In order for a physician to successfully land a study in an area that your site has no experience in, you will have to approach feasibility from a different perspective. Some of the other items you will want to highlight on feasibility and in your conversations with sponsors/CROs include:
- The physician’s clinical experience – Has he/she treated this indication in the clinic for several years? How many patients does he/she regularly see with this indication?
- Staff experience – Do other staff members have experience with studies in this indication? If yes, make sure to emphasize that the physician will be working very closely with these staff members.
- Community relationships – Will the physician be working with any experienced doctors in the community?
- Site experience – Has your site consistently performed well on other studies? Sponsors/CROs may be more willing to work with sites with a proven track record, even if the physician is new.
Also consider listing the new physician as a sub-investigator on all studies you are currently running. This will show sponsors/CROs that the new physician is involved in research, and will help you sell your case. Even though this may sound like a lot of work, remember that every PI has to conduct his or her first study sometime, so it is possible!
Q: Do you have any tips on handling the constant turnover at the CRO level? It seems like once you’ve established a good working relationship with someone, they move on.
Q: Do you have any recommendations for re-establishing relationships with companies that you haven’t worked with in a while?
A: It depends on how long it has been, but depending on the company you may need to start as if you are reaching out for the first time. Try to find new contacts, develop new relationships, and make yourself known to the new people at the company. When you do get in touch with the new contacts, make sure to mention that you previously worked with the company. Even if the people you worked with are no longer there, discussing certain studies the company worked on and you did well on can go a long way.
Depending on the size of the company, mentioning your previous contacts may be a good idea, as well. If the company is smaller, they may know the person you were previously in touch with. Ultimately, you will need to develop relationships with the new people as you would with any new company.
Q: What system or method do you use to keep track of contacts or time frames for calling back or checking back in?
Q: Does registering in a CRO database help?
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