Decentralized Clinical Trials Capabilities and Solutions
Telemedicine enables patients to stay connected to their clinicians, utilizing convenient digital tools that don’t require frequent site visits. Sites can continue their standard of care, reduce protocol deviations, and collect quality data – all with limited interruption.
When patients are unable to visit a site, clinical materials such as samples, supplies and unused investigational medicinal products (IMPs) can be directly shipped or collected from the patient’s home, so study assessments aren’t disrupted, nor are patients’ lives.
Patients can securely review required study documents and provide a digital signature for consent (or re-consent) remotely from the comfort of their homes, so enrollment timelines stay on track, patients are better informed and compliance is maintained.
Home Health Care & Nursing
PPD leverages a network of home health care (HHC) nurses in over 40 countries that enable clinical trials to occur off-site in the patient’s home. This includes the preparation and administration of study drugs, conducting clinical assessments, ensuring eDiary compliance and more.
eCOA and ePRO
Electronic clinical outcomes assessments (eCOAs) and electronic patient reported outcomes (ePROs) use digital platforms to enable direct data collection from study stakeholders. The result is less paper documentation and more timely data, with greater consistency from patients.
When clinical research associates (CRAs) cannot physically be at an investigator site or clinic, remote options are available to generate data analytics, enable remote source data verification (rSDV) and perform other monitoring activities.
Devices and wearables
In today’s research, devices and wearable technologies are generating significantly higher levels of clinical data than traditional trial models. These sophisticated tools – smart phone and tablet apps, sports watches, meters and monitors, garments and textile patches – can be more convenient and less intrusive for patients as sites and sponsors seek higher quality insights.
Our regulatory affairs group provides guidance to support key business decisions around decentralized clinical trials (DCTs). Experts from these teams frequently share informal updates, describing hurdles faced by our industry, related regulatory issues and practical examples of how we manage them at PPD.
See more ways PPD can help with your decentralized clinical trials