Successful execution of a rescue trial

CASE STUDY 3


CHALLENGE/S

One of our Sponsors had initiated a multi-country study across the world across 25 sites across the USA, Mexico, Australia, and the APA region with a leading global CRO but was not able to complete the enrolment procedure in more than a year and approached CBCC for this rescue trial.

• Adopting Global protocol and accommodating Indian regulatory requirements

• Coordinating with master CRO, independent IP depot, independent data management provider, independent vendors for
shipment of ancillary materials for the study, central lab of the CRO, independent vendors for shipment of PK
samples and bioanalytical sites

• Complex sample processing techniques

OUR STRATEGY

• Specialized, trained workforce and a robust project plan was deployed to implement micro-level approach in meeting regulatory requirements, enrolment targets and achieving critical study milestones.

• Multiple investigative sites were evaluated and carefully selected based on their patient database and their expertise in handling complex oncology products.

• Close coordination with sites and other stakeholders globally, to meet recruitment targets and to ensure efficient conduction of study, considering the safety aspects of the cytotoxic molecule.

• We completed the enrolment of 30 patients in just 3 months from 8 sites.

• Skilled and trained phlebotomists were identified, trained and deployed at all investigative sites to handle complex sample processing and to ensure sample integrity.

VALUE

We blended our operational skills and quality to deliver high-quality data on time. CBCC has handled complex sample preparation techniques without affecting the sample integrity in a PK end-point study by adhering to applicable regulatory requirements and thus, received positive feedback from the sponsor. This rescue study not only helped our sponsor in achieving their study timelines but it also laid the foundation for a very strong partnership between CBCC and the sponsor. Currently, CBCC is executing various studies for multiple offices of the sponsor for USFDA, EMA & ANVISA submissions.

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