Products
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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 -
Principal Investigator Oversight and the Appropriate Delegation of Tasks -
Protocol Deviations: Documenting, Managing, and Reporting -
Quality Systems: A Controlled Approach to GCP Compliance -
Quality Systems: A Controlled Approach to GCP Compliance -
Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada -
RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials -
Regulatory Intelligence -
Research Billing Processing: Leveraging Technology to Maintain Compliance and Mitigate Risk -
Risk-Based Auditing: Effective Compliance Strategies -
Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA -
Risk-Based Quality and Compliance Management in Combination Product Trials -
Risk-Based Site Monitoring -
Risk-Based Site Monitoring -
Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management -
Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management -
Root Cause Analysis: Applying the Concept for Better Study Compliance Management -
Source Documentation: What is Adequate & Accurate? -
Source Documentation: What is Adequate & Accurate?
