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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
Displaying items 1 to 20 of 34

Monitoring Clinical Drug Studies: Advanced - VIRTUAL
March 8-9, 2021 |

Monitoring Clinical Drug Studies: Beginner - VIRTUAL
March 10-12, 2021 |

Clinical Project Management: Fundamentals of Project Management - VIRTUAL
March 15-16, 2021 |

Comprehensive Monitoring for Medical Devices - VIRTUAL
March 15-17, 2021 |

CRA & CRC: Beginner Program - VIRTUAL
March 15-17, 2021 |

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance - VIRTUAL
March 17-18, 2021 |

Statistical Concepts for Non-Statisticians - VIRTUAL
March 17-18, 2021 |

Clinical Trial Assistant Fundamentals - VIRTUAL
March 18-19, 2021 |

Introduction to Clinical Research - VIRTUAL
March 18-19, 2021 |

Conducting Clinical Trials Under ICH GCP E6 - VIRTUAL
March 22-23, 2021 |

Clinical Project Management: Advanced Concepts in Project Management - VIRTUAL
March 22-23, 2021 |

Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management - VIRTUAL
March 22-23, 2021 |

Soft Skills Development for Clinical Research Professionals - VIRTUAL
March 24-25, 2021 |

Monitoring Clinical Drug Studies: Intermediate - VIRTUAL
March 24-25, 2021 |

Auditing Techniques for Clinical Research Professionals - VIRTUAL
March 24-25, 2021 |

Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators - VIRTUAL
March 24-25, 2021 |

WORKSHOP: Trial Master Files: Why They Are Important and How to Organize Them - VIRTUAL
March 25, 2021 |

Clinical Project Management: Fundamentals of Project Management
June 7-8, 2021 | Boston, MA

Monitoring Clinical Drug Studies: Beginner
June 9-11, 2021 | Boston, MA

Statistical Concepts for Non-Statisticians
June 14-15, 2021 | Boston, MA

Web Seminars
Displaying items 1 to 20 of 225
Subject Recruitment: Proactive Project Plans and Issues Management
January 26, 2021 | Interactive Web Seminar
Auditing Techniques: A Problem-Solving Practicum
January 27, 2021 | Interactive Web Seminar
Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
January 28, 2021 | Interactive Web Seminar
Use of Notes to File in Clinical Trial Essential Documentation
January 28, 2021 | Interactive Web Seminar
Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
January 29, 2021 | Interactive Web Seminar
Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
January 29, 2021 | Interactive Web Seminar
30-Hour Clinical Project Management Fundamentals Certification Program
February 2 - April 27, 2021 | Interactive Web Seminar
Strategies for Active Listening
February 3, 2021 | Interactive Web Seminar
Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
February 4, 2021 | Interactive Web Seminar
Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and the EMA Reflection Paper Risk Based Quality Management in Clinical Trials
February 5, 2021 | Interactive Web Seminar
Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
February 8, 2021 | Interactive Web Seminar
Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
February 9, 2021 | Interactive Web Seminar
Case Report Form Design, Strategy, and Standards
February 9, 2021 | Interactive Web Seminar
The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
February 10, 2021 | Interactive Web Seminar
Leading Teams in a Changing Clinical Research Environment
February 10, 2021 | Interactive Web Seminar
Current FDA and EMA Inspection Findings: Lessons Learned
February 10, 2021 | Interactive Web Seminar
Sponsor Management of Investigator Non-Compliance
February 11, 2021 | Interactive Web Seminar
Monitoring Plan Development
February 12, 2021 | Interactive Web Seminar
Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
February 15, 2021 | Interactive Web Seminar
Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials
February 15, 2021 | Interactive Web Seminar

Archived Web Seminars
Displaying items 1 to 20 of 136
Archive: Overseeing Teams and Projects
November 25, 2020 •
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Archive: Introduction to Clinical Research
November 17, 2020 •
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Archive: The GCPs of Essential Documents
November 11, 2020 •
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Archive: Protocol Deviations: Documenting, Managing, and Reporting
November 10, 2020 •
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Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
November 3, 2020 •
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Archive: Risk-Based Site Monitoring
October 27, 2020 •
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Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
October 22, 2020 •
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Archive: Monitoring Medical Device Trials: An Introduction
October 22, 2020 •
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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
October 16, 2020 •
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Archive: Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance
October 14, 2020 •
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Archive: Data Quality in Clinical Trials: Rationale and Impact
October 14, 2020 •
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Archive: Case Report Form Design, Strategy, and Standards
September 30, 2020 •
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Archive: Good Clinical Practice: Practical Application and Implementation
September 24, 2020 •
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Archive: Monitoring Reports: 10 Rules of Effective Report Writing
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
September 21, 2020 •
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Archived: The Revised HHS Common Rule: What You Need to Know Now
September 18, 2020 •
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Archive: Cases in Advanced GCP: A Problem-Solving Practicum
September 16, 2020 •
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Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
September 14, 2020 •
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Archive: eTMF Quality Oversight: A Risk-Based Approach
September 11, 2020 •
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Archive: Establishing Quality Tolerance Limits
August 13, 2020 •
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