2024 in Focus: Predictions from Florence’s Top Leaders on Clinical Research Collaboration

As we enter 2024, understanding the evolving dynamics of collaboration among sites, sponsors, and CROs is crucial. This blog post features an interview with four leaders from Florence – Ryan Jones, CEO; Catherine Gregor, Chief Clinical Trial Officer; Kristin Surdam, Sr. Director, KOL & Strategy; and Mike Wenger, VP of Solutions.

They share their thoughts on how technology is shaping collaboration, their expectations for new technological investments, and the barriers they hope to overcome in the next year. Their perspectives provide a clear view of the anticipated trends and challenges in the industry, offering a practical outlook for the future of clinical research collaboration.

Ryan Jones:
Two trends will signify the maturation of site-CRO-sponsor collaboration. Firstly, more sponsors will start reimbursing sites for their own technology like eISF, eSource, and eConsent. Secondly, the eClinical space, which has seen a surge in vendor numbers, will start to consolidate, either through integration or mergers and acquisitions.

Catherine Gregor:
The collaboration on purpose-built enablement technologies between sponsors, sites, and CROs is expected to enhance operational capacity, reduce risks, and accelerate clinical trials. This includes eliminating duplicate work, facilitating remote oversight, and automating workflows. Particularly, the integration of systems and remote-first platforms will enable new research entities like pharmacies and community clinics to participate in studies, maintaining real-time monitoring from sponsors and CROs.

Kristin Surdam:
The year 2023 marked significant growth in collaboration across stakeholders in clinical research. We observed a shift from sponsors and CROs creating solutions for sites to actively seeking input to understand their needs. This change is a precursor to an exciting 2024, where I anticipate more tech partnerships, encouraged integrations, and a variety of tech solutions being offered to sites. This approach is expected to foster symbiotic relationships over individualistic competition.

Mike Wenger:
The focus in site technology will shift from streamlining primary clinical research workflows, such as EDC, CTMS, and eISF, to enhancing workflow coherence across these systems. The integration of solutions that address additional workflows, which currently rely on manual processes, is exciting. Additionally, creating “data bridges” between Sponsor/CRO systems and site systems to avoid data duplication and improve communication is a significant development to look forward to.

Ryan Jones:
Two areas ripe for digitization are feasibility and document exchange. Digitizing feasibility data in a platform controlled by sites can reduce redundant work and repurpose this data for marketing, helping sites better position themselves and assisting sponsors in making informed site selections. Orchestrating document exchange for study startups, budgets, and contracts in a single system will not only expedite the process but also reveal the real bottlenecks in study startups. This move towards fully trackable clinical operations work will facilitate faster market access, lower risk, and more efficient development of cures.

Catherine Gregor:
Continued growth in eConsent adoption is anticipated, driven by a shift towards site-initiated implementation. This aligns with FDA guidelines on enhancing trial diversity and promoting decentralized trials. A significant development I hope to see is a modernized approach to site feasibility. The current process, often laden with repetitive surveys and outdated data, is ripe for reinvention. Advanced tech solutions should leverage existing data for smarter feasibility assessments and allow for real-time data updates, aiding sponsors and sites in making more informed decisions.

Kristin Surdam:
The focus for sites is shifting from eConsent to eSource. This transition is well-aligned with sites’ traditional responsibilities and addresses the issue of managing multiple systems, a significant challenge for many sites. The integration of eSource platforms with electronic health records will further enhance their utility. For sponsors, the emphasis will be on Real-World Evidence (RWE) solutions, driven by the FDA’s growing requirements for post-marketing data. This approach will likely be more efficient and cost-effective than traditional phase IV trials. Furthermore, the integration of AI and ML in healthcare and clinical research will evolve, though it may require trial and error towards standard adoption. Enhanced technology integrations by sponsors/CROs will be crucial for maintaining cross-study visibility and effective trial oversight.

Mike Wenger:
As clinical trial sites face a growing range of technological options, the challenge is maximizing their potential and integrating them to streamline processes. The next year will likely see an increase in best practice sharing and consultancy support for sites to optimize their technology investments. Improved data exchange methods with sponsors and CROs will enhance site selection prospects. Sponsors, on their part, will focus on tools that ensure data quality and timeliness, providing early insights into site operations to scale up efficiently.

