In recent years, there has been an increasing scope of decentralization in clinical pharmaceutical trials. Various pharma companies such as Pfizer and Sanofi are investing in the emerging concept of virtual clinical trials. The average capital cost of conducting the FDA's standard Phase I/II/III traditional clinical trial is around USD 1.3 Billion. However, virtual clinical trials eliminate the cost associated with site selection and clinical research laboratory setup.
Site visits for patient data collection account for much of the costly and burdensome clinical trial activity today. However, growing availability of remote monitoring technologies reduces the need for site visits. This offers the potential for:
- Substantial cost savings
- Reductions in participant time and travel
- Gains in patient safety and increased quality, quantity and relevance of clinical data
In spite of the above benefits of implementing virtual clinical trials, a fluid landscape still prevails within the supplier landscape supporting pharma companies in executing these trials. There are very few players with end-to-end capabilities, and most of the emerging players are from the US markets. Though FDA has not yet approved virtual clinical trials, currently they are quite supportive of pharma companies testing the waters. Government regulations in the States are favorable of patient data collection, which is a barrier for other regions. Some of the constraints for virtual trials include:
- Risk of data theft through online information sharing by study participants
- Selection of a particular set of patients with specific symptoms through online enrollment
- Lack of awareness about the advanced version of clinical trials
- Government regulations creating hurdles for data collection in some regions
On the other hand, pharma companies face challenges in terms of choosing the right partner with which to test the effectiveness of virtual clinical trials. Hence, there are two approaches pharma companies might adopt:
- Choose service providers who are already front runners and possess end-to-end capabilities. Examples include players like eClinical Health, Science 37, Clinical Ink, QuintilesIMS (MediGuard), Medpoint Digital and SnapMD.
- An alternative approach is a combination of various service providers from different service capabilities, such as telemedicine, data collection platforms and mobile nursing capabilities and services.
Integration of services from different types of potential suppliers from individual buckets could lead to customized and improved output — provided that the suppliers can offer integration of third party services with their technology platforms.