This is always a challenge as there is a large amount of turnover at the sponsor and CRO levels. The best thing you can do is to follow your good contact to their new company. Utilize LinkedIn to find out where the contact has gone and reach out to the person via LinkedIn. This may help you get in with a company with which you may not have previously had a relationship. LinkedIn can also be a good resource to find out who has replaced your old contact. Once you know who that person is, you can introduce yourself and start out by discussing the relationship you have had with that company. If you have previously done studies for that sponsor or CRO, chances are you will be in their system and you can start building a new relationship.
What are the best metrics to present to sponsors to show the value of a site?
There are several great metrics that sites can present to demonstrate value to sponsors. Previous study metrics (# screened, # randomized, # goal, duration of enrollment) are always good, especially if you have them in a similar indication to the studies you are vying for. Showing that you are able to meet or exceed enrollment goals will always be great. Another area to highlight is patient population. Noting how many applicable patients you have in your database is key. Demonstrating that your database is searchable or is maintained through a CTMS system will also appeal to sponsors. Recruitment metrics are also helpful. While conducting budget negotiations, any previous metrics on recruitment, including which tactics have been most successful, can provide needed justification to convince sponsors to allocate a larger advertising budget.
Besides available equipment, what else should be included on a site’s website?
A site’s website should market to both patients and potential sponsor/CRO clients. For patients, you will want your site’s website to be encouraging; you want potential patients to be excited about clinical research after visiting your site. Include some basic information about clinical research so potential patients can understand the process. The most important item to have on your website for patients is a “current studies” section listing out the indications for which you are currently recruiting. Next to this section should be a contact form so patients can demonstrate their interest and the appropriate site staff can follow-up with a pre-screen. For sponsors, equipment and facility details are important. It also may be a good idea to state some companies you have previously worked with and a comprehensive list of indications your team has worked on while your site has been in operation. This will show your breadth of experience and make your site more attractive to potential sponsors.
What is the proper way to make a feasibility competitive without the risk of ruining your relationship with the sponsor?
This is always a somewhat controversial topic, however the idea is not to lie about your capabilities. Many sites fail to think about all of the resources available to them when filling out feasibilities and many times these sites end up selling themselves short. There are a few key areas to keep in mind when filling out feasibilities and two of them are detailed below:
- Patient population – When completing this section, many sites will stick to the exact number of patients the site has in the database. To be most competitive, you should think about ALL of the resources available to you. If you work with a sub-investigator, add an estimate of that doctor’s patient population. If you have relationships with community groups, add those patients too. When making an estimate of how quickly your site can enroll, think about all of these resources. You never want to make any promises that you cannot keep, but you should feel confident that by utilizing all of your relationships, you will be able to meet your stated goals. If not, it may be best to evaluate if the study is a good fit.
- PI availability – Sponsors always want to see that the PI is involved in the research. At the very least, the PI should be available for any patient visits. If you state that the PI is only involved with research less than 50-60% of the time, sponsors will usually screen your site out. If you show that the PI is available at virtually all times, your site will look much better to sponsors and CROs. If the PI really is only spending a minimal amount of time on research but is assigned to several studies, you may want to evaluate whether that PI is a good fit for your research site.