Looking for a new site where you can perform your next clinical trial? As a Sponsor or CRO, you probably have access to a very robust database of investigators and sites, but sometimes you may have the need to find additional sites to fulfill the trial’s recruitment requirements. Choosing a new site can be a demanding process because you don’t know the site or you haven’t heard from them before. You may have some reserves at first and it is totally valid. Here are some tips to consider when approaching a new research site:
- Consider the site’s experience. Ask the site questions like the following:
- Who are the principal investigators?
- What medical background do they have? Do they have experience in clinical research?
- Who is the staff that works at the site? Does the staff have constant GCP training?
It is important to know that the staff knows how to perform a protocol and respects the good clinical practices. This will save you time training and responding to basic questions they should already know.
- Consider the site’s timelines. We understand that one in every ten molecules comes out to the market after all the research and development process is done. Performing clinical trials to test the safety and effectiveness of molecules is the most time-consuming part of all research and development process and, as you know, time is money. It is important to know right from the start answers to the following questions:
- How long does it take for the site to submit documents to the IRB and the MOH?
- How long does it take for the site to review and sign a contract?
- What are the site’s standards for entering CRFs and answering queries?
Answers to questions like these are important to know a site’s performance.
- Consider the site’s standard operating procedures (SOPs) and organization. It is very important to know that everyone in the company is doing what they are hired to do and that they are following standard operating procedures. This will give you confidence that the job is being done. This is also important when a new physician is incorporating himself or herself into the world of clinical trials. Sometimes Sponsors and CROs don’t give them opportunities to be principal investigators because of their lack of experience in clinical trials regardless of their medical practice experience. If they are motivated physicians that have the availability to participate in a clinical trial, you should take advantage of this. If the site is well organized and has its SOPs in place, be pretty sure the staff will be training the principal investigator so the job can be well done.
These points are the most important ones when considering a new site if you want to include them in a clinical trial. Contact us for more information and if you desire to know more about our timelines, SOPs and experience, we’ll be happy to share them.