In today’s technology-driven clinical trials environment, we are seeing more “niche” technology solutions being developed (and implemented) to solve small, yet critical pieces of a very complex puzzle. We call these “point” solutions, and they are quickly becoming a dirty word in the dynamic and changing business of clinical research.
What is the Problem?
Most of these point solutions don’t talk to each other; they require different user credentials with different user interfaces and workflows that cause more administrative work for study teams and sites who are already frustrated with the ever-demanding clinical research study environment. If that’s not enough, many of these point solutions are switched out from trial to trial by using disparate vendors, requiring study teams to start from scratch with each new study: contracting, configuring, approving and then manually updating excel spreadsheets from each technology to track basic study milestones. Nobody wins. Study teams, sites, vendors, and even management are all dissatisfied with the number of lists, trackers, and manuals we require them to use. (Raise your hand if you’ve worked on a study that used a tracker to track trackers…)
How do we solve this problem?
No matter how big a problem is, the simple cow in the ditch problem solving process always works:
1) get the cow out of the ditch
2) figure out how it got in the ditch
3) do whatever it takes to ensure that cow never gets back in the ditch.
However this problem is so complex, and so much has been invested in these point solutions over time, we should probably look at #2 first (how the cow got into the ditch) before we focus on fixing the problem and ensuring we don’t let that cow go anywhere near that ditch again.
So how did the cow get into the ditch?
It’s a complicated and compounding problem that we brought upon ourselves. We work in a fragmented industry, with fragmented departments and fragmented budgets - and are right in the middle of a major change in the outsourcing model. Investments in point solutions that were once deemed to be stable, long term decisions for on -premise technology (like CTMS or regulatory systems) are now seen as legacy dinosaurs that are out-of-date and expensive to maintain. Even so, sponsors continue to evaluate and purchase point solutions to solve single use-case problems without consideration for interoperability, scalability and user adoption. Point solutions in this case could be any of the following: an eTMF, a site feasibility tool, a study start-up application, a training system, a safety letter distribution application, monitor trip report tool, or a patient recruitment solution. In most cases, these point solutions are resulting in more manual processes, more user credentials, more scanning, and more data entry back into the legacy CTMS they purchased years ago to get a simple report they need to manage their studies and sites. Should we continue down this path of “death by double data entry” or evaluate how other industries have solved this problem from the inside out?
Getting the cow out of the ditch…
Now we understand the problem and root cause: we purchased numerous point solutions to manage small aspects of the clinical trial process – then we cobbled them together each time we start a new study and work feverishly to get them configured and tested in time for first patient in. That is a 3-4 month process that is reinventing the wheel each time. We then manually complete account activation forms for each system and export the data into a common excel spreadsheet to track study milestones. This isn’t scalable, costs millions, and infuriates study teams and site users.
How did the banking industry transform itself from the brick-and-mortar local branch model to being the one stop shop for all of your finances and bill payments? Today, most people log-in to one place to pay their bills online, get a reminder when bills are due, a reminder when they are late, and can even set the application to auto-pay their bills on a schedule. Does this have any applicability to our industry? How did the cell phone industry transition from a flip phone for wireless communication to a complete mobile command center where you can complete most of your business and personal tasks anywhere, at any time, as long as your device is charged? (And why do we still even call it a phone?!)
They developed the operating system or platform that manages the infrastructure, security model, and core operating components of the system (phone, text, email, calendar, settings, etc.) and an integrated App model for non-core components (like games, tools, music, etc.). The core components are fully integrated such that the email, calendar, address book, and calendar all update with each other. When an appointment changes on the calendar, your email reminder will update accordingly. The non-core “Apps” are typically downloaded from the App store and operate within the platform, but are not as integrated with the core components.
Is this the right model for the eClinical space? Can this eliminate the problems we have with so many point solutions being adopted? The answers are “yes” and “probably sometime."
Let’s compare the mobile industry “App Model” with the eClinical industry model to determine if we can transition from a point solution model to a platform technology model without significant disruption to the current operating model and in an affordable way.
A platform technology for the eClinical space would start with the Clinical Trial Portal as the platform technology with the following core components: User Administration & Access Control, Secure Email, Calendar, Document Management, Reporting, Central Task List, APIs, and Settings. Optional integrated workflow Apps that are available for any study include: Site Feasibility, Study Start-up, Training, Safety Letter Distribution, eTMF, Patient Recruitment, Visit Reporting and Remote Monitoring. These Apps can be configured in minutes (like downloading an App from the App Store) and will integrate with the Clinical Trial Portal to provide single-sign-on, centralized reporting, and central task management for study teams and sites on a global basis. The central task management is an especially important integration as it provides study teams with one place to go to complete tasks for all of their sites on a given study, or across studies. Third party Apps that need to integrate with the Clinical Trial Portal (such as EDC, IVRS and/or Labs) would use the API core component to facilitate data and artifact transfer to and from the Clinical Trial Portal. The results? Significant reduction in time to configure/deploy, reduction in paper based processes, double data entry, and only one user credential to access all of the Apps. Sponsors win, study teams win, and sites win.
Ensuring the cow never goes back in the ditch
As surprising as it sounds, it is easier for small and mid-size companies to keep the cow out of the ditch than the larger companies. They don’t have the legacy systems or legacy business processes to switch out. They can benefit from leveraging next generation cloud-based eClinical platforms that are configurable to the current need and scalable for the future. This next generation platform technology is designed to operate in an App ecosystem with APIs for integration and interoperability. As new best-in-class Apps become available, they can be added or switched to support the changing needs of the sponsor. As more small to midsize company’s transition to an eClinical platform and App model, they will certainly keep the cow out of the ditch.
Larger pharmaceutical companies and CROs are starting to realize the major challenges these point solution pose and are exploring how and when to transition to a platform solution. However the departmental and budget fragmentation still exists and the business is still actively reviewing and implementing many point solutions to solve their individual needs, without considering the long term impact it will have in terms of integration or manual work. It is always helpful to assign an IT portfolio manager or internal task force who can oversee the eClinical decision making process and provide guidance on the best overall solution for the enterprise and end users and avoid the pitfalls that come with selecting point solutions.
The next generation eClinical companies provide a platform technology solution with integration APIs for workflow “Apps” that are fast to configure, interoperable within the platform ecosystem, and scalable to support thousands of studies. The App model opens the door to add very compelling new applications to the platform to support remote monitoring, integrated grant payment processing, and eSource to name a few. Those companies providing point solutions (eTMFs, Trackers, Training, Safety Letters, etc.) will need to partner with the platform technology vendors in order to provide a solution that actually reduces the manual processes and double data entry for study teams and sites.
To learn more about eClinical solutions, join us at Clintech 2014 (March 11th-13th) in Cambridge, MA.
Lance Converse is the Founder and CEO of ePharmaSolutions. ePharmaSolutions is a leading provider of eClinical solutions that help improve the way trial sites are selected, trained, activated, and managed to exceed enrollment goals. ePharmaSolutions has won multiple Bio-IT World Awards for best clinical trial technology and has activated and trained more than 300,000 clinical researchers in 135 countries for the top 20 pharmaceutical companies and CROs in the world.
(Image courtesy of Hans Splinter via Flickr)