There are several types of site operational models for clinical research including single site, academic institutions, site network and integrated research organisations. All these models have their own unique approaches and levels of efficacy based on the nature and purpose of trials. 



The Society for Clinical Research Sites (SCRS) organized a panel facilitated by Jennifer Byrne, Founder and CEO of Javara, an Integrated Research Organization, to discuss these site models and I had the opportunity to join other industry experts with varied background and specialties including; Justin Bandura, JD, Director, Strategic Alliance from Boehringer Ingelheim, Cynthia Dukes, PA, MT, Chief Business Officer at Benchmark Research and Dr. Richard Pollak, an Advisor/Consultant with previous experience as a PI and the Founder/President of Endeavor Clinical Trials.
 

The panel explored the advantages and disadvantages of the different site models, the various ways of organizing a site network and did a deep dive into the varied operational models that form the backbone of clinical studies.  It also discussed how sites could develop and nurture relationships to drive growth. 
 

Key questions discussed during this panel included:

‒      How can singular sites compete with larger networks of sites?

‒      How can sites in any model organize a productive business?
 


Singular sites vs site-network model: key takeaways 

‒      It was suggested that all sites regardless of model should ensure smooth execution of contracts and communicate line items clearly.

‒      Each site model brings unique capabilities and qualities to a study.  

‒      Sponsors and CROs should consider selecting various site types for their studies to increase trial efficiency and for faster site start-up.

‒      A singular site may not be able to start up as quickly as a site within a network or larger institution, but this may be offset by the Principal Investigator having more experience with the subjects needed for the study and be able to provide intuitive feedback on the protocol design.  

‒      Singular sites may also have built up trust in their communities from a long history of practicing in the area and be able to add to an engaged and diverse participant pool.  

‒      For singular sites, getting responses for studies could pose a challenge but it is important to be persistent; continued follow-up will eventually lead the site to being connected to the right person.  

‒      Once the site can establish a connection with the right person, it is much easier to begin a positive relationship and trust in sharing the pipeline of upcoming projects.  

It was proposed that using LinkedIn for connecting with the right personnel can be beneficial for single sites, that may lack relationships with sponsors and CROs. Searching the company page and looking for contacts with Site Activation, Site Alliances, Site Partner, or Site Lead in their titles will help with connecting to the right contact. Also leveraging existing contacts can lead to the selection of the right person for an ongoing relationship. 

 

Important factors for successful partnerships 

The attributes below are vital for building and maintaining successful relationships with sponsors and CROs, regardless of the site model type. 

‒      Budget awareness: Sites should have a good understanding of their expenses and budgetary needs when working with sponsors and CROs on clinical trial agreements.



‒      Time sensitive communication: Sites need to respond in a timely manner to any follow-ups or queries that occur during a study and sponsors and CROs need to hold themselves to the same standard of responsiveness.



‒      Transparency: Sites need to provide detailed information regarding how they ensure oversight and quality on each trial or project. 

 

Conclusion

The panel agreed that transparency, communication, engagement, and ability to provide metrics for enrollment, diversity, and other study KPIs can help a site, regardless of the model, in developing strong, beneficial relationships. It was revealed in a poll during the discussion that most of the attendees were from singular sites, and the topics and findings were extremely relevant to this specific audience, providing them with roadmaps and tips for successfully growing their operations.

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April has over 16 years’ experience working in clinical research across all phases and therapeutic areas within the CRO space. April was involved in the development of a Site Partnerships group at ICON, managing the CRO relationship with key site network contributors, and creating processes and new relationships to ensure KPIs were met across the company. She additionally served as Study Start-Up SME for a COVID-19 Bidding and Operations Team. April now works to leverage site relationships at the RFP stage to ensure ICON can provide accurate projected enrollment rates, site participation data, and protocol feedback to sponsors.