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Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites

“Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites” was originally published in Clinical Leader. Click here to read the original article.

There are many elements that influence a site’s choice to accept a clinical study, particularly when multiple studies are participating and when equally promising treatments in similar patient populations are being studied. Sponsors can influence site choices by creating a positive sponsor-site relationship from the onset, which includes making design decisions that consider the patient perspective and making execution decisions that alleviate common operational challenges, reduce the burden on sites and their personnel, avoid protocol amendments, and help to dodge operational surprises.

As with every industry, there is a concern for the value of time in bringing a product to market. However, in clinical research, the value of time has added meaning, particularly for patients with serious diseases where a marketed product can mean a longer life or the potential for a better quality of life. So, taking the time at the beginning of a study to increase the likelihood of success, in the end, can be a worthwhile trade-off and can often save money in the long run.

Considering Patient Perspectives

To achieve the goal of building more efficient trials, sponsors should strive for meaningful relationships with sites to collaborate and learn about the patient journey with the goal of making trials as simple and easy as possible for the patient to understand, access, and participate in. Additionally, sponsors can engage with patient advocacy groups to review the schedule of events and informed consent form(s) (ICFs) to identify any aspects of the trial that may be significant barriers for patients. 

When patients are the driving force in all that sites accomplish, these patient-centric efforts will further nurture the sponsor-site relationship and can also provide patients with confidence when making the decision to join a study. 

Initiating Sponsor-Site Relationships

Initiating and nurturing sponsor-site relationships can be a daunting task, especially with the mounting pressure for increased development speed to bring investigational products from bench to bedside and the increased competition within the clinical space. 

Here are some ways to initiate site connections:

Real-World Examples To Reduce Site Burden & Nurture Meaningful Sponsor-Site Relationships

Operationalizing trials more effectively not only strengthens relationships with sites but also helps sponsors to spend less money and time throughout the course of the study. In addition to obtaining patient perspectives on a study, it is also valuable to receive site input on the draft protocol. By speaking with KOLs and study coordinators in advance of protocol finalization, sponsors can confirm the study is operationally feasible. Planning for this step in the timeline for protocol finalization and first patient in (FPI) can allow sponsors to avoid unnecessary protocol amendments. Protocol amendments cost sites and sponsors time, money, focus, and momentum – all of which cause additional site burden and may lead to a negative perception of the sponsor or decreased likelihood of success or timely completion of the study. 

Reducing the burden on sites and minimizing operational surprises are some productive ways to foster meaningful sponsor-site relationships. Specific examples are outlined below. Although some of these suggestions may seem minor, the amount of time that is saved and the acknowledgment that site staff time is valuable will be appreciated.

It’s best to think long-term when discussing nurturing site connections. While each trial will have its own complexities along with common challenges, site connections can be navigated with ease when sponsors are prepared to address issues and resolutions. Sites will be more likely to choose sponsors who view them as partners and take time to discuss challenges with them and implement mitigation strategies.

Value connections with investigators, including and beyond KOLs:

Ultimately, the early effort a company puts into site relationship building and maintenance can set the sponsor up for success and helps differentiate them to the site amongst competitors. As a sponsor, if you come to the initial site connection with a willingness to understand the site and patient journeys, and to make accommodations accordingly, you can set yourself apart and generate a positive first impression and strong foundation for the sponsor-site relationship.


  1. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Ther InnovRegulSci. 2016 Jul;50(4):436-441. doi: 10.1177/2168479016632271.

About The Authors:

Mary Malloy, Ph.D., is a consultant at Halloran Consulting Group. She is a FINRA-registered investment banker with more than eight years of experience in life science-based corporate transactions and cross-functional project management. Her doctoral research encompassed investigating protein matrix interactions in the neurodegeneration space. She also has experience in strategic advisory for emerging biotech companies, agnostic of therapeutic area or modality. Her consulting experience has been focused on scientific due diligence, market landscape analysis, and primary research with key stakeholders, and she frequently operations as the nexus of several functional heads of a life science start-up as a program manager.

Nikki Cammarata is consultant at Halloran Consulting Group. She has more than seven years of experience in conducting early- and late-phase clinical trials. She uses her experience within clinical operations and clinical systems to act as a clinical trial manager for global studies and to lead CTMS and eTMF implementations.