Simplicity is the Ultimate Sophistication

The eClinical industry has failed to adopt modern technology and business concepts that are proven to help effectively manage large complex projects that involve a significant number of stakeholders, service providers, data, and investment capital.

Today's clinical trials are run on multiple and disparate systems, leaving the sponsor with less control and a burdensome management challenge. Sponsors are often pulled in multiple directions and are required to leverage numerous solutions, from many vendors, and independent vendor systems, for various trial functions (such as electronic data capture, randomization and drug dispensing, clinical trial management systems, safety, etc.) to manage and support their trial. This results in clinical trial data being distributed on many disparate data repositories with no common management platform for the complex project.

The headaches and painful process involved with managing several different vendors that meet different needs for a single trial has created a barrier to providing sponsors and CROs what they really want-control and access to their clinical data. The hassle and frustration with managing the army of vendors for a single trial has become an increasing concern. That is the current state of our industry, but we can envision a future that alleviates this growing problem.

The future eClinical platform must provide the sponsor with one operating platform that serves all trial technology, sourcing, and resourcing needs. Sponsors will have all the eClinical technology tools at their fingertips, in addition to being able to leverage and manage the various stakeholders supporting their trial.

A single operating platform for clinical studies has several benefits to both platform providers and sponsors. First, the ability to focus all developmental efforts toward continual platform improvement allows for faster, more impactful technology releases to meet customer needs and the constantly developing requirements of sponsors, sites, users, and federal guidance. Second, a single electronic data platform will lead to significant reduction in the study configuration cycle time. Currently, the effort and time spent in attempt to create the illusion of a single platform and to create the many system connections drastically impacts timelines. With a reduction in effort and time required to configure studies, the benefits to cost and timeline reductions are shared between eClinical provider and sponsor. Thirdly, a single platform provides sponsors one stop for more than just clinical trials: site training, industry news, financial information, recruitment, and metadata could all be accessed through one common platform.

This concept presents a paradigm shift in the industry where instead of having to operate a portion of a trial on the stakeholders system, stakeholders will deliver the service on your platform. The platform becomes a virtual marketplace for service exchange where you can identify the services you need from service providers that are willing and able to deliver on your platform. Mix and match not only system functionality but a constantly evolving list of trainings, automated translation service, and even database construction consultation and support. Track and assign generic or custom created trainings for sites, ensure data quality by giving access to a library of training videos and on-demand services to review the program solutions.

Waiting weeks for quotes for trials is no longer necessary. A single system can promote a stable pricing structure, because the need to cover expensive custom work to deal with multiple systems is removed from the equation. Reviewing real-time metadata for programs or specific trials should be imbedded to allow organizations the ability to quickly make budgeting and financial decisions.

Our industry currently requires several experts, each with an understanding of a specific system used for each element. One platform that can meet randomization, data capture, patient reported outcome, inventory management, adjudication, and other study needs requires a single point of contact to configure and deliver these trials. This change impacts the complexity and costly study delivery groups that are currently used. The future system should be simple enough for a beginner to use, and robust and trusted enough to handle the complexities of nearly any trial. Instead of relying on a team of programmers, a brief training course can empower employees with the ability to deliver trials the way the company wants.

For this future platform to be successful, it is important to "utilitize it"-make it as reliable, available, consistent and as easy to use as the utilities that serve our homes. No one teaches us how to utilize our electricity or our water; open the faucet and water runs out; plug something into a socket and it'll simply light up each and every time. We've seen this with technology companies as well. Amazon and eBay don't have new-user training. Human factors designed for intuitive operation is a science that needs to be factored into every aspect of this technology. Every user, be it a patient, a site, an expert or a clinical operations specialist should all be pulled into the platform via notifications over a modality of their choice (e.g., phone, mobile alerts, and e-mail) if and when they need to take an action. Whatever they have to act upon needs to be clearly identified and the process to complete their task intuitive and streamlined.

The untapped potential of a single eClinical platform, along with a certain critical mass of sponsors, sites and service providers on the platform creates unprecedented value. This value exists through its user-base which represents multiple roles, skill sets, experience, and responsibilities. Leveraging proven "social media" models will allow all platform users to satisfy their needs: help patients and sites find trials, sponsors find sites; sponsors find monitors, and much more. This concept would completely alter patient and site recruitment.

The future eClinical platform must provide the sponsor with one operating platform that serves all trial needs.

Zaher El-Assi is General Manager, eClinical Solutions at Merge, e-mail: zaher.el-assi@merge.com.