Global drug developers and investigators sites both recognize the value of being a good partner with the other party, but tensions are frequent in relationships between sponsors and sites. In forums at industry conferences to discuss sponsor-site relationships, these tensions are brought into the daylight, and it’s easy to discern that complaints about the relationship overwhelmingly come from the investigator sites, whereas study sponsors seem mostly complacent. In the author’s experience, sponsors often express words of encouragement and support for improving relationships, but this usually falls short of critical self-evaluation.

To understand how study sponsors and investigator sites can work together better, it’s important to recognize the dynamic of the relationship. Simply put, sponsors are in the lead position and investigator sites are in the reliant position for almost all aspects of the relationship. And as the lead party in the relationship, it befalls sponsors to take responsibility for ensuring that the relationship is healthy and mutually beneficial.

Think about it: sponsors design the drug development program, define every aspect of individual study protocols, provide necessary funding to study sites, conduct extensive oversight of study sites, deploy almost all the technology platforms used in the study, often stipulate a central IRB, and own the data resulting from the trial. Sponsors also put forth the clinical trial agreement and site budget, and although negotiation is involved, sponsors ultimately decide which sites they prefer to work with.

In these ways and others, sponsors have the upper hand in the most meaningful elements of the sponsor-site relationship. The power dynamic is partially moderated after a site is selected and activated, because the sponsor then becomes reliant on the site to enroll adequate numbers of patients. Also, some principal investigators may be influential leaders in their field of medicine, adding some clout to their relationship with sponsors. But these considerations only marginally counterbalance the position sponsors hold as the lead partner.

With great power, as they say, comes great responsibility. Sponsors rightfully have the greater burden to create the basis for a positive relationship, and to foster that relationship over the lifetime of each study. Doing so is clearly a win-win for both sponsors and sites, so sponsors have every reason to do better. So why exactly don’t sponsors more effectively take the lead in ensuring better relationships with sites?

The answer is NOT that sponsors don’t appreciate what the issues are, or that they lack an understanding of the actions required to do better. Numerous surveys over the years have consistently enumerated the aspects of clinical trials that matter to sites, as well as the widespread perception that sponsors need to do things differently and better. For instance, the issue of “getting paid fairly and on-time” has been one of the top complaints of study sites in every survey for the last two decades. And for reference, the checklist at the end of this article is shown exactly as it was generated from Microsoft Copilot AI, and it provides a fair and accurate overview of areas where sponsors can do a better job of supporting sites. So as far as solutions go, sponsors need to do little more than look it up.

If the answers are so obvious, then why don’t sponsors do a better job partnering with investigator sites? The disconnect appears to stem from a series of organizational issues, or as management consultants like to say, “Culture trumps everything.”

Sponsor perspective.

Understandably, sponsors tend to design clinical trials to meet the priorities of sponsors, not investigator sites. In recent years, more emphasis has been placed on designing patient-centric protocols that incorporate patient-listening and other tactics intended to help design trials around the needs of study subjects. If only the same were true for investigator sites. Some sponsors do expose study protocols to advisory boards that include investigators, but often the review is at a scientific level that does not reach down into the practical logistics of each study. By the time the protocol is reviewed for comment at an investigator meeting, the details of the protocol are generally locked in. Clearly, there’s an opportunity for sponsors to gain more meaningful input from investigator sites while the operational protocol is still in development.

Keep Listening.

Sponsors need to benefit from input by investigators at the critical phase of study design, but it doesn’t end there. Sponsors also need to actively solicit feedback from sites during the initial phase of study roll-out, and sustain site-listening activities throughout the life of the study. For instance, sites are the first to sense if there are critical issues regarding patient screening and enrollment eligibility, and sponsors should not only pay close attention, but be open to amending eligibility criteria based on “early warning” feedback from sites – it might just save the study. Other little-used listening tactics include site polling, discussion groups and social media formats.

Competing priorities.

Invariably, study teams comprise busy people who have multiple competing responsibilities. The period leading up to the launch of a new clinical trial is a time of peak activity, causing study teams to focus on the highest priorities, that is, those core activities that are absolutely required to achieve a study launch. As well-intentioned as study team members may be, competing priorities cause them to miss opportunities to implement tactics that better support sites. This includes items as common sense as developing better, more engaging study training materials, or implementing an information access hub for sites. Another barrier is that many of these tactics require a budget, and even a small budget can be an impediment for anything perceived as a second-tier priority. Also, inattention to investigator sites can be happen simply because, within a study team, no one person has the assignment of providing better site support.

Leadership.

The involvement of leadership is necessary to address many of the issues and actions outlined in Chart 1, so support from senior leadership in clinical operations is essential to optimize the working relationship between sponsors and sites. Leadership has to reinforce this as a priority and generally foster a mindset of being “site-centric,” that is, fully committed to excellence in services supporting study sites. To make this actionable, a site-centric program needs to be translated into a series of best practice SOPs, defined projects, and approved budgets. Lastly, a group of empowered individuals within clinical operations need to be tasked with implementing a program to improve working relationships with investigator sites.

The challenges and solutions to improving the sponsor-site relationship are well known, but to effect real change, the leadership, priorities, and actions outlined above are needed.  Fortunately, a strong site-centric culture is a certain path to clinical trials that work better and bring success to both sides of the all-important sponsor-site partnership.

 

Appendix 1.  Microsoft Copilot AI response to: What factors are most important to investigator sites in working effectively with clinical trial sponsors?

1. Clear and Feasible Protocols

• Protocols that are scientifically sound and operationally realistic.
• Minimal burden on site staff and patients.
• Flexibility in visit windows and procedures when possible.

2. Transparent and Timely Communication

• Regular updates and responsiveness from sponsor or CRO teams.
• Clear guidance on expectations, timelines, and changes.
• Collaborative approach to problem-solving.

3. Efficient Study Startup

• Streamlined contracting and budgeting processes.
• Support with IRB submissions and regulatory documentation.
• Realistic timelines and proactive planning.

4. Fair Compensation and Reliable Payments

• Budgets that reflect actual effort, overhead, and pass-through costs.
• Timely payments with simple invoicing procedures.
• Financial transparency and flexibility.

5. Recruitment and Retention Support

• Tools and resources to help sites find and keep patients (e.g., advertising, concierge services).
• Realistic enrollment targets and inclusion/exclusion criteria.
• Sponsor-provided materials and platforms for outreach.

6. Respect for Site Expertise and Autonomy

• Involving investigators in protocol development or advisory boards.
• Trusting sites to manage their workflow and patient relationships.
• Avoiding micromanagement or excessive monitoring.

7. Strong Relationship and Reputation

• Sponsors with a history of ethical conduct and scientific rigor.
• Positive past experiences and long-term partnerships.
• Recognition of site contributions and performance.

8. Operational Support and Training

• Access to technology platforms (e.g., EDC, eConsent, CTMS) with proper training.
• Clear SOPs and guidance documents.
• Responsive helpdesk or CRA support.

 

About MedPoint Digital, Inc.

MedPoint Digital, Inc. partners with biopharma companies to deploy virtual pharmaceutical meetings and advanced portals that produce unique value. Our goals are to lower costs, improve quality and expedite timelines with digital platforms that transform key areas of clinical operations, commercial objectives, and study site tasks.