Case Study

Achieving Breakthrough Therapy Designation Accelerates Oncology Treatment Development


In pursuit of PRIME eligibility by the EMA and breakthrough therapy designation by the FDA for their groundbreaking multiple myeloma treatment, a biopharmaceutical company faced the urgent need to expedite their Phase 1 trial.

See how a fully integrated and unified platform solution, including EDC and RTSM, was implemented two weeks faster than the proposed timeline, while taking into account all the study needs, including scientific expertise, custom workflows, and real-time analytics to achieve the following:

  1. Leverage the unified platform's Configurable Designer in collaboration with a CAR-T experienced project team to ensure the delivery of the solution ahead of schedule.
  2. Furnish robust analytics dashboards to track study trends and facilitate continuous medical and statistical monitoring of the study data.
  3. Drive clean data and a timely database lock.

For additional insights and more information about the rapid setup for the oncology trial, access the case study provided below.

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