Strategies for Effective Clinical Site Management

The successful management of a clinical trial is a fine balance between multiple significant elements; rather it is the feasibility aspect, patient recruitment, optimized protocol, etc. The relationship with the clinical research site is often a point that goes unnoticed. Clinical research sites are integral to the success of clinical trials and the pathway to this success begins with maintaining positive professional rapports between sites and CROs. Fostering this kinship will be paramount to the overall flow of your trial as well as for future site collaborations, expediency and efficiency of the study start-up, facilitated budget and contract negotiations and, overall streamed line activation process.  

The following article will detail strategies for effective clinical site relationship management in your network.  

1. Trust  

Trust can be experienced between a CRO and sites through consistency, good judgment, expertise, and honesty. Removing any of these factors has the potential to disturb the relationship’s fragile balance. Trust must be a collaborative constancy for both parties, they must commit to the necessary efforts to deliver on their engagements and uphold their transparency on set expectations.  

2. Broad Scope Vision 

Developing strong connections with research sites includes having a good understanding of the site’s experience for the duration of the trial. The CRO has to be conscious of the resources the sites are working with and the challenges they are facing on a daily basis. The proper understanding of the site’s experience will enable the CRO to provide the necessary support to achieve their common goals. The following list of questions can be used as a guide to get the conversation started with your site to get a broad scope vision of their daily operations:  

1. How extensive is their workload? 
2. Are they experiencing resourcing issues?
3. What are their biggest hurdles to successful recruitment?
4. How can you support their operations?
5. Who is the site management contact person?
6. Is there an established communication schedule? 
7. What are realistic timelines for start-up or recruitment?
8. Is the site experienced in running local ad campaigns? Are they experienced in managing digital central ad campaigns? Is there support or guidance the CRO can provide for added support? 
9. What is the prescreening plan, and can it be enhanced? 
10. Is it realistically possible to start recruitment on your study right away or do they plan to start slightly later, knowing they will still meet their recruitment expectations?  

3. Communication 

Fostering an efficient relationship with a site begins with a genuine human connection between parties. As simple as it sounds, acknowledging the human behind the position goes a long way. This concept has been observed particularly when delivering bad news; empathy, respect, kindness can have a significant impact on the recovery of a given situation. Whether it is over the phone or by email, it is important that these aspects are conveyed in your communications.   

The importance of the relationship between a CRO and the research site is exemplified by the elements of trust, broad scope vision of the operations and finally, communication. It truly comes down to having both parties involved in the betterment of the connection to ultimately reach their established common goals. 

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About the Author 

Pamela Cassidy, M.Sc. Neuropharmacology is Innovaderm’s Sr. manager in site selection and contracting. She counts an extensive 10+ years of experience in clinical and pre-clinical settings. Her experience includes dermatology research site, several years’ experience in dermatology clinical research, including start up for multicentered global trials. Pamela has a proven track record on efficient site selection and contracting process, she has been fostering and maintaining established relationships with Innovaderm’s top sites.  

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