 19, 2016
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Archive: Re-Engineering the RFP and Bid Defense Meeting
Course #: BI12385
May 4, 2016
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Archive: Annual GCP Training Update: MHRA Inspection Findings for 2015
Course #: BI12464
February 29, 2016
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Archive: Subject Enrollment: Creating Effective Enrollment Models
Course #: BI12303
February 8, 2016
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Archive: Principal Investigator/Site GCP Compliance and Performance
Course #: BI12456
February 3, 2016
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Archive: Data Management: Key Regulations Impacting the Role of the CDM
Course #: BI12244
January 12, 2016
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Archive: SDTM and CDASH: What's the Connection?
Course #: BI12242
January 12, 2016
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Archive: Quality Risk Management in Clinical Trials and Pharmacovigilance
Course #: BI12227
December 10, 2015
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Archive: Study Feasibility: Eliminating Low and Late Enrollment
Course #: BI12201
November 24, 2015
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Archive: Sponsor Management of Investigator Non-Compliance
Course #: BI12212
November 20, 2015
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Archive: Establishing a Vendor Management Program
Course #: BI12206
November 16, 2015
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Archive: Clinical Trials and the Sunshine Act
Course #: BI12194
November 3, 2015
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Archive: Critical Decision Points in Design and Conduct of Patient Reg.
Course #: BI12139
September 17, 2015
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Archive: Strategies for Developing Effective Training & Facilitation Skills
Course #: BI12062
July 23, 2015
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Archive: Strategies for Ensuring Good Documentation Practices (GDP)
Course #: BI12087
June 25, 2015
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Archive: Principal Investigator Training: Roles and Responsibilities
Course #: BI12005
May 18, 2015
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Archive: Improving Readability of SOPs and Other Procedural Documents
Course #: BI11993
May 5, 2015
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Archive: Writing Protocols for Diagnostic Studies
Course #: BI11974
April 15, 2015
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Archive: Strategies for Conducting Vendor Audits
Course #: BI12015
April 3, 2015
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Archive: Quality by Design: A Lean Six Sigma Approach to Risk-Based Mon.
Course #: BI11952
March 24, 2015
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Archive: Study Initiation Strategies for Sponsors: Study and Site Start-Up
Course #: BI11945
March 13, 2015
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Archive: Risk-Based Monitoring for Sites: Prepare Your Site for Success
Course #: BI11808
December 1, 2014
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Archive: Using Data to Identify Risk Indicators in Risk-Based Monitoring
Course #: BI11863
August 29, 2014
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Archive: Social Media in Clinical Research
Course #: BI11706
August 22, 2014
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Archive: Auditor Emotional Intelligence
Course #: BI11680
June 11, 2014
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Archive: Monitoring Phase I Clinical Trials
Course #: BI11625
May 23, 2014
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Archive: Study Site Start-Up: Organization and Management Tips
Course #: BI11607
May 6, 2014
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Archive: Phase I Study Management
Course #: BI11577
April 11, 2014
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Archive: Writing Quality SOPs:Guidelines, Tools, Templates for SOP Creation
Course #: BI11556
March 21, 2014
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Archive: Strategies for Protocol Operationalization and Adherence
Course #: BI11549
March 17, 2014
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Archive: Real-World Monitoring: Tips for Success and Sanity
Course #: BI11464
January 16, 2014
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Archive: Preparing for SOP Inspection: An Auditor's Perspective
Course #: BI11430
December 5, 2013
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Archive: Trial Master File (TMF) for Research Sites: Set-Up and Maintenance
Course #: BI11387
October 25, 2013
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Archive: Writing Clinical Study Reports for Diagnostic Studies
Course #: BI11481
October 17, 2013
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Archive: GCP Training for Investigators
Course #: BI11237
June 20, 2013
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Archive: Informed Consent Content & Process Requirements
Course #: BI11231
June 10, 2013
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Archive: Managing Observational Studies
Course #: BI10968
August 23, 2012
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Archive: Writing SOPs and Procedural Documents
Course #: BI10967
August 22, 2012
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Archive: Design Considerations for GCP Training Programs
Course #: BI10852
May 2, 2012
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Archive: CRC Role/Responsibilities Training
Course #: BI10837
April 24, 2012
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Archive: Implementation of Procedural Documents
Course #: BI10801
March 16, 2012
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Archive: Five Key Strategic Steps for Developing Global SOPs
Course #: BI10795
March 1, 2012
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Archive: SOP on SOPs and Procedural Document Templates
Course #: BI10785
February 20, 2012
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Archive: Procedural Document System: Organized Development
Course #: BI10762
February 1, 2012
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Archive: Investigator Selection Criteria & Strategies
Course #: BI10761
January 31, 2012
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Archive: Site Management and the Art of Assertiveness
Course #: BI10478
March 24, 2011
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Archive: Making Good Teams Better: Taking Your Cross-Functional Global Team
Course #: BI10357
November 11, 2010
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Archive: Presentation Skills Training for Clinical Research Professionals
Course #: BI10352
November 9, 2010
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Archive: Introduction to the FDA
Course #: BI10337
October 25, 2010
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Archive: Medical Device Tracking
Course #: BI10280
August 18, 2010
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Archive: Transitioning Pharma Professionals to Medical Device Professionals
Course #: BI10166
April 5, 2010
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