Quality Assurance and Auditing

At Research Drive, we understand the importance of maintaining the highest standards in clinical research. Our Quality Assurance (QA) and Auditing services are designed to ensure compliance with regulatory requirements, industry standards, and the most stringent quality controls. By conducting comprehensive audits and reviews, we help our clients safeguard the integrity of their clinical trials and ensure accurate, reliable, and reproducible results.

Our QA and auditing services include:

Compliance Audits

Thorough assessments of clinical trials, sites, and documentation to confirm adherence to local and international regulations (GxP, ICH, FDA, EMA, etc.).

Process Audits

Evaluation of clinical operations, data management, and reporting procedures to identify inefficiencies and improve processes.

Vendor Audits

Assessments of third-party vendors, including clinical laboratories, CROs, and contract manufacturers, to ensure their operations meet industry standards and contractual obligations.

Inspection Readiness

Pre-inspection audits are used to prepare clients for regulatory bodies’ inspections, ensuring all necessary documentation and processes are in place.

Training & Support

Training clinical teams and stakeholders on quality management systems, GxP compliance, and best practices.

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.