How smart technology is influencing and ultimately improving clinical research

Kyle Hogan, director of eClinical Solutions at Clinical Ink explains how clinical research is benefitting from data collection technologies.

The growing capabilities of data collection using personal computers, tablets, and smartphones paired with direct data capture platforms — like electronic patient-reported outcome (ePRO) systems — are bringing new efficiencies to the clinical research process. The level of convenience for patients, clinical research organisations (CROs), and sites, for example, all rise when ePRO solutions are deployed using a patient’s personal mobile device. Compared to a paper-based diary approach, studies show data quality and compliance from ePRO technologies deployed in a bring-your-own-device (BYOD) capacity can increase as much as 97%.

However, a CRO interested in adding ePRO technology to its portfolio has limited options: build its own solution, acquire an ePRO company, or work with a partner. Each of these alternatives has its own shortcomings. And, regardless of which solution a CRO chooses to use, it will take some time before the CRO sees its investment generate business, benefit patients, and earn financial returns. This article outlines an alternative solution that includes time and cost savings for CROs.

Taking Control

Choosing any one of these methods for delivering an ePRO solution can create silos that make it difficult to access and mobilise data efficiently. Additionally, by adopting an electronic approach, a company may lose revenue that it had previously earned through the implementation and support of its paper-based PRO tools. 

However, there is another solution: a consumption-based business model — one that also flexibly moves control over the deployment, delivery, and support of ePRO from the vendor to the CRO. If structured appropriately, this approach can enable CROs to implement, manage, and support an ePRO solution in-house by licensing an ePRO technology, purchasing support services à la carte, and ultimately creating a new revenue stream.

Successful transfer of ePRO technology requires a delivery model where vendors are willing to price their services separately and charge customers according to their use. In this way, CROs can configure a custom combination of ePRO technology and services that leverage the vendor’s existing resources for support while enabling the CRO to bill for the services it can provide itself, which might include some combination of project management, help desk, configuration, hardware procurement, inventory management and shipping, and support.

Generating Revenue

This approach enables CROs to reduce costs, accelerate study startup, develop an additional revenue stream, and maintain complete flexibility and control over its ePRO deployment. The key to success is finding a partner that offers a cloud-based, enabling technology and an à la carte process that includes a configurable interface. The CRO must also make sure the vendor provides full-bodied, compliant ePRO functionality as well as support, such as with copyright licensing, software, and training.

When managing the technology transfer, it’s a good idea to deploy a well-managed, stepped process customised according to the CRO’s internal capabilities, capacity, and resources. For example, the ePRO vendor initially should perform the work while training the CRO. Then, as the CRO shadows and becomes comfortable, it would gradually assume responsibility, configuring its internal capabilities and resources to manage deployment of the entire end-to-end process. The well-trained and well-prepared CRO would then license the technology and offer ePRO as its own service offering.

Conclusion

The latest ePRO technologies are poised to solve some of the most pressing patient-centric study design needs in the industry. As such, it’s important that CROs find a way to make them efficient, profitable, and easy to adopt. Now is the time for CROs to look ahead and consider the benefits of a consumption-based business model that supports adding a technology transferable solution to their service offerings.