Clinical trial project management: when and what to outsource?

Clinical trials involve many parallel activities, from study planning and regulatory and ethics submissions to site coordination, documentation, vendor management, monitoring and reporting. Keeping these activities aligned requires clear responsibilities, consistent follow-up and effective communication throughout the study.

For sponsors, the question is often not simply whether to outsource project management, but which activities require external support and at what stage of the study. An external clinical Project Manager can coordinate the study as a whole, complement the sponsor’s existing team or take responsibility for selected activities where additional capacity or expertise is needed.

What does a clinical Project Manager do?

A clinical Project Manager coordinates the activities, timelines and stakeholders involved in a clinical trial. Depending on the scope, this can cover the full study lifecycle from planning and study start-up to study conduct, close-out and reporting.

The Project Manager helps ensure that agreed activities are followed up, timelines are monitored, documentation is maintained and communication between the sponsor, study sites, vendors and other parties works effectively.

Responsibilities can include:

• overall study and project management, including planning, coordination, timelines and follow-up
• regulatory and ethics submissions
• preparation and review of study documentation, including informed consent forms
• preparation and review of study-specific plans, such as monitoring, data management and safety plans
• preparation and review of study protocols and clinical investigation plans
• study start-up and coordination with investigational sites
• review of study files and documentation to identify gaps
• site, study team and vendor coordination
• management of documentation, changes and issues during study conduct
• study close-out, reporting and archiving activities.

When should you consider external clinical project management support?

External project management can be useful when the sponsor has the necessary internal expertise but needs additional capacity, as well as when specific clinical research expertise is missing internally.

Typical situations include:

• limited internal resources during study start-up or another busy phase
• studies involving several sites, countries, vendors or other stakeholders
• a temporary gap in internal project management resources
• a need for support with regulatory or ethics submissions, study documentation or study-specific plans
• a need for experienced coordination across different study functions
• a study or individual activity that requires additional follow-up to stay on schedule.

External support can also be considered when the sponsor prefers one experienced party to take broader responsibility for coordinating the study.

Do you need to outsource the whole clinical study?

No. Clinical project management can be outsourced at different levels depending on the sponsor’s resources and the needs of the study.

An external Project Manager can coordinate the entire project, complement an existing study team or take responsibility for clearly defined activities. For example, support may be limited to preparing an informed consent form, coordinating a submission, developing a study-specific plan, reviewing study files, coordinating sites or vendors, or supporting study close-out.

This allows the sponsor to retain activities that are best managed internally while adding external resources or expertise where they provide the most value.

What should be agreed when outsourcing clinical project management?

A clear division of responsibilities is important, particularly when activities are shared between the sponsor, a CRO and other service providers.

Before the project starts, the parties should define the scope of the assignment, roles and responsibilities, deliverables, timelines and communication practices. It should also be clear who is responsible for documentation and filing, coordination with sites and vendors, and escalation of issues and changes.

Defining these responsibilities from the beginning helps avoid gaps and overlapping responsibilities during the study.

What types of clinical trials can Medfiles support?

Medfiles provides clinical project management as part of clinical trials for medicinal products, medical devices and IVDs, and food products. With a strong presence in Finland, the Nordic countries and the Baltics, we can support both local and multinational clinical projects. Support can cover individual activities or the full study lifecycle, from study planning and regulatory and ethics submissions to study conduct, monitoring, close-out and reporting.

For medical devices and IVDs, Medfiles supports clinical investigations and performance studies and has expertise in the applicable regulatory and GCP requirements, including ISO 14155 and ISO 20916. For food products, clinical studies can support areas such as health claim and novel food applications.

Whether you need support for one specific task or throughout the entire study, our goal is to make your clinical project easier to manage and help your team focus on moving the study forward. Contact our clinical team to discuss the appropriate scope for your project.

Author:
Tea Koskela, Project Manager, Medfiles

Tea brings more than 30 years of experience in clinical trials across site and project management, team leadership and quality assurance. Her experience includes early-phase clinical trials, such as Phase I and II studies, as well as paediatric studies.

Tea’s background as a B.Sc. (RN) gives her a practical understanding of how hospitals and investigation sites operate and how site staff work in their daily environment. She is experienced with Risk-Based Quality Management (RBQM) and enjoys helping clients identify practical ways to apply risk-based approaches to their individual projects.

For her, successful project management means understanding that every study and every client is different, adapting the approach accordingly, and ensuring efficient and prompt action throughout the project.

See also:

• Meet our people: from study planning to reporting – 20 years of experience in clinical research and scientific writing
• Meet our people: CRA ensuring success of clinical trials
• Medfiles contributes to advancing clinical research in Finland through FINCRO