A couple of years ago, my site decided to embark on sourcing our own studies as part of a new site business development project.
Unlike some sites, who hire in-house clinical trial business developers, everyone at my site was expected to contribute-- from site manager to study coordinator. My site has always been focused on site enrollment and clinical operations; unfortunately, we knew little about business development tactics.
We started by talking to CRAs and other investigators we knew, but they did not have much advice for us. Through much trial and error we managed to put together a process for sourcing studies on our own. We learned invaluable lessons and I feel it is important to share these business development tactics with fellow research sites.
Searching for research studies - where to start
Most sponsors/CROs have their own Investigator Database or Registry. You should be able to find these databases if you spend some time on a sponsor or CRO's website. Fill in your PI's information and sign up for updates on future studies that spark your interest and match your PI's specialization.
There are also investigator registries like Transcelerate's SIP and DrugDev's Investigator that multiple sponsors/CROs use to find sites. You can register your PI in these databases and when a new study in the therapeutic area that you've checked off becomes available, you or your PI will be notified and asked about your interest. You may even be able to find some companies that have their own preferential directories that make it easy for sponsors to find high performing sites (Editor's note: CRIO's directory is coming soon!).
You can also go to clinicaltrials.gov and filter studies per therapeutic area and country/region. Focus on studies that are labeled "recruiting" and "not yet recruiting" to find available studies for your site. Reach out to all study contacts listed on the study page.
My team and I relentlessly spammed people using clinicaltrials.gov.
(Nope. Not ashamed at all! When you need business you need to spam!)
We have even Googled pharma companies that have pipelines in our area of interest and spent hours cold-calling contacts.
A lot of people will brush you off!! It's a disheartening process but keep at it.
Networking is key for business development
Going to conferences like DIA, SCRS, and ACRP is a good way to meet sponsors and CROs who may have studies in their pipeline. Even if you realize the person you're talking to doesn't directly handle site selection, a good conversation with anyone at such conferences is completely worth your time.
I once spoke to a gentleman from a pharma company at the SCRS conference about enrollment issues in pain studies and how my site overcomes them. After the conference, the gentleman emailed me about an upcoming pain study and put me in touch with site selection! He also made site selection aware of our success in this therapeutic area.
Prepare your sales pitch, put it in a nutshell
Draft an "introductory email" template.
This email is basically a sales pitch about your site, so list out your strengths.
E.g. "Dr. Elizabeth Blackwell is a board certified Dermatologist with over 12 years of experience on industry sponsored clinical trials." OR "We have a full-time enrollment specialist who pre-screens from our extensive database of 8000 patients."
Keep this email short and concise. No one is going to read a long email from a stranger. Use such templates for your email "campaign." Have a similar phone script ready for people you call.
The emailing technique has worked for my site-- some sponsors emailed back asking for the PI's CV or saying they have studies coming up. Phone calls were less effective for us, but they may lead you to a PI registry portal or the site selection mailbox.
At some point you will start getting notifications about potential studies from various sponsors--that is when you know you're doing something right. These notifications will usually contain a disclosure agreement and a survey called a feasibility questionnaire.
The feasibility questionnaire is your main sales pitch.
Highlight your site's strengths and be optimistic when projecting enrollment numbers.
(DO NOT LIE)
Don't be afraid to turn down a study when you can clearly see that you don't have the patient population or the capability to do it. Speaking from personal experience, taking on a study that is impossible to do will cause more harm than you think.
Follow-up is the 90% of the iceberg that is underwater
Keep track of every study you apply to and regularly follow up with your contacts for updates.
Due diligence is a very tough job.
Make sure your follow-ups are not so frequent that they're annoying. Make note of all updates. Even when you get rejected, always ask for a reason or feedback. This tracking will eventually allow you to see patterns and understand where your site needs improvement.
If a study has completed site selection without you, always ask for a "backup spot." There are times when a site drops out or the study is having trouble meeting its enrollment target. The sponsor will then look for 'add-on' sites, leaving a perfect opportunity for your site to get on board.
There will be challenges
When I was doing study sourcing, I found that following up on study leads was the toughest part because study contacts are not as responsive to individual sites-- sponsors would rather have a list of sites from a site network or a study broker they already know. Study brokers offer advantages to a site because your likelihood of getting shortlisted for a site qualification visit increases. However, some small sites may not be able to afford the price tag that comes with having a broker.
It's a long wait
This self-sourcing model will take time before you start seeing payoff. You will realize that building relationships is a very time-consuming process.
We're talking 2-3 years here!
But over the years, you will manage to win studies. You can then build on existing relationships to get more studies. If you're a well-performing site with solid site management, it will not be hard to impress people!
Dipti worked at a clinical research site in Massachusetts where she managed day-to-day clinical operations and regulatory documentation. She started her career in clinical research at a CRO working on Trial Master File and drug safety reports. She holds a Master's degree in Regulatory Affairs from Northeastern University.