Products

Managing Successful Pre-IND/IDE Meetings with the FDA

Mastering Clinical Research Audits: Effective Responses and CAPA Development

Medical Device Development: Regulation and Law (2020)

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Monitoring Clinical Drug Studies: Advanced

Monitoring Clinical Drug Studies: Beginner

Monitoring Clinical Drug Studies: Intermediate

Monitoring Medical Device Trials: An Introduction

Monitoring Oncology Clinical Trials

Monitoring Visit Reports for Medical Device Studies

Navigating FDA's June 2024 BIMO Inspection Guidance: A Practical Approach

New Drug Development: A Regulatory Overview (8th Edition)

On-Demand 30-Hour Clinical Research Coordinator On-Boarding Program

Overcoming Site Challenges: Managing Sponsor Payment Delays

Overseeing Teams and Projects

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019 (Electronic + Hard Copy)

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2018/2019 (Hard Copy)

Preparation, Management, and Response to Inspections and Audits

Preparing Clinical Research Sites for FDA Inspections

Preparing Clinical Research Sites for FDA Inspections

Principal Investigator Oversight and the Appropriate Delegation of Tasks

Protocol Deviations: Documenting, Managing, and Reporting

Quality and Process Improvement Techniques and Tools