Clinical Document Exchange Portals: Trendy or Revolutionary?

Clinical trial inefficiencies have been well documented and are commonly cited as one of the main drivers of the escalating cost of drug development. So while the discussion around pain points in developing drugs isn't new, we are only now starting to see solutions emerge. The most recent significant development came from the non-profit TransCelerate, which plans to unveil a shared investigator portal accompanied by an outline for new technology standards that foster interoperability.

Kevin Wojcikewych

Portal innovation is also coming from vendors which offer portal products with a variety of functionality. Even some contract research organizations (CROs) have launched portal products-recognizing the inherent benefits of reduced study start-up time and more efficient processes for themselves and their customers.

The question then becomes, what do the trial sites want? According to a 2013 site survey by CenterWatch and Intralinks, 80% of respondents said they would find value in a single-login trial web portal that allowed access to multiple sponsors. In 2011, a similar survey conducted by the same parties found that 73% of sites were still using traditional communication methods-email, fax, and courier-as their primary tool for exchanging clinical trial documents.

With study inefficiencies still present, and sponsors, vendors, CROs, and sites presumably on board, the industry is still quite early in the adoption of investigator portals despite the promise they hold. The following are some of the most impactful benefits investigator portals can provide to both sponsors and CROs.

Online Site Profile & Registration

Sites and site staff, through a single sign-on, enter required information and upload key documents just one time during study initiation. This information is then used to prepopulate documents downstream, and can be used for future and ongoing studies. Only a small validation step would be needed to ensure the information is current. Benefit: Reduced cycle time during site start up.

Secure Document Exchange with eTMF

Manually tracking the status of required site documents wastes a considerable amount of time. It can be days before a CRO or sponsor realizes a document is missing. Additional time is then needed to collect the forgotten document. With a secure document exchange, sites are proactively notified of missing information. This "trigger" can also dramatically reduce the time needed to get a site qualified and activated. Benefit: an estimated 20% reduction in document collection/maintenance costs.

In addition, all documents can be stored and accessed through the electronic trial master file (eTMF), as opposed to having hard copy files at the site. This cloud-enabled "virtual document binder" would serve as the single source of site documents, reducing the need for clinical research associates (CRAs) to reconcile site files to the eTMF during a site visit. Benefit: an estimated 10% reduction of on-site CRA time.

Integrated Learning Management System

As the industry becomes more willing to standardize training across sponsors and CROs, an integrated learning management system (LMS) not only reduces the administrative time needed to track where sites are within the compliance process, but also in potentially limiting the need for duplicative site trainings. Additionally, an integrated LMS could eliminate training duplications from previous studies by automatically tracking who has received certain training. Benefit: reduce CRO or sponsor efforts and costs of training administration and compliance by an estimated 25%.

Kevin Wojcikewych Senior Director, Business Optimization, Novella Clinical, E-mail: kwojcikewych@novellaclinical.com