From Isolation to Integration: Improving Site-Sponsor Collaboration in Clinical Trial Startup

Christine Senn, Vice President, Site/Sponsor Innovation, Advarra

Clinical research is more complicated and expensive than ever. That means the journey from a medical hypothesis to a widely available treatment requires cooperation from numerous financial, regulatory, and research organizations. The closest working relationships within that ecosystem are between pharmaceutical, biotech, and medical device sponsors, contract research organizations (CROs), and clinical research sites.

These relationships over the years have struggled. To make transformative improvements in clinical trials, the entire industry needs to reimagine clinical research and collaborate in new ways to enter a new era of conducting clinical trials. Indeed, while clinical research in the last half-century has undergone countless advancements in the pursuit of safer, faster, and more effective drug, vaccine, and device development, many processes that require collaboration across sites, sponsors, and CROs feel painfully slow, redundant, and disconnected.

Despite sponsors and CROs having the best intentions, sites generally still experience the processes handed to them as “how things have always been done.” For all the intentionality of making improvements, there are still gaps. Sites still trudge through the same old processes, but now with added redundancy and burden as more and more technologies are imposed upon them from sponsors. In fact, according to a 2023 Study Activation Survey, 56% of sites cite technology as the biggest burden among all study startup activities.

“One issue that plagues sites is the lack of a universal process across all sponsors,” explained Rosalie Filling, vice president, senior global head R&D operations at Endo. “Sponsor A wants things done their way, Sponsor B wants to do it this way, Sponsor C wants to use this system…sites are left learning, managing, and juggling all of these different paths, which often impacts their ability to focus on the patients and trial execution.”

Together, the clinical research ‘village’ can solve the problems plaguing us. Here, sites, sponsors, and CROs discuss three top clinical trial pain points and potential remedies.

Pain point 1: Feasibility

Almost half (49%) of sites report the burden of feasibility surveys has increased over the past five years. The feasibility process, where redundant questions and cumbersome processes create inefficiency, is universally dreaded by sites and sponsors alike.

“We take on hundreds of studies a year,” said Denise Snyder, associate dean for clinical research for Duke University School of Medicine. “We want to avoid repeating the intake process every time we consider a new study.”

“You should have the table stakes figured out,” echoed Nick Spittal, chief operations officer from Velocity Clinical Research, the largest global organization of fully owned clinical research sites. “Feasibility can be boiled down to basically two questions: 'Do I have access to the appropriate study subjects at my site?' And 'How many of them can I enroll in the planned time frame?' Everything else, like ‘I don’t have ACME centrifuge model XN84,’ can be figured out later.”

What can we do better?

Rather than the current practice of reaching out directly to the principal investigator and asking redundant or non-study-specific questions in site feasibility questionnaires, sponsors and CROs should reach out to a central office for their sites. It would also be helpful to pull previous site and/or PI data already on file rather than asking the site to start from scratch; instead, they could verify the information.

For their part, sites can help by creating a resource or one-pager that directs sponsors to their central research office and respond to feasibility questionnaires with that document. Sites can also create email distribution lists for departments such as regulatory, contracts and budgets, and business development (for trial leads and feasibility questionnaires) to both make the process easier on sponsors and CROs and ensure a site doesn’t lose work or progress when an employee goes on vacation or departs the organization.

Technology can streamline the entire feasibility process. In a single system, sponsors can send feasibility surveys to sites to complete, and if sites have completed it before, they simply need to confirm or update their information. When sites and sponsors collaborate in the same system, they streamline communication and get instant visibility into the process.

Pain point 2: Site qualification visits/site initiation visits

Site qualification visits (SQVs) have tremendous opportunities to be streamlined. Qualification should be a relatively static, non-protocol-specific assessment that occurs only periodically. Sites could have platforms that sponsors could access with administrative information about facilities and their capabilities. In-person reviews could happen less frequently, perhaps annually. With both those components in place, SQVs could be waived—as is already done when a site and CRO/sponsor have a preferred partnership. Lastly, sponsors could use CT.gov to collect resumes, licenses, and other information about sites.

“Sites often view SQVs as sunk costs because they are pulling staff away from patients,” explained Nick Palumbo, director of feasibility and enrollment forecasting at Takeda. “We are trying to aggregate various data sets and metrics to take this visit off the critical path. For instance, we look at historical relationships, performance metrics, and feasibility questionnaire responses plus other insights and then may pre-qualify the site before a visit. Some sites are also requesting the pre-study meeting to be virtual, where possible.”

Similarly, the site initiation visit (SIV)is also worth revisiting. This critical meeting occurs before a site begins enrolling patients to ensure that they are fully prepared to conduct the study according to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Fundamentally, SIVs are about teaching the clinical site how to successfully enroll patients and ensure that the process follows the protocol in a quality manner. But too often, they try to accomplish too much at once.

What can we do better?

