On-site Study Management

At Research Drive, we go beyond monitoring visits alone. We understand that sites face limited resources, staffing challenges, and tight timelines. This is why we offer tailored on-site support services to bridge resource gaps and ensure operational excellence at every site.

Our team of professionals, all with strong clinical backgrounds, ensure strategic, high-quality assistance across all trial processes. Their proactive approach ensures sites’ needs align with sponsor expectations, creating measurable value in every partnership.

When operational capacity matters, Research Drive enhances site performance, by designing support packages to fit your study’s specific needs. Whether you need short-term, part-time, or continues support, we tailor our services to meet the specific needs of your study.

Key components of our on-site support:

Data Entry & Quality Checks

We ensure accurate, timely data entry into Electronic Data Capture (EDC) systems, supporting sites in meeting database timelines while maintaining data integrity. Our team also assists with data review and source data verification, helping ensure completeness and consistency across trial records.

Query Resolution

Unresolved queries are a common cause of a delay in a clinical trial. Our professionals proactively manage and resolve queries quickly and efficiently, in close coordination and corporation with site staff and sponsors. By identifying and addressing issues efficiently, faster data review is facilitated, which results in smooth database clean or lock timelines.

Investigator Site File (ISF) Maintenance

A well-maintained and inspection-ready Investigator Site File (ISF) is critical for demonstrating GCP compliance and ensuring a smooth regulatory inspection. Our team assists in essential version-controlled document filing, and aligned with GCP sponsor and regulatory requirements.

We proactively assist in identifying missing or outdated documentation, support reconciliation with the Trial Master File (TMF), and help site staff stay audit-ready at all times. Whether during start-up, ongoing maintenance, or close-out, our ISF support helps reduce site burden and strengthens inspection preparedness.

Testimonials

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

Susana Bule: Senior Director, Regulatory Affairs Study Start-up

It has been a privilege to collaborate with Research Drive over the past several years. Throughout our partnership, they have consistently demonstrated a high level of professionalism, expertise, and reliability. Most notably, they have approached our collaboration with a true spirit of partnership, working alongside us to achieve shared goals.
We are sincerely grateful for the opportunity to work with such a committed and capable team, and we look forward to continuing this valuable relationship for many years to come

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 Research Drive, they have created a relationship where we all feel part of the same team and that Research Drive is looking out for our best interests with a team of experienced individuals.