Managing a Rigorous and Aggressive Clinical Trial Timeline

Global clinical trial

Managing a Rigorous and Aggressive Clinical Trial Timeline

The global clinical trial space can be difficult to navigate: Manufacturers must adhere to strict regulatory requirements during all phases of clinical trials — while still meeting important deadlines. In one recent example, a manufacturer asked UBC to provide data to support the Marketing Authorization Application for their new product. We worked with regulatory authorities in 13 countries across the globe, which included countries in North America, Asia, Europe and Australia.

The manufacturer was impressed with UBC’s worldwide experience, such as our understanding of country-specific regulatory requirements and important cultural differences. In addition, our flexible resource capacity management approach allowed us to commit to the client’s rigorous timeline and manage any challenges along the way.

Situation

The trial was a randomized, double-blind, Phase III oncology study and included 800 patients at 124 global sites. Our team’s extensive oncology experience and understanding of regional patterns of care allowed us to identify the right investigators in the right countries. UBC provided a full-service clinical trial offering, including:

  • Country and site start-up
  • Patient recruitment
  • Site monitoring and data verification
  • Project management
  • Data management
  • Clinical data review
  • Clinical medical review
  • Regulatory submissions and notifications
  • Pharmacovigilance services
  • Study close out
  • Japan Marketing Authorization Application assistance
  • Analysis and reporting for FDA and EMA regulatory filing

Unified Approach

UBC implemented a flexible resource strategy to manage the client’s aggressive and rigorous timeline.

  • Unified team

    • Collaborated cross-functionally among staff, physicians, the sponsor, and other vendors
    • Maintained positive relationships with the sites and physicians
  • Flexible resourcing

    • Increased the number of internal staff at times of peak workload
    • Scheduled more frequent site visits as required
  • Streamlined communication to meet the demands of rapid patient enrollment and data entry

    • CRAs followed up with the sites for transparency of timeline needs
    • CRAs worked hand-in-hand with sites to provide clarification and support them with data query resolution
    • Frequently updated all stakeholders on the progress of the trial’s activity and expedited action was taken where necessary

Exceeding Expectations

For many patients, this product is their last chance to fight an aggressive and advanced disease. The high interest and enthusiasm accelerated enrollment, which increased the flow of data to be verified, reviewed, and cleaned.

Our flexible resource capacity management approach allowed us to successfully manage the increased flow of data and increase timeline gains. We completed the database lock 3 months and 17 days ahead of schedule — significant time savings to the client. Our ability to work with the manufacturer as one team, collaborate cross-functionally, and maintain positive working relationships allowed us to deliver such an important milestone ahead of the client’s expected timeline and goals.

“Congratulations everyone for this great accomplishment! A great team effort between all departments to accomplish this important milestone!” -Sponsor representative

To learn more about how you can benefit from UBC’s robust Clinical Development offering, please contact us.

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