Sponsors/CROs award their trials to the most qualified sites. Therefore, in order to survive the Darwinism of the site selection process, sites must impress sponsors/CROs and prove that they have the ability to run their trials effectively and efficiently. Here at ClinEdge, we represent sites from all over the world with various infrastructure capacities and research experience. We have noticed the following qualities in our most sought after sites:
- Strong infrastructure. Having a strong infrastructure is not limited to the number of employees at a specific site. It also includes strong communication pathways, access to resources, and community involvement.
- Having strong external communication pathways to your sponsor/CRO, including being thorough and accurate on feasibilities, is equally as important as having strong internal communication within your site. Sponsors/CROs want to know that you are capable of handling their trial and that if something goes wrong, your clinical research team can work together to address and resolve the problem quickly and efficiently.
- Having access to appropriate resources is incredibly important to a sponsor/CRO. "Resources" includes the personnel needed to conduct a trial effectively - specialists for the specific indication, adequate staff running the trial (coordinators, regulatory specialists, and raters, if necessary), study-specific machinery (X-ray, EKG, MRI, etc.), and access to a lab and/or pharmacy. While it may be expensive to acquire specific machinery, or to hire additional personnel for a specific study, it can pay off in the long run and will please the sponsors/CROs that are seeking out sites with very specific resources.
- On the surface, community involvement does not sound like it would be something that a sponsor or CRO would consider when looking at a site, but reputation is everything in this field! If a research site is involved in their community and attends local advocacy walks and events, they will brand themselves as a site that genuinely cares; potential patients will naturally gravitate towards them. Sponsors/CROs recognize this as a benefit.
- Easy access to necessary data. With all of the continuously moving pieces that are involved in a clinical trial, knowing that a site can remain organized despite the pressures and ever-changing timelines is critical to a sponsor/CRO.
- Having your in-house timelines available for the sponsor/CRO to review is an easy way to sell your site. How long does it take your site to produce a CDA? Complete FQs and IRB submissions? Having this information and more on hand can give your site the competitive edge it needs to be a more impressive contender compared to sites that may have the same strengths but lack information or quick document turnaround.
- Your research site's metrics should always be organized and up to date. You will want to provide sponsors/CROs with data on previous trials your site has completed. Note what indications the studies were for, how many patients were anticipated to enroll vs. how many actually enrolled, and the duration of the trial. You should also note the sponsors/CROs you worked with on previous trials, enrollment numbers for specific indications, and your patient database specifics (demographics, indication, etc.).
- Strong recruitment strategies. Valuable patient databases include not only a high volume of patients, but also a variety of patients spanning across numerous therapeutic areas. This shows sponsors that when you are sent a preliminary feasibility questionnaire or basic study information, your team can start identifying patients based just on your database alone. This is always a helpful head-start when preparing for a trial.
- Community and physician referrals also look really good to sponsors/CROs. As stated earlier, reputation is everything in this field. Knowing that your community and fellow physicians trust you means that the sponsor/CRO can trust you too.
- Of course, enrollment may not be completely fulfilled through your patient database and referring physicians. You will often need to do a little marketing and advertising, in addtion. Sponsors/CROs understand this, and most of the time, they expect it. With that being said, they want to make sure that you are not allocating an enormous amount of funds to marketing and advertising. Having a solid plan of action for where and how much money is being allocated to marketing and advertising as well as the expected return, will please and ease the minds of sponsors/CROs.
- Be yourself! As cliché as this piece of advice may sound, it is true that the unique characteristic your site can bring to the table is going to be what makes you stand out next to your competition! Highlight your strengths as a site and show why a sponsor/CRO would want to work with you. Does the blend of personalities in your office allow for a highly efficient workflow? Are you quick to identify, address, and resolve problems? Are you punctual? Communicative? Amicable? Even the area in which a CRA would be working during site visits can be important. Will they be sitting in a small corner or sharing a desk with another employee? Or will they have their own desk with plenty of room to work? Even the smallest factors have the potential to give you a leg up when it comes to impressing the sponsor/CRO.
For more on improving the health of your overall site, watch our webinar!
Post by Brandi Maher -
Brandi comes to ClinEdge with a strong background in Oncology Clinical Research and brings a Research Site perspective to her role here as a Clinical Operations Coordinator. Having managed key research functions in her previous role, Brandi’s unique experience allows her to develop and maintain long lasting relationships with both research sites and Pharmaceutical sponsors by being able to offer a genuine understanding of the needs of both parties involved in the clinical trial.