As more and more companies choose to implement eTMF solutions to support their trial master file management, it becomes increasingly evident that Sponsors need to ensure that the solution - technology, processes, and operating model - supports not just internal stakeholders but also their CRO partners.
Paragon has worked with numerous clients to implement eTMF solutions and we have the following tips on how you can make sure that CROs and CRO-run studies fit into your Trial Master File Management strategy.
First and foremost you need to decide how CROs will interact with your system. In order to do this you need to understand what is currently happening in terms of TMF management and how you desire this to change.
Assess and understand what your CRO models are currently. Do you fully outsource your trials to CROs or do you also manage some trials internally? For outsourced studies, which eTMF systems do your CROs use?
Define the options for future state operating models (CRO working directly in your eTMF; CRO content transferred to eTMF via direct transfer from their eTMF system to your eTMF system; or CRO works in their system and transfer to sponsor at the end) and rank your internal preferences.
Meet with CROs to review the impacts/outcomes of the different models to determine any other hidden areas of impact..
Engage with CROs to evaluate the change impact to their current working model and target options that minimize any duplicative activities, provide the CRO with the documentation they require at study close, provide maximum opportunity for oversight and minimum cost increase.
Review and understand current contracts and MSAs and evaluate most recent performance in meeting expectations.
Document and get agreement on the CROs around which operating model each CRO partner will leverage.
In order to support the operating model and maximize efficiency you need to reduce the amount of manual work that occurs around TMF management. This requires an understanding of the eClinical systems that are involved in TMF management at both the CRO and Sponsor.
Identify all current data/document flows between CRO and Sponsor systems – CTMS feeds, trip report systems, safety databases, IP management.
Determine the impact to the existing integrations (if you are moving from a legacy eTMF to a new solution)
Determine which flows can/should be automated and which will require manual transfers
If early in the eTMF development process, invite the CRO to contribute input on the development of the structure and ensure mapping between any existing CRO TMF structure and your planned TMF architecture
Treat CRO stakeholders as core users of the solution to ensure that they are willing/able to use the tool.
Include CROs within change management activities to drive adoption.
Ensure the CROs have appropriate training and support to work in the planned model.
Ongoing governance and oversight are necessary to ensure that the solution continues to provide value and that continuous improvement occurs.
Create a governance structure that includes both Sponsor and CRO stakeholders to ensure collaboration
Provide the CROs with the opportunity to contribute ideas for enhancements and provide incentives via engagement and transparency to the system management and evolution.
Leverage KPIs and reports to guide CRO oversight
If you follow the above tips, your eTMF initiative has a great chance of successfully incorporating CROs and helping to ensure that all studies - regardless of ownership - are inspection ready.
Connect with me on
Chris McSpiritt is the Clinical Practice Lead for Paragon’s Life Science Research& Development team. Chris has over 10 years of pharmaceutical industry experience in R&D and has applied his business architecture, business process management, and analytical skills to help pharmaceutical companies improve the conduct of clinical trials for global life sciences companies. Chris holds a BA in Psychology from the University of Notre Dame. He is an active member of the Business Architecture Guild, Association of Business Process Management Professionals, Project Management Institute, and Drug Information Association.