Decentralising aspects of a clinical trial through enabling certain procedures and assessments to be conducted away from a site is one important tactic of trial optimisation, with an emphasis on collecting the right data at the right time, using the right solutions in the right setting.
Thoughtful, optimised trial design should consider the number of activities conducted at required site visits and how the visit experience can be simplified for both patients and sites by migrating certain elements to be conducted remotely. This will sometimes, but not always, lead to fewer site visits – however, it will always lead to a simpler experience for all participants.
Advantages of decentralised methods
A clinical solutions partner such as Signant can enable sponsors to run a successful decentralised clinical trial (DCT) as it has extensive global reach with available project teams in all time zones, complete with the global architecture and infrastructure to facilitate trials anywhere around the world.
By leveraging decentralised methods, sponsors and study teams can optimise how evidence is collected, deliver a more empathetic patient experience, ensure speed and enable operation at scale.
Signant Health implements innovative technologies to facilitate remote trial conduct by leveraging full-featured solutions alongside three other pillars for DCT success: science, scale and service.
The global evidence generation company offers end-to-end software solutions such as eCOA, eConsent, and RTSM that optimise evidence generation, trial operation, and the patient experience from enrollment through trial closeout, leaving no surprise capability gaps.
In terms of scalability, Signant has the infrastructure and support teams in place to support any global trial and help you reach patients wherever they are located.
Furthermore, the success of a trial requires an expert team of clinical and scientific experts.
Signant’s 50+ in-house clinicians oversee all aspects of trial design and conduct to ensure trials maintain outcome measure reliability and accuracy regardless of whether trial activities occur at home or at site. They can help a study team enable different measurement settings and approaches, as well as ensure ongoing data quality monitoring.
Signant’s DCT suite offers an integrated, comprehensive randomisation and trial supply management (RTSM) solution to enable remote supply chain management, including direct-to-patient medication provision with full, last-mile traceability.
The implementation of Signant’s DCT solutions is handled by a experienced global project delivery team supported by vital accompanying services, including in-house provisioning and logistics, COA scale and license management, and a 24/7 local language, patient-facing help desk.
One key challenge in clinical trials today is the increasing numbers of data sources. Signant’s data aggregation and intelligence platform addresses this issue by facilitating rapid data consolidation from all sources, which helps enable a 360-degree data review for actionable insights, RBQM, and proper data management.
When sponsors discuss DCT, they are often referencing eCOA. Simply put, eCOA is the cornerstone – it represents the patient-facing solution that collects clinical evidence to derive crucial endpoints, so a robust and reliable solution is essential for trial success. However, other enabling components are important considerations to simplify other aspects of participation such as eConsent, patient engagement, telemedicine, and direct-to-patient medication supply.
As trials continue to increasingly leverage decentralised methods, the industry should approach decentralisation as just one way to optimise future trials. While it is important to reduce site visits, we must also think about how to optimise every aspect of remote conduct to ensure trials collect clinical evidence of the highest quality while continuing to simplify the patient and site experience. With the right solutions, support, science, and service from partners like Signant, we are confident that the DCT adoption curve will continue to grow.
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