As a response to the ongoing global COVID-19 pandemic, PRA Health Sciences has announced the expansion of its Mobile Health Platform for remote clinical monitoring, adding several new capabilities that address sponsor needs for COVID-19 virtual study support. A press release states that the Mobile Health Platform (MHP) engages with patients wherever they are.
The app-based platform allows sponsors to do everything that’s possible in a physician’s office or clinical site, virtually. The new capabilities added to address COVID-19 are designed to support clinical trial sponsors and sites participating in clinical studies by allowing them to connect and coordinate with patients who are no longer able to travel to sites due to the current pandemic. Additionally, the mobile app can also be deployed to transition existing traditional, paper-based studies into more decentralised, siteless studies so that medical care and the evaluation of patients can continue during critical study timeframes.
The mobile app features an administrative web app for investigators and sites, and a downloadable mobile app for patients, enabling sites to:
- eConsent/re-consent patients for use of the mobile application
- Collect consent forms from patients to allow for delivery of investigational product through a third party courier
- Remotely schedule and conduct video consults with patients
- Leverage mobile survey tools to provide real-time insights to study investigators for potential action
Kent Thoelke, executive vice president and chief scientific officer at PRA Health Sciences, says: “As the COVID-19 pandemic continues, it will be increasingly difficult for patients to see their medical professionals in person or adhere to clinical study protocols requiring visits to sites and hospitals. Equally challenging and difficult is the ability for sites to keep up with both trial patients as well as COVID-19 patients. This mobile and remote solution allows critical studies to continue, where protocols and regulatory guidelines permit, and ensures that patient safety and well-being can be maintained during a time when social distancing and relieving the burden on our healthcare system is important in fighting COVID-19.”
The mobile app has the ability to gather electronic informed consent and e-signatures, and complete patient reported outcomes—right from the patient’s personal phone or tablet. Using connected devices, the app also can collect home healthcare data and serve that data into the source for the clinical trial.
PRA’s Mobile Health Platform is built with each specific trial in mind and can be rapidly deployed in as little as one week or less. Depending on the disease state, the patient population, and sponsor targets, PRA’s clinical technology experts will help determine what features are most applicable for each particular hybrid or decentralised trial.