From The Editor | June 6, 2019

A Platform Approach Simplifies Clinical Workflow For Idorsia Pharma

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

systems design clinical platform

Idorsia Pharmaceuticals Ltd was founded in June 2017 and came about as a result of the acquisition of Actelion Pharmaceuticals by Johnson & Johnson. As part of that acquisition, Johnson & Johnson took over Actelion's commercial products, while the research and development portion of the organization was spun-out into a new start-up known as Idorsia. The company currently has 750 employees and 10 molecules in its pipeline, 4 of which are in late-stage development. Idorsia is active in multiple therapeutic areas, including central nervous system, cardiovascular, immunological disorders, and orphan diseases.

“When we started Idorsia, we had a unique opportunity,” says Simone Mechler, associate director of clinical and quality systems for Idorsia. “We started on a green field, but we also had great time pressures and fixed deadlines. For example, because we were spun-out from another company, we had transition agreements in place stating we could use the legacy systems from the prior company. Unfortunately, those agreements had a fixed end date.”

Designing The Clinical Systems Landscape

Simone Mechler
Idorsia’s problem was unique. Although they had access to systems and trial data, Idorsia technically did not own the systems or the systems landscape. There were different systems in place, and many of them were considered best-of-breed for eTMF (electronic Trial Master File), CTMS (Clinical Trial Management System), EDC (electronic data capture), and document management. These legacy systems were also highly integrated. Still, the transition agreements were good for a period of just 18 months. By the time the agreements expired, Idorsia would have to implement its own platform – and Idorsia even managed to exit early after only 12 months.

“When designing our new systems landscape, we were able to start off with an almost blank piece of paper,” says Mechler. “which is a once-in-a-lifetime opportunity. We were able to consider all available clinical and quality systems that we would need to run our clinical trials, like a CTMS and eTMF. But we also looked at systems needed to house our clinical data, SOPs and work instructions, project and resource management, and something that would handle regulatory requirements and submissions. Compliance was a key concern.”

Early on, Idorsia landed on a strategy which called for a platform approach to the problem. When they evaluated vendor solutions, they did so with the end user in mind. Functionality and usability were features at the top of their requirements list. That strategy also called for minimal configuration and customization. Being a small company, Idorsia needed a clinical & quality systems landscape that was easy to support and maintain. 

“We had a clear IT strategy,” states Mechler. “We wanted to connect information across our entire R&D organization. We felt one platform would best support a variety of functional areas. There were many areas we wanted to cover and felt one platform would bring both synergies and benefits. Finally, we wanted the systems landscape in the cloud and to purchase software-as-a-service.”

Some Important Considerations

Idorsia’s decision meant it would be installing a single platform from a single vendor. While that solution was best for the company, Mechler has a few recommendations for anyone considering this type of approach. First, by selecting a platform approach, you become strongly dependent on one vendor. Doing so requires a solid risk assessment, as the relationship will be very much like a strategic partnership. Take the time to set common goals, ensure you develop the application or the platform together, and do not be afraid to provide input and feedback along the way.

Second, with a platform approach, not every application you get will be best-of-breed. Therefore, make sure the applications most important to you are at the level of performance you desire. Then work with the vendor to make and develop all the systems into what you would like them to be.

Finally, if your recommended solution is software as a service and cloud-based, make sure that strategy aligns with your company’s corporate IT strategy. If your company prefers to keep everything in house, that may require some conversations to convince your business and IT teams.

The Right Solution

The platform Idorsia selected covered clinical, regulatory, and quality application suites on a single cloud platform. Mechler describes it as a unified solution to streamline documents and workflows so teams have a single source of truth across clinical, regulatory, and quality.

Thus far, Mechler is pleased with the end-user experience, which she describes as unique since the system provides one user interface across all systems. “From one area of the homepage, you would access the eTMF and the CTMS for clinical information,” she notes. “from another, you can access documents related to quality, such as CSV documentation or GLP/GMP related documents. And from another you can enter the regulatory document management system, which contains all submission-related documents. It’s a clean user interface and a one-stop shop for end users to get to the relevant systems they use on a daily basis.”

The deadline Idorsia was under also led to this solution. Mechler does not believe they could have completed the implementation in less than a year had they not opted to go with a platform approach.

The implementation was certainly aggressive in its scope. Over 180 users were migrated into the CTMS and eTMF in one effort. The new CTMS absorbed six ongoing clinical trials as well as the legacy studies the company had previously conducted. The eTMF absorbed six closed studies while the document management system received a migration of 300 users and over 40,000 documents. The platform approach also allowed the company to have a streamlined approach to validation documentation, testing, and the setting up of operational procedures.

“Using validation documentation as an example, the platform had one validation master plan, and we had the same approach for all the other Vaults/applications,” says Mechler. “There were a couple of functionalities which we only had to test on the platform level, because it was already being used by the other applications. That saved us a lot of time and effort.”

Significant Benefits For Users

Mechler also faced a minimal integration effort. For example, the platform meant there were no custom interfaces. The eTMF and CTMS are an integrated platform with a single sign-on and interface.  

End user training was minimized because of the ease of use and the fact all systems use the same user interface. Navigation and search functionality were easy to learn and understand. That allowed users to get up to speed very quickly, which was critical considering the short timeframe of the implementation.

“Having the CTMS and eTMF in one application saved end users a lot of time and effort,” says Mechler. “This is due to everything being in one place. For instance, if you sign monitoring visit reports in the CTMS, they will automatically appear in the eTMF. There is cross-linking between documents in the eTMF and the electronic document management system (EDMS) which is part of the same platform. Prior to the new platform, employees had to download documents (like a protocol or an investigator brochure) from a document management system to get them into the eTMF. Now they can be cross-linked between the different applications.”

Updating software to a new version has been simplified, since they are now done at the platform level. Currently there are three major releases per year, and Idorsia can decide what functionality they want turned on.

The platform Idorsia selected was Veeva Vault. By opting for a platform solution from one vendor, Mechler states contracting has also been simplified significantly. In the past, a long list of vendors had to be managed which involved licenses and contracts. Now everything is done through just one vendor partner.