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UPCOMING LIVE SEMINARS
Clinical Project Management: Fundamentals of Project Management
June 7-8, 2021
Boston, MA
Monitoring Clinical Drug Studies: Beginner
June 9-11, 2021
Boston, MA
CRA & CRC: Beginner Program
June 14-16, 2021
San Diego, CA
Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management
June 16-17, 2021
San Diego, CA
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Publications
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Glossary Acronyms for Clinical Research Professionals
State by State Clinical Trial Requirements (Print)
State-by-State Clinical Trial Requirements Reference Guide 2012 (electronic)
The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors
Expediting Drug and Biologics Development: A Strategic Approach 2006
New Drug Development: A Regulatory Overview (8th Edition)
Good Clinical Practice: A Question & Answer Reference Guide 2017 (Electronic)
CFR/ICH GCP Reference Guide 2018
CFR/ICH GCP Reference Guide for Medical Devices 2018
Good Clinical Practice: A Question & Answer Reference Guide 2018
Good Clinical Practice: A Question & Answer Reference Guide 2018 (Electronic)
PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019 (Hard Copy)
PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019 (Electronic + Hard Copy)
CFR/ICH GCP Reference Guide for Medical Devices 2019
Study Site Training Series (2018): A 6-Volume Self-Instructional Training Series for Investigative Teams
Study Site Training Series (2018): Volume 1: The Clinical Study Site Team: Roles and Responsibilities
Study Site Training Series (2018): Volume 2: FDA Clinical Research Regulations and GCPs: The Essentials
Study Site Training Series (2018): Volume 3: IRBs/IECs and Informed Consent: Protecting the Rights of Human Subjects
Study Site Training Series (2018): Volume 4: Sponsor Visits and Regulatory Audits: What You Need to Know
Study Site Training Series (2018): Volume 5: Your Role in Reporting Adverse Experiences
Live Seminars
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Web Seminars
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The IND in a CTD/eCTD Format
February 2, 2021 | Interactive Web Seminar
Medical Writing Fundamentals: How to Write Regulatory Documents
February 2, 2021 | Interactive Web Seminar
Strategies for Active Listening
February 3, 2021 | Interactive Web Seminar
Drug Development and FDA Regulations
February 18, 2021 | Interactive Web Seminar
Introduction to Clinical Research
February 19, 2021 | Interactive Web Seminar
10-Week Clinical Research Associate (CRA) On-Boarding Program
February 23 - May 25, 2021 | Interactive Web Seminar
Introduction to Statistics for Non-Statisticians
March 2, 2021 | Interactive Web Seminar
10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series
March 2 - May 4, 2021 | Interactive Web Seminar
ABCs of Clinical Research for Clinical Administrative Support Staff
March 3, 2021 | Interactive Web Seminar
FDA Drug Approval Process
March 3, 2021 | Interactive Web Seminar
Writing and Updating the Investigator's Brochure
March 9, 2021 | Interactive Web Seminar
Writing Clinical Study Protocols
March 9, 2021 | Interactive Web Seminar
Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
March 9, 2021 | Interactive Web Seminar
Good Clinical Practice: Practical Application and Implementation
March 10, 2021 | Interactive Web Seminar
Clinical Trial Registration: Requirements, Record Maintenance and Reporting of Results
March 15, 2021 | Interactive Web Seminar
Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
March 16, 2021 | Interactive Web Seminar
Regulatory Intelligence
March 22, 2021 | Interactive Web Seminar
Coaching Skills for Leaders
April 5, 2021 | Interactive Web Seminar
Writing the Clinical Study Report
April 6, 2021 | Interactive Web Seminar
10-Week Clinical Research Associate (CRA) On-Boarding Program
April 9 - June 18, 2021 | Interactive Web Seminar
Archived Web Seminars
Archive: Introduction to Clinical Research
November 17, 2020 •
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Archive: Writing Clinical Study Protocols
November 16, 2020 •
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Archive: Good Clinical Practice: Practical Application and Implementation
September 24, 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
September 21, 2020 •
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Archive: Writing the Clinical Study Report
January 15, 2020 •
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Archive: The IND in a CTD/eCTD Format
December 18, 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
December 16, 2019 •
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Archive: Introduction to Statistics for Non-Statisticians
November 18, 2019 •
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Archive: ABCs of Clinical Research for Clinical Administrative Support Staff
September 3, 2019 •
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Archive: Drug Development and FDA Regulations
July 16, 2019 •
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Archive: FDA Drug Approval Process
June 3, 2019 •
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Archive: Regulatory Intelligence
May 22, 2019 •
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Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
April 10, 2019 •
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Archive: Strategies for Having Difficult Conversations
March 26, 2019 •
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Archive: Coaching Skills for Leaders
February 7, 2019 •
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Archive: Writing and Updating the Investigator's Brochure
May 9, 2018 •
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Archive: Writing and Maintaining the EU Clinical Trial Authorization
November 8, 2017 •
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Archive: Clinical Trials and the Sunshine Act
November 3, 2015 •
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Archive: Writing Protocols for Diagnostic Studies
April 15, 2015 •
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Archive: Writing Clinical Study Reports for Diagnostic Studies
October 17, 2013 •
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