Our Services | Clinical Trial Supplies
We have wide experience in manufacturing and despatching Investigational Medicinal Products for clinical trials worldwide – from small bioavailability studies through to multinational Phase III trials. We propose and manage solutions specific to particular trials, or work with your existing manufacturers to ensure that the supplies comply with legal requirements.
Our Virtual Quality Management™ product provides a cost-effective means of meeting regulatory authority expectations for Good Manufacturing Practice
Somerset House Consultants supports your trial from initial planning through to the final report, including:
- Ensuring compliance with Good Clinical Practice, Good Manufacturing Practice and legislative requirements
- Qualified Person release of clinical trial supplies
- Selection and auditing of manufacturers
- Setting up Technical Agreements with manufacturers
- Maintaining Product Specification Files
- Ensuring that manufacturers have the latest versions of specifications, processes and methods
- Ensuring that documentation and retention samples are stored securely
- Maintaining an effective ordering and despatch system
- Maintaining an effective product recall system
Recent Clinical Trials Projects --> |