Optimizing Clinical Trial Management: Specialized Operational Management Services Through an FSP

By Rich D’Amato, Actalent Data Science Expert | September 29, 2025

Read how working with an FSP partner can help facilitate streamlined operations and trial success by providing a range of support across critical clinical trial management areas.

Clinical trials demand precision, compliance and efficiency to deliver high-quality data on time and within budget. Functional Service Providers (FSP) integrate specialized functional resourcing support through project-based, full functional outsourcing or hybrid-based models — offering researchers tailored solutions to manage complex administrative tasks that are critical to making clinical trial management run efficiently.

This article will explore how working with an FSP partner can help facilitate streamlined operations and trial success by providing a range of support across critical clinical trial management areas.

Expertise and Support for Learning Management Systems (LMS) Management

Having trained personnel supporting all phases of your clinical trial is critical to them being effective and reliant. Effective training ensures clinical trial teams meet compliance and proficiency standards. FSP partners can provide specialized functional resources to help manage your LMS platforms, track training completion for Good Clinical Practice (GCP) and much more across to ensure your teams have the learning and training support they need. These resources can also help maintain accurate records, monitor progress and generate compliance reports, reducing audit risks and ensuring all team members complete the required training needed to maintain trial integrity.

Specialized Trainers and Mentors to Support Your Teams

Trainers and mentors provide hands-on guidance for internal and external teams, building expertise in data management tasks like Electronic Data Capture (EDC) systems, edit check development, team lead responsibilities, DM listings, and standardized datasets (e.g., SDTM, ADaM) or tables, listings and figures (TLFs). Through tailored workshops and ongoing mentorship, enhance team skills, improving data quality and operational efficiency.

KPI/Dashboard Development and Maintenance

Integrated resources provided through an FSP model can be critical assets to help provide ongoing data and reports. Depending on your preference for reporting timeframes, they can design and maintain KPI dashboards for real-time trial insights, delivering monthly, quarterly and year-to-date (YTD) reports. These dashboards are critical for tracking key metrics like site performance, data quality or enrollment rates, enabling proactive decision-making throughout your clinical trial operations. For instance, a dashboard might flag delays in data review, prompting swift action. Regular maintenance of these KPI dashboards also helps optimize overall clinical trial management, ensuring data accuracy and relevance across the entire trial life cycle.

Corrective and Preventive Action Management

Corrective and Preventive Action (CAPA) systems are vital for addressing non-compliance and preventing future issues. FSP resources can oversee CAPA processes for data management and biometrics, developing action plans, tracking progress and generating monthly, quarterly and YTD reports. These steps can ultimately help ensure timely resolution and compliance with ICH-GCP standards, mitigate risks and maintain trial quality.

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Timeline Development, Oversight and Maintenance

Coordinators create and manage detailed trial timelines, aligning cross-functional teams and monitoring milestones. They also help identify potential delays and can adjust schedules as needed to keep projects on track. For example, in a global trial, by coordinating data submission deadlines across 100 sites, these resources can help ensure regulatory compliance and timely deliverables.

Trial Master File Management

Trial Master File (TMF) is the cornerstone of trial documentation. Having the right specialized resources can help you manage document collection, organization and quality control within electronic TMF (eTMF) systems. Additionally, using tools like AI for document classification, these specialized FSP resources ensure completeness and accessibility, creating a comprehensive trial record that supports regulatory compliance.

Independent TMF Inspection Readiness and Compliance

In any trial, it’s important to conduct independent TMF audits to ensure inspection readiness for agencies like the FDA or EMA. FSP resources can help review document completeness, metadata accuracy and adherence to the TMF Reference Model and subsequently develop related standard operating procedures (SOPs) and perform gap analyses to prevent inspection findings and ensure trials withstand regulatory scrutiny.

Creation of Comprehensive Patient Profiles

Comprehensive patient profiles provide a detailed and holistic view of individual patient data, crucial for medical monitors and submissions. The application integrates datasets (e.g., Adverse Events) to generate customizable profiles that can be leveraged by medical monitors to power their decisions and stay ahead of safety concerns. These profiles can be used for real-time safety monitoring or regulatory submissions, enabling rapid identification of protocol deviations or safety concerns. The on-demand generation enhances clinical oversight and compliance.

Effective Auditing Processes and SOPs

Clinical trials demand rigorous adherence to processes and SOPs to meet regulatory standards, such as those set by the FDA or EMA. Experienced FSPs can help deliver specialized audit support, ensuring compliance across key administrative functions.

How Actalent Can Help Optimize Your Clinical Trial Management

Working with the right FSP — particularly with one that can provide highly skilled integrated FTEs and functional resources — can transform your clinical trial management.

As a trusted partner with experience supporting development operations, Actalent aims to be your preferred FSP partner for your embedded and outsourced needs. We are a global FSP clinical development services organization that offers a wide range of services through our product-based, full functional outsourcing and hybrid-based FSP delivery models. We’re ready to deliver specialized support across your clinical trial operations in areas including LMS tracking, training, KPI dashboards, CAPA management, timeline oversight, TMF management and audits. We’ll help ensure compliance, enhance data quality and accelerate timelines for your trial, empowering sponsors and CROs to focus on advancing patient outcomes and your trial to be a success.

Frequently Asked Questions About Specialized Operational Management Services for Clinical Trials

What are Actalent’s FSP models for clinical trial administration?

Actalent’s FSP models include specialized functional resourcing support delivered through project-based, full functional outsourcing or hybrid-based delivery models. Integrated functional resources are dedicated professionals embedded in your team for ongoing support, unit-based focuses on specific deliverables (e.g., KPI reports) and T&M provides on-demand expertise for tasks like TMF audits.

How do functional resources manage trial timelines?

Coordinators develop, oversee and maintain trial timelines, aligning cross-functional teams and monitoring milestones. They proactively identify and address potential delays to keep projects on track and meet regulatory and sponsor expectations.

What is involved for trainers or mentors?

Trainers and mentors deliver tailored training on data management and biometrics tasks, including EDC navigation, edit check development, team lead roles, DM listings, and creation of SDTM, ADaM and TLFs. They offer workshops and ongoing mentorship to enhance team skills and data quality.