The Trial Master File (TMF) is a central repository of documents that houses crucial records collected by clinical trial sponsors, investigators, and contract research organizations (CROs) throughout the lifecycle of a trial. A TMF enables a clinical trial to be fully and accurately reconstructed for regulatory inspection purposes, providing evidence that all involved stakeholders have ensured participant safety, were compliant with local and international regulations, followed Good Clinical Practice (GCP) guidelines, and produced scientifically robust benefit-risk data. Maintaining the highest quality within the TMF is crucial for sponsors and CROs to ensure regulatory submission integrity. Although ICH E6 Section 8 provides the minimum essential documents to keep on file during each phase of a clinical trial, most TMFs will accumulate several more documents, datasets, and data outside the definitions listed in Section 8. Learn more about the Trial Master File (TMF) in our article here!

Because tracking all these records can quickly become plagued with issues around inefficient oversight, incomplete files, and extraneous documentation, sponsors are increasingly outsourcing TMF management to CROs. Therefore, a meticulously maintained TMF is crucial during the drug development process because it can significantly expedite a product’s regulatory review timeline, potentially helping treatments reach the market faster. Recognizing this, TFS HealthScience, a leading global CRO, offers comprehensive TMF services designed to streamline this process and ensure the integrity of clinical trial documentation from start to finish.

In this article, we provide an overview of TFS’s CRO services and TMF capabilities, highlighting how sponsors can benefit from these services to optimize trial oversight. Read on to learn more!  

 

Overview of TFS CRO and Its Services

Since its founding in 1996 out of Lund, Sweden, TFS HealthScience CRO has become an established mid-size CRO with a global presence across more than 20 countries. The company specializes in offering full-service, functional-based, and strategic resourcing for biotech and pharma clients across numerous key therapeutic areas, including Dermatology, Internal Medicine, Neuroscience, Oncology, and Ophthalmology. These operations are guided by TFS CRO’s five core values to ensure they consistently deliver high-quality services: Trust, quality, flexibility, passion, and sustainability.

TFS CRO leverages a global network of investigator sites, technology partnerships, data collaborations, and key opinion leaders (KOLs) to offer comprehensive services in three primary areas:  

1. Clinical development services: Covers early- to late-stage clinical trials, supporting project management, regulatory start-up, clinical monitoring, drug safety and pharmacovigilance, and medical writing, among many other services. Click here to learn more.  

2. Strategic resourcing solutions (SRS): Covers short- and long-term solutions for strategic resourcing, as well as recruitment services for permanent hire, with extensive global expertise, benefitting sponsors and other CROs. Click here to learn more. Visit our article on Strategic Resourcing Solutions (SRS) here and learn more about TFS’s expertise in this area! 

3. Functional services: Provides fit-for-purpose functional service provider (FSP) outsourcing solutions uniquely tailored to each customer’s needs with a fully integrated and dedicated team to offer enhanced quality, flexibility, and sustained efficiencies. Click here to learn more. Read about functional service providers (FSP) here and TFS’s modern approach to FSP. 

 

TFS CRO: A Leading Partner in Trial Master File (TMF) Services

In addition to these offerings, TFS CRO provides extensive TMF services and trained TMF delivery teams for clinical trial sponsors, emphasizing the importance of centralized, secure systems for document storage. Recognizing the limitations of paper-based TMF management, TFS relies on the Veeva Vault electronic TMF (eTMF) platform to streamline document storage and management within clinical trials. Within this ecosystem, the lifecycle of an eTMF document undergoes several quality control stages to ensure inspection readiness and preparation for audits.  

The first round of quality control (QC1) of the eTMF document lifecycle requires the document owner and uploader to achieve 100% quality control before uploading into the eTMF. Next, during the second quality control round (QC2), the document reviewer carries out 100% quality control by confirming whether the document meets all requirements and is ready for an audit or inspection. At the QC3 stage, functional line representatives are responsible for 10% quality control of approved documents to check QC1 and QC2 effectiveness before summarizing their findings in the QC3 Report. Throughout all three of these stages, a continuous reconciliation process takes place to identify missing documents and cross-check against filed documents within the TMF.

Recognizing the importance of meticulous and timely TMF document submissions, TFS CRO strictly adheres to established timelines and specified periods for uploading files into the Veeva eTMF.  

