Contract research organizations (CROs) must respond to the global COVID-19 pandemic with digital clinical trial solutions to support biopharma companies’ research continuity initiatives as well as provide more infrastructure to ensure patient safety.
PPD is one of the largest CROs in the market and recently touted their digital clinical trial offerings—from electronic patient consent to telehealth to hybrid and fully centralized/clinical trials. Their goal: enable biopharmaceutical companies to advance current and planned clinical research programs.
With the advent of the pandemic, much economic activity came to a grinding halt. Hence, the coronavirus pandemic posed greater challenges to the design and conduct of clinical trials, particularly the inability of some patients to visit impacted research sites when subject to government stay-at-home orders or to avoid exposure risk.
Niklas Morton, PPD’s senior vice president of digital services, commented, “The pandemic’s impact is driving a new consensus that the need is now for expanded use of digitally enabled trials.”
A CROs Response
PPD had long ago been seeking digital strategies for enabling more efficient clinical research. In fact this author was involved with this CRO to undertake a substantial digital collaborative initiative years ago. Hence the company has had a long-term digital strategy and its staff have been collaborating with customers, regulatory authorities, and business partners to deploy innovative digital and virtual solutions.
Capitalizing on Recent Investments & Partnerships
The CRO now markets the sum of the investments and partnerships completed in the last years. The goal: developing new clinical study models that improve patient experience by reducing the number of in-person visits in favor of remote and digitally enabled study participation. The company’s service offerings combine operational solutions such as direct-to-patient and direct-from-patient models incorporating home health care nursing, study drug administration, sample collection, and the pickup and return of study materials; and digital solutions such as eConsent, telemedicine, devices/wearables, and electronic clinical outcome assessments (eCOA), including electronic patient reported outcomes (ePRO).
Examples of Recent Deals: Medable and Science 37
Prior to the COVID-19 pandemic PPD had inked partnerships with Medable and Science 37, two of the key players in virtual clinical trials. Those partnerships were timely given with what has occurred worldwide. The Wilmington, NC CRO now is rapidly deploying solutions to mitigate study challenges given the new realities. These include new mobile applications that enable patients to connect visually with their clinical study sites and allow investigators to better complete safety assessments, plus supporting the capability to also collect eConsent, eCOA, or data from devices/wearables on the same digital trial platform. PPD is deploying trial models that enable or augment, respectively, the use of traditional brick-and-mortar sites with full digital support and decentralization (or virtual) site alternatives to allow the recruitment and retention of patients remotely.
Accelerated Enrollment Solutions
PPD’s AES is leveraging similar capabilities to increase their biopharma company client access to patients by reaching beyond AES’ physical site infrastructure of more than 180 research sites, including rapidly delivering continuity solutions for clinical trials affected by the COVID-19 pandemic, such as telehealth to remotely screen patients and conduct study visits.
Pause for a Reset
Unfortunately, many clinical trials cannot just go digital. There are a number of factors involved from the protocol numbers business and legal matters that must be reviewed and potentially reset. However, the COVID-19 pandemic will force the industry to undertake this “reset” so all facets of a study can be managed in this world constrained by a deadly virus with no cure in sight as of yet.