Clinical Research Organizations (CRO’s) across the country are partnering with biotech/pharma companies in greater numbers. It is important to note, that a significant portion of the R&D industry budget is spent on outsourcing services offered by the CRO industry. “The largest CROs, according to Industry Standard Research are Quintiles, Parexel, Covance, PPD, ICON, INC Research and inVentiv Health. Of course, there are a number of smaller CRO’s that are excellent and should be considered. To depend on the expertise of the CRO in drug – device development is probably the answer to many companies staffing concerns. However, the question that is often asked by senior management at the biotech/Pharma company is, how do we develop a positive professional relationship with the CRO and manage the relationship effectively? Let’s start with the fact that the CRO has the expertise in clinical drug-device development. You’ve decided on your partnership due to the CRO’s experience, performance, clients, cost of service and of course, the expertise of their staff. However, given the positive position you are in, brush fires will occur; be proactive in addressing those brush fires.
With regard to clinical trial management, the CRO feels very strongly that they should be the primary contact with the investigative sites. OK, but the sponsor should also develop a relationship with investigative staff during the course of the clinical trial so that they can follow-up on any issues voiced by the site staff. Developing that relationship can start by the sponsor holding a small roundtable meeting with the investigators and continue to build the relationship at the investigator meeting, site initiation visits, co-monitoring visits and meetings with the investigative staff outside of the routine monitoring visits. Data is King and quality is a close second. The Sponsor should focus on both throughout the study and make certain that any challenges brought up are researched and corrected or can be explained. Lastly, Code of Federal Regulations (CFR) Title 21 part 312.52 subpart D, Transfer of obligations to a contract research organization should be reviewed regularly but perhaps, it’s time for the FDA to update it.
Managing the CRO
Setting up weekly team meetings and perhaps quarterly face-to-face team meetings is standard. I suggest setting up weekly or bi-weekly 1:1 meetings with the lead/main clinical contact, depending on the location of the CRO these meetings can be in-person or via teleconference. The 1:1 meetings may be time-consuming but in my opinion, they do go a long way in developing an effective and supportive relationship. Discussing CRA performance concerns, data concerns, subject enrollment concerns and updating training is important and should be addressed on an ongoing bases. Also, in my opinion, for a late stage global clinical trial it may be prudent to set up pre end of investigator site enrollment audits early to address any data and/or quality issues, this is a discussion to have internally and with your CRO; the sponsor may not embrace this financial outlay but in the grand scheme of things this activity is indeed cost-effective.