Clinical Researcher—April 2025 (Volume 39, Issue 2)

DATA-TECH CONNECT

Sid Mohamoodally

 

 

 

For sponsors and contract research organizations (CROs), trial complexity is increasing due to novel protocol requirements and greater demands on data volume and variety, among other factors. Meanwhile, the research and development pipeline has doubled from 10,479 products in 2013 to 21,292 in 2023. Sponsors are increasingly leaning on CRO expertise for newer therapeutic areas, technology infrastructure, evolving regulatory expertise, change management, and more.

As a result, the functional service provider (FSP) business model is growing. According to MarketsandMarkets, the global CRO market is estimated to be $82 billion in 2024 and poised to reach $129.8 billion by 2029, growing at a CAGR of 9.6% from 2024 to 2029.

At a recent Veeva Summit, two leading biopharmaceutical companies (Novo Nordisk and GlaxoSmithKline [GSK]) and the CROs they work with (Fortrea and a diversified CRO) reflected on how healthy sponsor-CRO partnerships can conquer ambitious goals and accelerate clinical data transformation.

Consider CRO Expertise Early to Meet Ambitious Goals

Implementing modern data management technology requires change and can potentially reduce study setup times by an estimated 50%. To gain the most benefit from the change, CRO partners can support the early planning and goal-setting stage. Ibrahim Kamstrup-Akkaoui, Vice President of Data Systems Innovation at Novo Nordisk, states: “It was a big change because data management is core to everything in our clinical development journey. With the right partners and their expertise, we aim to remove bottlenecks and design the process to reduce study setup [time]. Currently, it is eight weeks, and our target is four weeks. The trial simulation [with the new technology] shows that it is possible to do it even in two weeks.”

To achieve these initial milestones, Novo Nordisk prioritized partners with experience implementing a modern electronic data capture (EDC) and an approach aligned with their vision. Kamstrup-Akkaoui explained, “It’s valuable that there are partners out there who are well-trained and experienced in system setup and process design for managing similar trials the same way we want to.”

GSK’s earlier implementation of EDC software provided partners with valuable experience and a benchmark for what could be achieved. Alex Franklin, Director of Clinical Data Management at GSK, said, “For GSK, one of the biggest drivers for changing and adopting new technology was to accelerate delivery. We’ve decreased the time from final protocol approval to go-live by 50%. We’re now at a median of nine weeks.”

Franklin continued, “Next, we aim to reduce the time from last patient last visit [LPLV] to database lock to [just a few] days. We’re already down to a median of five weeks for non-priority studies and four weeks for priority studies. Our objective is to complete LPLV to submission in eight weeks. That doesn’t give much time from LPLV to database lock. We’re talking days.”

Complexity increases as trials explore new therapeutic areas and multiple indications, while studies are executed in shorter timelines and with greater flexibility. To meet these challenges, Novo Nordisk and GSK implemented EDC technology, which enabled rapid change requests and in-progress trial adjustments.

“When COVID hit, we needed to add forms to every single one of our studies to collect additional data, and we experienced the amount of manpower and effort that went into those amendments,” added Franklin. “The change management process within our modern EDC removes downtime and is much more streamlined. That was a key driver for the adoption.”

Prioritize Change Management to Improve Outcomes

Change management is critical to successful technology adoption, as it also drives a change in the process and the mindset. A clinical data executive from a diversified CRO explains: “What we’re talking about in this adoption for both organizations has been a radical change to the approach they had before—[and] not just [in terms of] the data management team members that would be impacted. We’re looking at the comprehensive team, including the sites, and understanding how the new technology will change how all stakeholders engage.”

The executive emphasized the flexible nature of change management, adding, “We learned early on that the change management plan must also adapt. It’s critical to have successes and recognize necessary adjustments to your plan when needed.”

GSK discussed how the newly created study liaison team enables ongoing change management by driving knowledge and collaboration. “This was a concept that we implemented right in the early days,” said Franklin. “The study liaison team members were the key points of contact that went from study to study. Their knowledge and their experience in the setup process were key to supporting those early studies. Because success is really your best champion to drive change.”