Ryan Jones:
A significant accelerant for clinical trial productivity is in the hands of European regulators. The improvement we’ve seen in the Americas stems from sites feeling both empowered and compliant. In contrast, European sites are hesitant to digitize, fearing regulatory repercussions. Clearer guidelines, like the emerging ICH E6 R3, could boost confidence in adopting technology. I urge groups like ACRO, DCTRA, and Transcelerate to push the EMA and MHRA towards more assertive support for remote and digital site technologies.

Catherine Gregor:
Interoperability is key. Different systems must communicate effectively, reducing the burden on site and study staff. We need a focus on creating an ecosystem of interoperable platforms between sites and sponsors, rather than isolated, closed systems. Vendors should prioritize building these connections to support diverse and specific needs, ensuring that there isn’t a one-size-fits-all approach, which often falls short.

Kristin Surdam:
The historical challenge has been the overabundance of technology imposed on sites by sponsors and CROs. With a shift towards soliciting site perspectives, I anticipate a growing demand for solutions focused on tech interoperability. It’s essential for technology service providers to move from a mindset of competition to one of collaboration. Those who ignore interoperability will likely fall behind. There’s a need for sponsors to invest in site-centric technologies, urging vendors to collaborate with their former competitors, which is vital for streamlining workflows and accelerating market access for new therapies.

Mike Wenger:
The perspective of sponsors needs a fundamental shift. They must recognize that research site staff are engaged in multiple studies simultaneously. Relying on study-specific custom portals adds to the already overwhelming number of systems they have to navigate. Instead, the focus should be on integrating solutions into the existing workflows and tools that sites already use, streamlining the process rather than complicating it further.

Ryan Jones:
The “Sponsor Digital Mandate” is set to become a significant theme. With the rise in eClinical vendors, sites face challenges in adopting and training for numerous new technologies. Sponsors will encourage sites to digitize, but without imposing specific technology or vendor choices. Progressive sponsors might even offer free vendor solutions, allowing sites the freedom of choice. This mandate aims to accelerate site digitization while respecting their preference for technology solutions.

Catherine Gregor:
I anticipate that sponsors and CROs will continue to develop “Digital Mandates,” encouraging sites to adopt digital solutions for key operational workflows. These mandates are expected to respect sites’ autonomy by not enforcing specific software but ensuring digital processes are in place. Sponsors and CROs will likely provide these technologies to sites lacking them, while seamlessly integrating with existing systems at other sites.

Kristin Surdam:
Site enablement has evolved significantly, now focusing on enhancing sites’ ability to manage their workflows and increase efficiency. In the coming year, the emphasis will be on cross-industry collaboration and technology optionality. Recognizing that no single solution fits all, I foresee sponsors and CROs adopting a more flexible approach, enabling sites with a variety of technologies tailored to their specific workflows. Site Enablement Platforms will be crucial in supporting sites effectively, ensuring both site and patient-centric approaches.

Mike Wenger:
A crucial aspect of site enablement will be focusing on ease of use for new technology users. Overcoming the reliance on minimal training for paper-based processes is essential. The evaluation of new technology adoption should consider not just site leadership but also individual research coordinators. They need to see the value in the transition to actively participate in the change management process, ensuring a smoother and more effective adoption of new technologies.

Ryan Jones:
Florence has the unique opportunity to address the challenges posed by disparate best-of-breed tools. Through recent partnerships with organizations like WCG, Greenphire, Yunu, and others, we aim to integrate various technologies into a single interface for site users. This approach not only simplifies workflows but also maximizes the benefits of these tools. Moving forward, Florence will continue to unify the technology community for the benefit of sites through integrations, partnerships, and possibly acquisitions.

Catherine Gregor:
I foresee clinical trial technology vendors, including Florence, forming stronger partnerships to facilitate data, document, and workflow sharing. The upcoming year is likely to see continued consolidation among vendors, leading to more integrated platforms that better serve study sites.

Kristin Surdam:
Florence stands out as a key player in driving the industry forward, particularly in site enablement. As the preferred eISF provider for sites, Florence boasts a user-friendly interface tailored for site workflows. Our commitment to prioritizing sites is evident in our efforts to foster cross-industry collaborations. Through initiatives like Research Revolution and the Site Enablement League, Florence has shown a dedication to bringing together various stakeholders. We have a range of new initiatives planned for 2024 to continue this momentum.

Mike Wenger:
Florence can play a significant role in enhancing site representation to Sponsors and CROs. Typically, Sponsors and CROs engage with sites on a transactional basis, focusing on immediate study needs. Florence, however, can offer a broader, study-agnostic perspective. This unique viewpoint allows us to share ideas across various sites, garner support, and develop comprehensive, effective solutions that benefit the broader research community.