Clinical Ink was recently acquired by GI Capital Partners in a bid to bolster the firm up with the financial fire power so that it can fully execute its agenda to become the industry’s true eSource leader. GI, a leading private equity investment firm, joins existing investor NovaQuest and will continue as a minority investor in the company while the Clinical Ink management team also made a significant investment, exhibiting their intention for long run commitment to clinical trials transformation.
TrialSite provides a break breakdown based on our interview with CEO Ed Seguine.
What was the main purpose of this acquisition?
The company needed to ramp up capital, resources and talent to execute its longer term industry vision of a single-platform solution, challenging the current bifurcated technology reality in biopharma sponsors and their sites. This includes one class of technology that manages electronic direct data capture and the other that involves patient reported inputs such as ePRO, Clinical Outcomes Assessments, etc as well as the explosion of BYOD associated with growing numbers of decentralized studies, especially now in the age of COVID-19 and beyond. Success moving forward isn’t just adding more features but ensuring clients can execute their protocols correctly to make confident decisions faster than ever.
Why is this acquisition a validation of the eSource vision for clinical trials?
Well, because our financials are strong, from revenue to profitability, it adds to the momentum we already had. There are competitors right now that have recently raised capital but it is to try to keep their business alive while they figure out a business model. We have these fundamental problems solved. An acquisition by an investor of this caliber sends a strong message to the market that our position as the eSource leader is clear and accelerates our continued build-out into an operationally mature company. Now it’s the execution of a very important coming together of these different classes of technology so the industry can truly move to 100% digital operations.
Will COVID impact the industry?
Absolutely. COVID-19 obviously put a lot of studies on hold, which has a ripple effect through the industry and has exposed our industry’s weak business model. But that ripple will also lead to positive as the industry now will embrace so-called virtual or decentralized trials.
Does Clinical Ink support virtual clinical trials?
Absolutely. In fact, we can make the case that until sponsors and sites embrace our direct data capture solutions, there will always be paper-based, on site dependencies. Through our long-term, pioneering focus on direct data capture and fully integrated patient engagement, we have built a vast toolkit of solutions, technologies, and supportive industry guidance to support virtual trials.
What is eSource or for that matter Direct Data Capture?
It’s the hardest problem to solve. Most sponsors and sites still face a world where a great majority of source documents/data are created with Microsoft Word templates, printed out and stored at least sometimes in the electronic medical record (assuming a sophisticated site). But this approach is overwhelming paper based and invites errors that lead to protocol deviations and the like. We pioneered eSource Direct-Data-Capture, and it has taken years and many studies to generate the momentum we have but we are in a great place to build upon.
Ed, based on what we know, you are one of the top subject matter experts on the topic of eSource technology: does this matter or can any technology vendor come into this space and develop an offering?
No, its very difficult to just waltz in. The level and depth of understanding must be there and present in the software. It’s easy to simply build an app – but knowing how the data will be used and understanding how sites, patients, CROs, and sponsors all have unique perspectives on the technology and data, is crucial.
So now that you have another significant financial partner, what will be the primary focus?
We now have the financial wherewithal, the expertise and the critical customer mass to accelerate the adoption of our business model at a time when significant challenges exist for many companies including a number of our competitors. Now we will enhance and extend our offerings and innovations later during the year while we also intelligently expand into Asia-Pacific and Europe to support our customer’s global operations.
Ed, this sounds like an exciting time for Clinical Ink?
Yes it is! I’m more excited now than ever before because I can see the momentum building to bring about fundamental change in how clinical trials are conducted.
Why is eClinical technology bifurcated? For example, there are the electronic data capture systems and then the patient centric systems?
Well that’s a great question. Electronic data capture systems at the site are simply designed to collect the data the statisticians need. The EDC doesn’t collect all of the procedures steps involved to follow the protocol, for example, and there are many.
What do sites use today?
What about specialized EMRs we see used by major academic research centers for their research?
Yes, in those cases they may have tools. In many cases, the technology is a decade-plus old. And those technologies aren’t used for sponsor to site productivity but rather for internal investigator initiated studies. It is amazing but true that in a vast majority of cases the site uses paper to run a study. Until that transforms into a digital process, the industry will still have perhaps its most important series of activities still tracked and managed manually.
What are some of the metrics associated with your success over the past few years?
Clinical Ink has refined an offering called the “service-first methodology” and has truly optimized our ability to deliver solutions and support across a wide range of value-added deployment options enabling confident decisions and more meaningful industry adoption. In just the last three years, the company has tripled bookings, quadrupled revenues and backlog grew by 500% as the company’s technology is now deployed across the following:
- 300 studies, in all Phase (I-IV)
- 60 countries in 70 languages
- 50= BYOD studies—decisively more than any other vendor in the market!
Ed we want to congratulate you on all that you have accomplished. You have been a good influence in the clinical trials industry and its impressive how far you have come.
Call to Action: Interested in exploring how technologies such as electronic direct data capture can eventually merge with ePRO, eCOA and other patient-centric data collection in the age of the COVID-19 virtual trial? Contact Clinical Ink.