One of the biggest challenges to working remotely is communication. That’s particularly true of clinical trials that have become increasingly complex as management of these trials has shifted to contract research organizations and technical providers play a greater role. Trials have also moved further away from the pharmaceutical companies that sponsor them.
One IT startup has developed a cloud-based tool to simplify communication and task management between trial sponsor, lead investigator, site manager and service providers in between.
James Denmark is the soft-spoken CEO and founder of myClin. He comes from a background steeped in CROs. He and his colleagues developed the social collaboration platform to manage the different systems and tools investigator site managers use to communicate with the clinical trial ecosystem. Among the tasks the platform can be used for are forum interactions, feasibility surveys, sharing documents, publishing study news and responding to site questions.
The bootstrapped company recently moved from a shared workspace to its own office on Church Street in Philadelphia. After launching its first version in 2010, it introduced its third iteration of the cloud-based platform last year. In an interview with MedCity News, Denmark said about 4,000 to 5,000 investigators use its platform at sites all over the world from India, Eastern and Western Europe, and North America. The company is just beginning to get its feet wet in South America. This year, it expects to add sales positions in North America and Europe to expand its commercial capabilities.
What’s an example of the kind of problems your platform is designed to solve? “[One] element is really getting engagement between the sponsor of the drug trial and all the people working on their behalf in the field. As an industry, we have introduced a lot of layers. … It used to be just a sponsor on the site, then it became a sponsor and the CRO on the site and the CROs became bigger and more structured, so now there are like two or three layers of the CRO before you get back to the sponsor and all the different vendors.
So it’s about keeping them engaged. How do you keep it so they all know each other? And how do you disintermediate so that both the site and the sponsor can cut through all the layers and get their questions answered, make them more connected? How do you help them reach out and touch each other? What we have done is to make the complexities that surround all those relationships and systems a little more manageable for the investigator site. We do that through the social collaboration environment we have created.”
How flexible is it? “As we work with clients, you can make this as brand specific as you want. But you really want to keep the structure more or less familiar so there isn’t a massive learning curve with each site joining the study, so they will know where to find things. The menu options will have similar names and that softer level of standardization often gets ignored … that’s the sort of thing that bubbles up from people’s experience, so having a single platform for that helps us to at least move that standardization even though we don’t champion it directly.”
What have you added to your latest version based on user feedback? Almost every feature we build is in response to a client saying, we use it for x, but what if we were to use it for y? We usually, say, let’s give it a try and see … prototype something rough using the built-in capabilities of the platform and if that works, only then do we incorporate that into our road map as a feature and build it out as a full-fledged capability. A good example is the upcoming release of a Trial Master File (TMF)-ready export capability that can be used to give individual sites a snapshot of the community content for their files.
How do you view what you are doing in relation to other startups? Can it work with other systems? “From my point of view, the most exciting thing would be when another startup says, ‘We are going to build a new service company in the clinical trial field … and rather than building the complete product stack from the ground up, we would like to build it as a set of applications that run [with my platform]. When that happens … that will be when we have started to make a difference and be disruptive in the clinical trial field.”