Ideally, the focus of the SIV should be on practical, immediate tasks and questions that may arise during the first few visits, rather than preparing for far-off future events (e.g., closing the trial). SIVs should provide everyday advice, such as what to do if unexpected clinical results occur and who to contact for immediate assistance. Some parts of the SIV, such as verifying temperature logs for freezers, could also be streamlined by sending logs via email or a shared cloud-based platform rather than physical inspection. Sponsors could also consider providing long-term training modules to alleviate the need for lengthy SIVs.

Rather than using PowerPoint decks or antiquated systems, sponsors can increase collaboration by providing an engaging learning management system where site teams are properly trained on the trial. This ensures compliance and reduces protocol deviation, giving sponsors the confidence that their sites have what they need to conduct the trial.

Pain point 3: Contracts and budgets

Contracts and budgets continue to be a thorn in the side of sites, sponsors, and CROs alike. Contract and budget (C&B) negotiations significantly delay site activation, often taking eight weeks—even longer for some institutions. A major challenge arises from the lack of transparency in the C&B process, as sponsors often do not allow CROs to access previous agreements, even when there is an existing relationship between the sponsor and the site. Additionally, while sites are asked to justify their charges, they do not usually receive justification in return. This is especially true in the US in Medicare Coverage Analyses (MCAs). Without justification, C&B negotiations take longer and, where an MCA is needed, the site must start from scratch with their own analysis, which can add weeks to the process.

“We hate being stuck in the back-and-forth, inefficient rework cycles involving contracts, budgets, and amendments,” added Mark King, vice president of research and innovation at Novant Health, an integrated network of more than 850 healthcare sites, including 19 hospitals. “Sponsors/CROs must recognize that mid to large-sized trial sites are working with many sponsors simultaneously. We have dozens of studies in start-up at the same time. Those who can supply final documents early and respond to questions quickly are going to have their trials opened more efficiently. When there are outstanding documents, drafts, or amendments in play, studies may be de-prioritized by sites, significantly impacting timelines.”

Takeda’s Palumbo added, “We know this is a major pain point, so we try to establish master clinical trial agreements (CTAs) with preferred sites using agreed-upon standard language, but it is still difficult. To help expedite timelines and gain accountability, we have taken a lot of that negotiation work in-house. The larger academic centers have a lot of administrative red tape, especially in oncology, and it tends to slow site activation.”

What can we do better?

First, learning from successful sponsor-site and CRO-site preferred partner programs can provide valuable insights into optimizing contract and budget management in clinical trials. Sponsors and CROs can make better use of existing contract and budget terms to reduce negotiation times and associated burdens on sites. Pre-negotiated contracts and budgets should cover non-protocol-specific items such as CTAs, confidential disclosure agreements (CDAs), and consent language. Additionally, budgets for common procedures like ECGs, infusions, and consent should be pre-negotiated and updated annually. Exploring the use of artificial intelligence to extract language for a master contract template could further streamline the process.

There is also a pressing need for enhanced communication between sponsors, CROs, and sites throughout the C&B process. Ensuring that outstanding documents, drafts, and amendments are addressed promptly will reduce site activation delays. Stakeholders might consider adopting a dedicated platform for C&B document exchange and version control. And using integrated technology solutions that connect site-owned systems with sponsor-provided platforms can also minimize duplicate work and streamline document management.

“To improve collaboration, we need interoperability of IT systems within a site’s tech stack and with sponsor/CRO systems,” added King. Collectively, we spend an absurd amount of time manually creating pipes to connect systems. Our systems are replete with redundant manual data (re)entry—for instance, consider the study title alone. How many times will that be typed into multiple systems? 12, 20 times? Let’s create a solution where the simple NCT number from clinicaltrials.gov populates all these systems automatically.”

Lastly, sites commonly request budget support for participant compensation, CRO monitoring visits, and remote monitoring setup, but reimbursement inquiries for site technology setup are less common. Establishing a standard compensation framework for site technology use during study planning and budgeting would help streamline the process.

“Increasingly, the industry is trying to improve processes in the name of the patient, but our initiatives need to be industry wide, leveraging technology better to create industry standards,” said Palumbo. “Can we use modern technology to automate more workflows, leverage data better, and share more information? Yes, we can move the needle if we work together.”

The path to enhanced collaboration

The relationship between sites and sponsors/CROs is historically thorny—after all, a 2024 Advarra survey shows that 43% of sites say “complicated” best describes their experience working with CROs (43%) and sponsors (38%), while 38% of sponsors also described working with sites as “complicated.”

It may not be easy, but the path forward must start with improving processes, communication, and technology to reduce the time and effort required for study startup. We are better together than apart. Only by committing to be part of our theoretical village, can the industry productively collaborate and come together to accelerate study activation and improve the overall efficiency of clinical research.

Christine Senn, vice president, site/sponsor innovation, Advarra