fme CROAssist™  


About CROAssist™ 

fme CROAssist™ is a fusion of expertise and technology built to redefine the landscape of Trial Master File (TMF) management in clinical trials. This forward thinking partnership between fme and Just in Time GCP (JiT) combines the experience in both risk-based TMF management and seamless data migration solutions to enable the automated error-free transfer of CRO trial data to sponsor organization systems like Veeva Vault eTMF.

CROAssist is an automated solution addressing the most common pain points of TMF management, such as data integrity, standardization, and compliance with regulatory standards. With sophisticated algorithms and artificial intelligence that enhance data integrity and compliance, CROAssist minimizes human intervention, significantly reducing the risk of errors and inconsistencies ensuring the TMF is always audit-ready. These advanced technologies enable a proactive approach to TMF management, identifying potential issues before they become significant problems. Download the datasheet now for full details, and contact us for a demo today.

Target Group

  • Clinical Information Managers
  • Contract Research Organizations
  • Research Sponsor Organizations


  • Life Sciences


    • Inspection Ready TMF: Streamlined TMF Strategy that ensures standardization across portfolios and the agility to respond to changes in the regulatory landscape.
    • Strengthened Partnerships: Clear governance structure and engagement model that empowers long-term strategic partnerships.
    • Business Impact Reduction: CROAssist significantly reduces the operational burden on businesses by managing complex TMF processes.
    • Efficient Data Flow Management: Seamlessly manages data flow between sponsors and their CROs, ensuring smooth communication and coordination.
    • Validated Data Integration: Provides validated data importation into Veeva Vault eTMF solutions, enhancing data integrity and reliability.
    • Streamlined Operations: Simplifies TMF management, allowing businesses to focus on core activities.


    Contact Us

    Don't like forms? Contact us directly to get more details on any of fme's services. We'd love to discuss your current challenges, and how fme can help you get the highest ROI and lowest TCO for your technology solutions. Call or use my personal contact form with your question, and I'll get you connected with the right fme expert.

    fme is always looking for top talent to join our team. If you are looking to join the team you'll love to work with, review our job listings and review the details of current openings. Contact me if you have any questions on the application process.

    Tracey King
    Technology Success Manager