More and more, pharmaceutical and biotechnology companies are viewing clinical research organizations as consultative partners in their efforts to successfully navigate the complex pathway of drug development. As the landscape evolves, sponsors need more flexibility in how and what they turn to CROs for to stay equipped to effectively design and execute their studies. This may include both on-site and decentralized solutions.

Sponsors need to first maximize the potential of their in-house expertise, capabilities and solutions and then, determine what they may need from an experienced external partner. As these aspects can change at any given moment, it is vital CRO partners stay agile, flexible and ready to adapt to the sponsor’s unique resourcing needs, offering tailor made approaches and solutions that meet them where they are in their journey.

Flexibility in trial management is a prime example of how sponsors could use tailored approaches to accelerate and optimize trials, working hand-in-hand with their CROs to fill functional gaps where needed most. At IQVIA, often, we see that sponsors may prefer to maintain trial oversight in-house via company experts and resources while relying on our Functional Service Provider Trial Management experience to gauge how best to integrate our wide spectrum of clinical services into the management plan. As trial management covers so many aspects, IQVIA’s FSP team aims to support sponsor partnerships by pinpointing critical functional gaps in trial programs and matching those areas with expert functional resourcing that is scalable and can be seamlessly integrated into the work. Trial needs and business goals will obviously evolve, and the team can offer flexible resourcing capabilities that can be adjusted accordingly. Noted below are key areas sponsors may need trial management support.

Strengthening site partnerships, diving deeper into core trial program challenges

The Clinical Research Associates’ role and responsibilities are continuing to evolve due to a growing transition to remote interactions with sites as we move more towards centralized monitoring. In understanding the importance of actively listening to sponsors regarding their needs, CROs can help sponsors and sites by making sure sites remain engaged despite what may seem like less face-to-face time with CRAs. In fact, in traditional ways of working, CRAs may physically be onsite but only spend 10 to 15% of their time working with the site coordinator and approximately 3% directly with the Principal Investigator. Most of their time may go to time-consuming tasks, including manual inputting of data from multiple sources, electronic case report form corrections and reviewing drug accountability (e.g., product log, storage and usage) with pharmacists.

By integrating tech-enabled solutions, centralized monitors can focus on all remote-based activities while site CRAs can then dedicate their time to focus on enhancing site engagement not only through target onsite visits but also through platform-based messages, phone calls and video conferences, not on administrative responsibilities.

More frequent and meaningful touch bases with the site regarding specific action items can help add value to the trial process, allowing CRAs to build key relationships with site staff on the ground level. Closely working with sites, this deeper level of insight into areas of concern, including safety or regulatory issues, can be raised with investigators, study teams and sponsors for quicker resolution. For example, in opening communication lines with CRAs, recruitment challenges that delay trials and create unnecessary costs may be discussed and sponsors and CROs can work to determine what solutions can optimize activities (e.g., integrating Clinical Trial Educators).

Getting trials off the ground and running efficiently to ensure study start-up activities go as planned, sponsors may rely on CROs to leverage their established and varied expertise and tech-enabled systems to fill critical gaps in in-house resources. While sponsors focus on building their teams for overall trial management, CROs can step in during study feasibility and set up phases to implement necessary operational processes and related training with optimization in mind.

With increasing global trials and related regulatory updates per country and region, sponsors may find it difficult to manage these impactful changes alone. Some are turning to CROs who by nature have wider footprints and therefore have extensive and established knowledge across various trial programs and therapeutic spaces to provide guidance on how best to ensure regulatory compliance without unnecessary trial delays or amendments. From local-level to country-specific or regional, managing varying regulatory guidance and activities, IQVIA FSP experts can help sponsors keep on top of updates and navigate through questions and considerations for effective trial operations regardless of site location. For example, if sponsors are interested in conducting a trial in Africa, it is vital to have insight into specific country requirements (e.g., licensing processes and vendor selection). Whilst in Europe, it is now essential to have knowledge of EU CTR requirements and tangible experience in related application submissions. Over time, as sponsors gain that regulatory knowledge and experience, IQVIA FSP experts can take a step back on guidance and execution in a flexible partnership.

Many aspects of drug development are unknown, but it is evident that sponsors may need expert support in various aspects of trial management that enhance their overall oversight strategy.

Working with a CRO partner who is ready and equipped to provide the functional resources as needed and at scale can be critical to trial success. As needs change over time, having flexibility in how to leverage functional resources to effectively plan and execute trials can be valuable.

Through a collaborative partnership, IQVIA FSP Trial Management is experienced having the right resources in place to accelerate speed and efficiency of trial programs and keep costs at bay, ensuring CRAs play an integral role in enhancing site engagement and help resolve some of the biggest roadblocks to development success.

Learn more about how our team’s deep FSP experience and world class best practices can provide your teams with long-standing development support and optimize your trial programs as they evolve over time.