Trial Master File Management

The Trial Master File (TMF) is the backbone of your trial’s documentation, providing a comprehensive record of all essential documents. These documents demonstrate strict adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements, a matter of utmost importance in the field of clinical trials.

Our team is dedicated to ensuring that your TMF is always diligently organized, up-to-date, and audit-ready. We understand the complexities of managing essential documents across all clinical trial phases. From study initiation through close-out, we ensure that every document is appropriately categorized, version-controlled, and securely stored, providing you with peace of mind about the safety of your data.

Key components of our TMF services Include:

Document Creation and Maintenance

We assist in creating, collecting, and maintaining all essential documents, ensuring they meet regulatory standards and are easily accessible for review.

Regulatory Compliance

Our experts manage the TMF with a focus on compliance, ensuring that all documents meet the stringent requirements of GCP, ICH, and local regulatory authorities.

Real-Time Access and Updates

With our advanced eTMF solutions, sponsors and stakeholders have real-time access to the TMF, allowing for immediate updates and seamless collaboration across all trial sites.

Audit Readiness

We regularly review and audit the TMF to ensure it is inspection-ready at any point during the trial. Our proactive approach minimizes the risk of non-compliance and enhances the overall quality of your clinical trial.

Site-Specific Files

We manage Investigator Site Files (ISFs) in alignment with the TMF, ensuring consistency and completeness of documentation across all participating sites.

Testimonials

Read our client testimonials about their experiences on working together with Research Drive.

Alex Gage: Director & Head of Clinical Operations

Research Drive and QRCC have collaborated for several years to support the deliver of early phase clinical trials in The Netherlands and Germany. The Research Drive team’s professionalism, industry knowledge and commitment to providing the highest possible level of support are truly commendable. I highly recommend Research Drive to anyone requiring clinical operations and regulatory support in The Netherlands and across mainland Europe.

Emma Hilton: Senior Clinical Project Manager

Research Drive has supported several of our Phase 1 projects by providing high-quality monitoring services. The CRAs assigned to our studies were dedicated professionals with exceptional attention to detail and consistently upheld high standards of reporting throughout the duration of each study.

Communication with the Research Drive team was excellent—they were proactive, responsive, and built strong relationships not only with the study sites but also with us, the Sponsor.

It has been a pleasure working with the Research Drive team, and I would highly recommend their services.

Graham Morrison: Clinical Operation Manager

I have worked with the team at Research Drive for many years now. They have worked on multiple complex studies and their CRAs and support team have demonstrated their skill and wealth of knowledge to ensure delivery of projects. They have developed strong relationships with both sites and sponsors, through clear communication. Training of their employees is a continual process in Research Drive and their CRAs are highly skilled and capable of dealing with the challenges that running complex studies bring. I always had peace of mind knowing that the studies were being run to the highest standards. I wouldn’t hesitate to recommend Research Drive for their skills, knowledge and understanding of the clinical research environment. I would hope to work with them again on future projects.

Clinical Research Coordinator

An incredibly pleasant collaboration during a highly complex study in the Netherlands. Problems were always resolved immediately, with very quick responses. Helpful, friendly, and professional. Highly recommended!

Senior Director, Clinical Development

Working for a small biotech company, we do not have the internal resources to manage all aspects of our clinical trials. In working with ResearchDrive, they have created a relationship where we all feel part of the same team and that ReserachDrive is looking out for our best interests with a team of experienced individuals.