Clinical Quality

GCP Consultancy

Trial document quality review

Developing high-quality documents and plans when planning a clinical trial is essential to ensure comprehensive and effective management of every aspect of the study. These documents and plans collectively guarantee that the trial is conducted efficiently, ethically, and in compliance with all necessary guidelines and regulations.

Our Trial document quality reviews ensure that all your trial-specific documents meet regulatory standards and align with your operational processes. We conduct thorough reviews to identify gaps, inconsistencies, and areas for improvement, ensuring your documentation is accurate, complete, and compliant.

Protocol de-risking

Risk Management Plan

Monitoring strategy

Clinical Study Reports

General GCP Consultancy

We provide comprehensive GCP quality advice to support you on setting up and running your clinical trials.

Our expert quality guidance ensures adherence to Good Clinical Practice standards, improving the quality of your clinical research operations.

Support for general questions about GCP and its implementation

Issue Management, CAPA Plan development and implementation support

Quality Agreement development or review

Gap analyses

GCP Supplier management