With the global pandemic creating unbelievable challenges and causing interruptions in clinical research worldwide, contract research organizations are taking action, according to Veeva Systems’ latest Annual CRO Report.
Researchers already faced significant pressure to get trials started more rapidly, executed faster and accomplish greater precision than in the past. With COVID-19 on the scene, such pressures have only increased, forcing trial professionals to get creative.
Outsourcing-Pharma recently discussed the Annual CRO Report (available at veeva.com/CROReport) with Veeva Systems’ vice president of Vault R&D Jim Reilly, who talked about the decisiveness and resilience CROs are displaying to help ensure the future of the clinical research industry.
OSP: Could you please share some of the things that Veeva’s latest CRO Report reveals about the impact of COVID-19?
JR: The research shows an industrywide shift to modernize clinical operations as companies steadily adopt advanced applications to streamline processes. CROs are leading the effort, with the majority using EDC, eTMF, and CTMS to run studies and 90% advancing to bring together their clinical landscape.
COVID-19 accelerated the industry’s move towards digital strategies and solutions to keep existing trials on track and start new studies faster. The CROs that already used modern applications were in a much better position to manage the transition to remote work and respond to the pressures of COVID-19, such as enabling digital access to information for study monitors.
OSP: What other challenges have CROs been tangling with in the past year (and recent years) aside from COVID-19?
JR: The biggest challenges reported by CROs are a result of managing studies using siloed systems. We found that 70% struggle to integrate multiple applications, and 60% have problems managing and reconciling trial data. Silos limit visibility into study information, causing delays.
Using disconnected systems also leads to issues with sharing information in trials. CROs expressed a need to improve information exchange to reduce manual processes and speed studies. This isn’t a surprise, as most still use email to send trial information to sponsors (77%) and sites (81%).
These manual methods of exchanging information increase administrative efforts and reduce efficiency. With trial complexity growing, CROs are focused on connecting their clinical operations and improving collaboration in trials.
OSP: You shared that the report reveals CROs have taken measures to streamline execution by adopting new digital technologies. What do you think that says about the resilience and creativity of professionals in the CRO field?
JR: More than half of clinical research today is outsourced, so it is incumbent upon CROs to be nimble and resilient in pursuing change. Technology plays a crucial role in enabling them to deliver high-quality, differentiated services while ensuring compliance.
COVID-19 magnified the CRO spirit to innovate as they quickly embraced digital solutions to enable remote collaboration and decentralized execution. In doing so, CROs improved trial efficiency, expanded patient reach and accelerated studies.
OSP: Why is improving collaboration and methods/technologies for information sharing important for CROs in general, but specifically in the face of the challenges created by the pandemic?
JR: Improving collaboration and information sharing in trials can speed execution. But manual and paper-based methods have been the norm, as 46% of CROs report using paper shipments to share information with sites. The pandemic, however, made speed of the essence. The reliance on manual processes and paper quickly became an unsustainable way to work.
That’s why the industry is coming together to adopt more streamlined approaches to information exchange such as remote monitoring and eConsent. These solutions automate the flow of information for better collaboration and speed in studies.
CROs are seizing the opportunity and embracing connected ways of sharing information with sponsors and sites, a significant positive step for the future of patient-centric digital trials.
OSP: Can you please share why accelerating study start-up is important and some of the advanced methods and technologies trial teams are using to accomplish that?
JR: Study start-up accounts for 61% of total trial lifecycle times and remains a highly manual process, with 85% of CROs using spreadsheets to manage study start-up. This is an area of significant potential to positively impact clinical research and speed the delivery of drugs to patients.
Growing numbers of CROs use purpose-built study start-up applications to streamline site identification, feasibility, and selection. Looking ahead, that trend should continue in the coming years as more sponsors outsource start-up activities to CROs.
OSP: How does the adoption of eTMF (electronic trial master file) technology help CROs streamline their operations?
JR: The adoption of eTMF among CROs has more than tripled since 2014. CROs use advanced eTMF applications to ensure a constant state of inspection readiness, increase efficiency, and lower compliance risk.
Now CROs can actively manage documents in real time, improving TMF accuracy and completeness. The industry has made significant progress in TMF management, and we expect CROs will continue to lead the way.