PK study with challenging indication

CASE STUDY 2


CHALLENGE/S

A US-based speciality pharmaceutical company wanted to conduct a PK endpoint study for one of the antiandrogen molecule and to file the ANDA application to the USFDA. For the study, 40 patients with metastatic prostate cancer were supposed to be enrolled. Multiple CROs had initiated the PK study with the same molecule but none of them succeeded to complete the study considering complex study design, patient population and other enrolment challenges.

OUR STRATEGY

• CBCC engaged expert oncologists from CBCC’s hospital centres in the US for protocol designing to maximize opportunities for patient enrolment ensuring regulatory compliance.

• Our team had performed real time feasibility across its speciality network sites in India and identified potential sites for the study with required patient pool.

• CBCC deployed experienced team of PM & CRAs having good therapeutic knowledge, to execute this challenging project as per sponsor expectations.

• Our team prepared innovative patient recruitment and retention strategies and motivated selected Investigators to implement those plans at site level.

• Experienced phlebotomists were sent to each site to handle PK sample collection and processing activities.

VALUES

With our strong understanding of the therapeutic domain and >30 years of experience in Oncology, we were able to scientifically design the study to maximize patient enrolment. Real time feasibility performed at network sites, excellent project planning, execution and real time monitoring of key deliverables on monthly basis helped us achieve this challenging task. CBCC has successfully completed the patient enrolment within estimated timelines.

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