• Green Light (GL) Documents: Uploaded within seven calendar days after document finalization/collection. 

• Site-Level Documents: Uploaded within 14 calendar days after a site monitoring visit. 

• All Other Documents: Uploaded within 30 calendar days after document finalization/collection. 

 

Following thorough quality control checks, documents are added into the eTMF once they are considered inspection-ready, which results in the Veeva eTMF system updating all associated TMF quality control metrics and key performance indicators (KPIs). These features are accessible on an ongoing basis for sponsors, CROs, and other stakeholders to encourage continuous data sharing and eTMF oversight. The Veeva Vault system used by TFS also requires regular monthly TMF status reports to be submitted in a timely manner by a designated team lead to ensure more successful oversight. 

 

Top Benefits of Using TFS HealthScience’s TMF Services

Using TFS’s TMF services offers several benefits, including improved inspection readiness, greater visibility and control over document storage and retrieval, and enhanced oversight processes. With the use of the Veeva Vault eTMF platform, TMF outsourcing to TFS ensures that all documents are easily accessible and up-to-date, reducing the likelihood of misplacing or duplicating documents. Sponsors also benefit from TFS’s adherence to strict timelines and quality control stages, which promotes better compliance and inspection readiness. Their ongoing access to this information and other TMF quality control metrics and KPIs, along with regular eTMF status reports, further enhances the efficiency of TMF management processes.

Another significant advantage of outsourcing TMF management to CROs like TFS for sponsors is gaining access to advanced technology and automated systems like those in Veeva Vault, as well as expert TMF delivery teams that are already trained and familiar with the platform. Rather than rely on inefficient traditional paper-based approaches to TMF maintenance, TFS’s eTMF capabilities include automated submission reminders and alerts, regular check-in meetings, and proactive adherence trackers. All these features offered by TFS’s TMF services help ensure more accurate and higher quality document repositories for sponsors, while encouraging a team-based approach with ongoing, clear communication between all key stakeholders. 

 

Ensuring Adequate Sponsor Oversight with TMF Outsourcing to TFS CRO

Most importantly, outsourcing TMF management to a qualified CRO like TFS allows sponsors to focus on other critical aspects of clinical trials, such as candidate research and development to drive future innovations. However, it should be noted that sponsors are still required by ICH GCP guidelines to maintain continuous oversight of the trial, including any additional duties subcontracted to another party by the sponsor’s contracted CRO, such as TMF services. Remaining compliant with these guidelines may involve implementing best practices such as establishing clear standard operating procedures (SOPs), utilizing automated systems, fostering transparency, and regularly reviewing KPIs.

Although, throughout the oversight process, sponsors must strive to maintain the right balance when outsourcing to CROs, where compliance can be monitored without stifling the CRO and keeping them from performing their tasks effectively. Some strategies to achieve this balance could entail conducting regular audits of eTMF systems, establishing clear communication channels, and adopting a collaborative approach to problem-solving when issues arise.  

 

Conclusion

In conclusion, TFS’s TMF services are essential for strengthening the quality of a sponsor’s oversight over their outsourced TMF, contributing to the overall success of clinical trials. Specifically, the company stands out for its use of centralized, secure document storage systems, as well as monitoring and adhering to strict timelines for document submissions and quality control stages. With the help of TFS’s experienced TMF delivery teams, sponsors can benefit from stricter regulatory compliance, improved inspection readiness, greater visibility and control over documents, and enhanced oversight processes. Through their dedication to high-quality services, advanced technology, and comprehensive oversight processes, TFS CRO stands as a reliable partner in the clinical development journey, helping bring your new treatments to market more efficiently and ethically. 

 

About TMF Services at TFS HealthScience CRO

TFS HealthScience is a global CRO specializing in clinical trial management, including Trial Master File (TMF) oversight and management. Under the strong leadership provided by Monika Baś (Ph.D.), head of TMF Delivery at TFS, and Victoria Hornagold, VP of TFS Clinical Development Services, our TMF delivery team collaborates closely with sponsors to ensure compliance and efficiency in TMF processes throughout the clinical development process.

By building solution-driven teams, we help maintain high standards of regulatory submission integrity and inspection readiness with strategies tailored to your unique needs.

Visit our website to learn more about the solutions TFS can offer for your next clinical trial, or connect with a TFS representative today!