Author: Anthony Encarnacao, Vice President, Global Partnerships
Snapshot:
- Technological hurdles: CROs face challenges such as user-friendly technology, seamless integration of multiple systems, regional localization, and efficient licensing of questionnaires that can significantly delay trial timelines.
- Persistent Challenges: CROs face ongoing challenges with data management, complex protocols, regulatory compliance, and patient recruitment, compounded by tight budgets and schedules.
- Effective tech partners: Ideal vendors provide comprehensive support, seamless system integrations and strong communication, helping CROs improve streamlining operations and maintaining trial timelines efficiently.
- Holistic Support for CROs: Suvoda offers end-to-end assistance through a single team managing eConsent, IRT, and eCOA solutions, a unified technology platform reducing integration complexities, specialized eCOA licensing and localization services, and a consultative approach, ensuring CROs meet critical milestones and optimizing study deployment.
In our work with Clinical Research Organizations (CROs), we’ve heard from CRO clients about common challenges encountered in clinical trials– like patient recruitment and retention, regulatory adherence, managing complex protocols, and data management. As an integral research partner for sponsors, CROs have the added pressure of getting their clinical trials up and running under tight budgets and timelines.
Clinical trial technologies are designed to support CROs through study start-up and implementation, but too often tech systems themselves can create delays in time-sensitive moments or make things more difficult for sponsors and patients. This makes selection of the right technology vendor crucial for clinical trial success.
Technology-specific challenges CROs face in meeting trial timelines
CROs have shared some common concerns in implementing new trial technologies. While many factors are important in technology implementation, four noteworthy challenges stand out:
- Technology usability: Any clinical trial technology should be intuitive for both sites and patients, and User Acceptance Testing (UAT) is an important moment in technology implementation to test usability. If sponsors, site staff, or CRO personnel identify design or functionality changes during UAT, system redesign and retesting can cause unanticipated delays.
- System integrations: Most trials require multiple tools to run smoothly, including a Clinical Trial Management System (CTMS), Interactive Response Technology (IRT), eConsent, Electronic Data Capture (EDC), and electronic Clinical Outcome Assessment (eCOA). If the integrations bridging these tools are not working properly, reconfigurations may be needed that may delay trial start-up and cause problems during implementation.
- Localization to different contexts: Technology must be adapted for different countries and languages. This is especially true for eCOA, which involves translation of questionnaires, scales, or instruments into local languages and contexts. Managing translation vendors and ensuring cultural relevance can be time-consuming during the already busy study start-up phase, and CROs may not always have the bandwidth or expertise to manage this process.
- Questionnaire licensing: Licensing questionnaires or other documentation for multiple countries adds another layer of complexity. Negotiating with licensors, and subsequently creating questionnaires in the eCOA technology solution takes considerable time and expertise as well.
Overall, these challenges highlight the importance of selecting technology that is both adaptable and robust to keep trials on track for study submission.
What criteria make for a fit-for-purpose technology vendor?
When CROs carefully identify a fit-for-purpose technology stack and work with reliable vendors, they can effectively mitigate these challenges.
Technology vendors should work hand-in-hand with CROs throughout their study, providing scientific expertise and acting as a thought partner through operational consulting and advising on technology system set-up. Ideally, vendors provide their deliverables on-time with high quality data. Service-oriented and fit-for-purpose technology partners can help CROs:
- Improve patient recruitment and retention: Technology vendors with capabilities for advanced analytics, recruitment algorithms, and AI can help identify and recruit eligible patients faster, make it easier for patients to participate in trials, improving trial efficiency, and reduce patient drop-out.
- Streamline vendor partnerships: A CRO working with a high-quality technology vendor for multiple systems can simplify tech sprawl through features like a single authentication to all products with one login interface and standard user experiences that minimize the need for extensive user training. Fewer vendors also reduce the number of relationships to manage, simplifying study setup and minimizing miscommunication risks. Some vendors also provide platforms with streamlined reporting, which helps CROs make quicker decisions while ensuring data accuracy.
- Communicate efficiently: An ideal technology vendor-CRO partnership means established governance structures, regular status meetings, and dedicated points of contact with technology vendors. This strong governance ensures smooth collaboration and efficiency between sponsors, sites, investigators, and CROs, directly contributing to meeting trial timelines.
In essence, effectively partnering with fit-for-purpose technology vendors empowers CROs to navigate and overcome the complexities of clinical trials.
How Suvoda supports CROs in maintaining and meeting study timelines
Suvoda aims to partner with CROs to deliver service-oriented processes and technology so CROs can consistently meet their trial timelines. Suvoda products, processes, and people aim to support CROs through:
- A single team overseeing eConsent, IRT, and eCOA solutions to streamline communication and technology set-ups.
- A single technology platform so system integrations are minimized, reducing implementation complexity and simplifying study operations.
- A single eCOA licensing and localization team to manage and accelerate eCOA set up, enhancing the CRO’s in-house expertise, ensuring sponsors meet critical milestones like Site Initiation Visits (SIV) and First-Patient-In (FPI).
- A consultative approach and thorough requirements gathering to deeply understand CRO trial needs.
- Building eCOA timelines in parallel with IRT within the Suvoda Platform, ensuring critical timelines are met.
With an average IRT build time of 5.4 weeks from URS approval to UAT for complex trials and 0 critical defects, along with a user-friendly interface that makes technology easy to use, Suvoda aims to support CROs to launch studies quickly and efficiently.
For more, listen to a recent webinar from veteran CRO professionals as they discuss how they make the technology decisions for their trials. Watch here.
Author
Anthony Encarnacao
Vice President, Global Partnerships
Suvoda