Franklin added, “Now, these team members are our key subject matter experts. They continue to drive value by working collaboratively with our CRO partners and Veeva in a one-team approach, rather than being on every study team as they were in the first 20 studies.”

While change management at project initiation is crucial, the process doesn’t end with implementation. “With three releases a year, we’re constantly assessing how the change will impact our user manuals or training documentation,” Franklin explained. “We consider what awareness we need to give to teams and what regression testing we need to do internally to ensure we can roll out changes in a streamlined manner to our global teams.”

Build Trust and Ensure Alignment to Drive Progress

Successfully deploying new solutions in clinical trials requires more than just expertise—it demands a foundation of trust among all stakeholders. This trust is built through ongoing dialogue, clear communication, and a deep understanding of needs and challenges.

Fortrea, a leading CRO, has developed a comprehensive approach emphasizing building trust. Its strategy relies on early engagement, personalized change management, and a holistic view of the entire clinical trial ecosystem. Eboni Russell, Vice President, Global Head of Clinical Data Management at Fortrea, said, “We were very intentional about meeting early and often, ensuring alignment and working towards the same goals to truly be an extension of the sponsor team. We discussed [key performance indicators], which are a great starting point, but it’s about establishing a baseline and showing progress.”

This early alignment keeps stakeholders on the same page throughout the project, but it’s insufficient. Trust is built with all the teams and individuals impacted by change. “People want to know how the change will impact them personally,” Russell added. “We schedule demos with study teams so they understand the changes and how they might impact their role. This way, they become part of the change rather than having it pushed on them, making it more successful. We [also] set up a series of working sessions for each function to discuss our goals and how to achieve change without disrupting deliverables, considering the tsunami of data that we’re all dealing with on a regular basis. For example, we connect directly to [application programming interfaces] to reduce the manual burden on sites, and they appreciate it.”

Encourage Collaboration to Advance Industry-Wide Innovation

CROs drive a virtuous cycle of innovation in the industry, acting as catalysts for progress across projects and companies. By building expertise and applying what they have learned, CROs and biopharmaceuticals work together to push the boundaries of previous advancements.

Fortrea’s Russell explained, “Nowadays, it’s not just a sponsor and a CRO, but it might be a sponsor, the software vendor, and multiple CROs in the space. So it’s about finding ways to level set expectations. As CROs, we see a variety of changes needed per customer, some of which result in evolving the roadmap for the technology itself. Our partnerships with software vendors are valuable in driving efficiencies to reduce timelines and get medicines to patients faster.”

The clinical data executive at a diversified CRO emphasized the benefits of the software provider-hosted CRO Data Council. “These meetings with other CROs give us a unified voice to drive things forward,” they said. “With this level of collaboration, the change in clinical data management that we’re pushing for is something we embrace in the industry. In fact, [the Society for Clinical Data Management] supports the change in the way we think of data beyond data management.”

This cycle of knowledge sharing and iterative innovation creates a powerful ecosystem of stepping stones, continuously pushing innovation.

Progressing Toward Faster, More Efficient Data Management

“As we look at that nine-week timeline and the 50% reduction for go-live, we know we could have reduced further,” said the CRO clinical data executive. “Initially, we wanted to achieve a lower target—two weeks for every study. Through dialogue, we realized the burden it puts on everybody else and quickly rationalized that nine weeks is already off the critical path. For now, that is a good start.”

He further emphasized that achieving a 50% reduction in trial setup requires more than technology, saying, “Modern technology disrupts the current state and makes people think about putting in something new. It’s hard to drive change only with technology without changing the process. Technology allowed us to look at the process, look at the people that were involved, and do a proper redesign to really capture the efficiencies.”

Sponsors and CROs are working together to advance how medicines are developed. Through agile partnerships, these companies are achieving greater flexibility and driving innovation in clinical trials to accelerate the delivery of new drugs to patients.

Sid Mohamoodally is Senior Director, Study Adoption, for Veeva.