Case Study
Streamlining Safety Review for Immunotherapy Trial through Real-time Data Access & Flexible Study Build
Project Background Our client is a recently launched, venture-backed biotechnology company developing immunotherapies for oncology, infectious diseases, and immune disorders. The company uses its proprietary platform to develop novel and effective therapies that overcome typical challenges with immunotherapies and meet unmet patient needs.
The Challenge Our client planned a phase 1 dose escalation and expansion study investigating safety and PK/PD (pharmacokinetics and pharmacodynamics) for an immunotherapy treating advanced solid tumors. They chose to partner with eClinical Solutions as their biometrics services provider and benefit from the capabilities of the elluminate platform to accommodate the complex data collection requirements for the study. The services encompassed clinical data acquisition, clinical data management, and statistical programming. As part of this delivery, our client sought a solution to support their pharmacovigilance processing and serious adverse event (SAE) reporting requirements. They were keen to leverage the study’s existing technologies—Medidata Rave and elluminate—to fulfill the requirements. SAEs must usually be reported within 24 hours or less, to the appropriate regulatory authorities, institutional review boards (IRBs), ethics committees, and the sponsor. Therefore, ensuring real-time data access was crucial to assure patient safety and timely interventions, early signal detection and insight into emerging patterns of adverse events, and accurate reporting and detailed documentation of events.
Company Profile ■ Emerging biotechnology company ■ Headquartered in United States ■ Approx. 30 employees
Products Utilized Biometrics Services elluminate Clinical Data Cloud