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Why Sponsors and CROs Should Break Up with Their Trackers for Trial Management

Michael Smyth, Division President

Trial Management

Wednesday, November 8, 2023 | 10:03 AM

broken heart image

15 business cases to motivate your organization to shift from antiquated Excel trackers to a comprehensive eClinical Platform. 
 

If you're still relying on Excel trackers, rest assured, you're not alone - you can find them in every sponsor and CRO conducting clinical development. But as technology advances and regulatory scrutiny intensifies, a growing number of companies are starting to transition from Excel trackers to a holistic eClinical platform. With benefits like enhanced real-time access, robust security, and superior filtering capabilities, it's time to consider “breaking up” with your traditional trackers and embracing the next generation of eClinical software solutions. 

 

  • Study Start Up through Site Activation Most sponsors and CROs employ various trackers to supervise the study start-up process. By transitioning from multiple disjointed trackers—whether Excel or paper-based—to an integrated eClinical Platform, you can centralize all study-related data in one repository. This consolidation reduces email overload resulting from CROs and Study Vendors utilizing individual trackers. Beyond simplifying communication, a comprehensive eClinical Platform grants real-time access, enabling study personnel to retrieve status updates on studies and sites without awaiting CRO updates. Additionally, this platform lightens the load for sites by supporting multiple languages^1

 

  • eFeasibility A well-rounded eClinical platform, like Trial Interactive, centralizes site data in real-time. With features like feasibility status tracking, advanced feasibility weighting and analysis, and summary information bar graphs, users can make more informed site inclusion decisions. This accelerates site selection and shortens the time to study commencement. 

 

  • Budgets and Contracts Modern eClinical systems facilitate collaboration on budgets and contracts. By eschewing spreadsheets, you can maintain version control. Alongside a secure environment, data protection, and configurable access permissions based on roles, platforms like Trial Interactive ensure budget formulation is both secure and efficient. 

 

  • Protocol Deviations Excel trackers, apart from being non-compliant with 21 CFR part 11, cannot provide instant status updates. You require immediate access to status updates, actions taken, owners of each protocol deviation as well as especially concerning protocol deviations. With Trial Interactive, users can verify the status as well as availability of source documentation for specific deviations (when required) and access all site-specific as well as study deviations. The system even enables direct document submission to medical monitors, ensuring compliance and readiness for regulatory inspections^2

 

  • Milestones Study coordinators benefit from real-time monitoring of active and upcoming milestones. An integrated CTMS, detailing milestones like patient enrollment numbers, helps pinpoint bottlenecks and strategize to avert future timeline delays. Users can also customize filters based on specific parameters, including excluding completed milestones. 

 

  • Site Contacts Managing contracts across multiple vendors, like IRB, EDC, and ePRO, can be challenging. A holistic eClinical system centralizes all vendor and partner contracts, encompassing site and budget agreements. This centralization enhances security and accuracy through version control. 

 

  • Site Visit Monitoring Modern eClinical platforms maintain records of compliant Part 11 visits. Users can easily filter data across multiple sites, a far cry from sifting through multiple trackers. Mobile-enabled platforms, like Trial Interactive, let users schedule visits and generate site visit report documentation on-the-go, in any language. Study and Project Managers have a holistic calendar view of planned and completed site visits. QA team can access real-time audit trails—capabilities far beyond paper or Excel trackers. 

 

  • Site List Tracking multiple sites with ever-changing site contacts and addresses, IRB/EC approvals/renewals and approved versions of ICFs can be daunting with Excel. A comprehensive eClinical platform manages such complexities effortlessly. 

 

  • Trial Resourcing Tracking study resources using Excel often involves multiple files. An eClinical platform consolidates all this data, allowing users to view projections, manage staff, and allocate resources efficiently. Cross-study reports also facilitate resource management as funding scenarios evolve. 

 

  • Investigator Database eFeasibility surveys on platforms like Trial Interactive  dramatically reduce study start-up timelines. Users can filter site results based on numerous parameters, simplifying the site selection process. 

 

  • Training / LMS Tracker Transitioning to a comprehensive learning management system enhances training outcomes for study and site personnel and assures protocol compliance. Features like auto-enrollment in eLearning courses and training reminders make learning more flexible and compliant all in a 21 CFR Part 11 compliant platform as required by FDA.

 

  • IP Accountability FDA guidelines classify new compounds and devices as Investigational products. A comprehensive eClinical platform ensures proper records are kept for IP accountability to meet these guidelines including distribution of product lot number, IP accountability, and all reconciliation a CRA needs to do for each site with study patients. 

 

  • eTMF QC and Completeness: Using an eTMF as part of a larger SaaS eClinical platform such as Trial Interactive eTMF provides numerous advantages over traditional systems. Beyond document storage, it offers a holistic document management solution, tailored for clinical, quality, and regulatory documentation to stay Inspection ready at all times. 

 

  • Study Team Lists: A comprehensive eClinical platform simplifies the task of maintaining team lists, offering real-time updates on resourcing allocations and preventing disruptions due to personnel turnover.

 

  • Subject Tracker: Like tracking study team personnel, monitoring subjects using traditional methods can be tedious. An eClinical platform centralizes data, allowing you to quickly view enrollment and subject status within a study, improves security, and enhances scalability. 

 

By embracing the capabilities of a comprehensive eClinical platform, sponsors and CROs can streamline operations, ensure compliance, and optimize clinical trial outcomes^3…and you and your company can finally break up with your trackers…for the last time.

 
 

References

 

  • [2] McKinsey & Company. (2023). Getting strategic about new product submissions in the pharma industry. Retrieved from McKinsey & Company. 

 

  • [3] Gartner, Inc. (2023). Hype Cycle for Life Science Research and Development, 2023. Retrieved from Gartner, Inc. 

 

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