PCRT provides a central resource biotech and pharma companies seeking strategies and clinical resources. Our comprehensive approach to clinical trial design and implementation includes:
* Design and conduct of preclinical studies through TGen Drug Development (TD2)
* Strategic design of clinical protocols—the PCRT members provide input on the study design for feasibility, effectiveness, and overall strategy for drug development.
* Strong relationships with PCRT Investigators in the network—the PCRT Project Managers have developed strong relationships with the PCRT Investigators that enables the studies to open faster and run more smoothly at the respective institutions.
* To engage in the planning and coordinating all aspects of clinical trials, including (but not limited to):
- the preparation of protocols
- CRO selection
- specific and rapid selection of premiere clinical research sites from the PCRT network including providing immediate feasibility information
- centralized IRB oversight for participating PCRT sites
- centralized regulatory documentation collection
- Initial and/or complete budget and contract negotiation on behalf of the sponsor
- Increased and more efficient communication among the PCRT sites and the Project Managers to ensure timely, accurate and complete submission of study data throughout the trial
- Payment administration of the study budgets to PCRT sites if requested
The Serum and DNA Bank
A central feature of the PCRT approach is the collection and analysis of serum and DNA (The Serum and DNA Bank) from hundreds of pancreatic cancer patients throughout the world. Currently, there is no such resource available for investigators in the field of pancreatic cancer. The discovery of biomarkers to predict early recurrence of macroscopic disease or recurrent disease could facilitate innovative therapies, when the likelihood of success is higher. This research database, which is available to interested researchers, allows for the in-depth analysis needed for rapid development of highly targeted therapies. Working collaboratively with PCRT provides researchers with unrivaled access to a worldwide network of clinically-annotated, prospectively consented biological materials from patients with pancreatic cancer.