We are familiar with the large CROs like ICON, PPD, Quintiles, Parexel, and Covance but the smaller CROs are catching the attention of more small Biotech companies and in some cases even big Pharma because of lack of sufficient resources at big Pharma. Life Science Companies are relying on the expertise/staffing that CROs can provide, as well as the collaborative team mindedness of the small CROs and their nimbleness. However, the large CROs will argue that they are customer service focused as much as their smaller colleagues are. Other areas that are causing an increase in the utilization of CROs are Sponsors need for global service which the large CROs can provide, the use of Electronic Data Capture (EDC) systems which most CROs (large & small) are embracing, safety monitoring, early development/ proof of mechanism expertise and most recently biomarker research expertise.
The current trend is for CROs to truly partner with Sponsors in an effort to deliver quality including data quality, clinical development expertise, effective management of the clinical team at the CRO, regulatory guidance and safety monitoring. It will be critical for CROs not to look at partnerships only as a Preferred Vendor opportunity but they should look at Partnership as an opportunity to be involved in the drug development process/strategy, developing an understanding of the company culture (Sponsor), effectively collaborating with the clinical team at the Sponsor site, as well as assisting in problem solving and sharing in both successes and risks.
We have all heard about the disadvantages of using a CRO such as high expense, high staff turnover, insufficient expertise, ineffective communication and lack of quality. However, as Sponsors rely more on CROs it will be important for Sponsors to lead by example, collaborate and turn disadvantages into potential advantages particularly since the FDA is now holding both the CRO and Sponsor accountable. That being the case, pointing the finger at each other will no longer work.
As the use of CROs increase there are a few things that should be considered to make your experience a successful one.
- Develop a strategy (short & long-term); for example, selection criteria, therapeutic area expertise, operating environment/culture, audit plan, communication plan, define roles and responsibilities, as well as clearly communicating expectations
- Perform detailed training beyond the IB, protocol and CFR completion
- Tie payments to milestones
- Attached penalty/bonus structure to timeline misses and successes
- Developed a strategic collaborative relationship with the Project Director
- Hold weekly status meetings(teleconferences) with appropriate individuals as defined by the agenda
- Hold at least twice a year face to face meetings