CRO Management
Trial Management Service achieves high data quality while reducing trial costs
Pharmaceutical companies and medical device organizations face increasing pressure on high drug costs and look for ways to lower prescription drug prices without losing profits. Sponsors can contract consulting services to acquire expertise without hiring permanent staff.
Although a trial sponsor may transfer all trial functions to a third-party CRO, the sponsor remains responsible for the data integrity and ensuring it is backed by good science.
The SCIOSM method allows for CRO management and efficient communication with senior management needing the new economy, patients, and shareholders’ needs.
BBCR provides biotech and pharmaceutical companies with the right expertise and resources tailored to support clinical development programs transitioning from preclinical into Phase II PoC studies and successfully delivering studies on time and within budget.
- CRO management
- medical/safety monitor
- regulatory affairs
- trial and program management
Case Study
Completing enrollment ahead of the timeline
Challenge: A phase 3 in a rare systemic disease started to be a USA study only. Treating physicians were mainly respiratory doctors, while the treatment target was gastroenterology. Patient enrollment was insufficient.
Solution: BBCR increased sites outside the USA. Evaluate EU and ROW sites’ interest, patient availability, and study feasibility based on regional diet. EU sites had a low number of competitive trials, treated both adult and adolescent patients, and had less diet variability than the USA sites, compared to ROW sites.
Result: Additional EU sites were engaged. These sites enrolled about 50% of the total number of patients. The enrollment ended one week earlier than initially planned.