Considerations When Selecting A CRO For Phase I Clinical Studies

Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies, including,

• Clinical, therapeutic, medical and regulatory experience
• Efficient processes and access to study participants
• An infrastructure and processes that mitigate risk
• Modern, efficient facilities.

This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

EXPERIENCE
One of the most important considerations in the CRO selection process is broad experience in Phase I trial execution. An organization with solid a track record of providing services from protocol design to final study reporting possesses the expertise to streamline execution. This can help sponsors shorten timelines for quicker go/no-go decisions.

Broad exposure to different types of studies, therapeutics and dosage forms are also pivotal in developing protocols to meet the varied needs of each sponsor. Creative and innovative study design for first in human, proof of concept, drug interaction, single ascending dose/multiple ascending dose (SAD/MAD) and cardiac safety studies are essential for ensuring safe and efficient study conduct.

Finally, a record of working with regulatory agencies world wide and significant experience filing clinical trial applications is critical to the successful completion of your study.

EXPEDITED PHASE I STUDIES
There are three contributing factors to a Company's ability to expedite Phase I studies

• The ability to rapidly recruit study participants,
• The capability to efficiently conduct clinical trials
• Rapid data collection and analysis tools