Guest blog by Torsten Friedel & Djenan Ganic, Directors at Intilaris LifeSciences
In the digital era there is no place for departmental or data-based silos in any aspect of life sciences R&D, or for each clinical trial to be managed as a start-from-scratch project.
Yet, incredibly, this remains standard practice for the vast majority, if not all, study sponsors and their CROs – and it is compromising their speed to market and their cost efficiency. Instead of learning from similar studies and experiences that have gone before, teams find themselves navigating the same issues and coming up against the same barriers time after time.
This is because their clinical trial management systems are only capturing immediate details such as current trial activities and the people involved. They are not logging the wider experiences so that these can be linked and compared with the designs, parameters and outcomes of other trials. So when another comparable use case or new indication emerges, teams have to go back to square one. They cannot easily build on what has gone before.
It doesn’t have to be that way.
Breaking down barriers to knowledge
Secure, cloud-hosted platforms that support seamless data exchange between linked teams and applications are paving the way for more collaborative and cumulative ways of working - promising to remove a lot of the repetition and resource waste that still goes on today.
We’re already seeing greater alignment between R&D applications, including more fluid data-sharing between clinical trials management systems (CTMSs) and electronic trial master files (eTMFs), which offers a glimpse into what’s possible. But for the full benefits of digital information compilation and activity tracking to be realised, research organisations will need to cultivate a shared knowledge resource and collaboration capability that extends from the definition of a compound to the execution and monitoring of a trial – and which can be added to and called on repeatedly over time.
In the future, we envisage trial sponsors and their CROs being able to tap into this clinical operations-wide resource (as their respective access rights allow) - so that the sponsor can maintain strong oversight, and the research partner can run trials with a new level of efficiency, informed by everything that has gone before. A ‘digital twin’ – representing all trial activity in digital form – will provide an easy way to navigate all content, in the context of each given process. Everyone will be on the same page, with everything they need at their fingertips at each step. (The ‘digital twin’ theme is one we will return to in a future blog.)
Paving the way to a more joined-up future: the CARA Life Sciences platform
Progressing to this digitally-transformed future state, in which all clinical operations processes are connected and able to share data and insights, isn’t the uphill battle some might imagine.
The first step is making sure that all information and knowledge is captured or created from the outset as a structured digital asset, in executable form, both to support the particular processes they inform and so that this core data can be enriched over time, ready for its next use. The benefit being to hone and accelerate new drug development.
It’s as a central part of this vision that Intilaris has partnered with Generis and its CARA Life Sciences platform – one of the very few to support easy data exchange between linked applications without the need for special integration or a dedicated interface.
This means life sciences companies can start to work towards greater cross-organisation and even intra-organisation collaboration, in which definitive, up-to-date data, documents and knowledge can be readily accessed and called into play within the context of a given task or process.
This paves the way for accelerated, optimised workflow.
Additional market drivers for all of this include the adoption of new study designs, including decentralised trials with digital end points in place of the traditional scenarios involving physician interviews and questionnaires to measure treatment progress. Also, as medical devices come to play an ever more important role as part of treatments, adding to the complexity of trial activity, the role of a standardised set-up that promotes the ability to learn and apply historic knowledge from trials becomes increasingly valuable.
To align themselves with all of these possibilities, research organisations should look to start capturing more holistic information, for instance about the design of their trials, filling in the context in which particular results and outcomes were elicited. The richer and more rounded the knowledge base that’s created, the greater the potential will be in future to apply intelligent search/AI-enabled analytics - to better determine new trial feasibility, to spot and avoid previous problems, and to replicate and build on former successes.
Torsten Friedel & Djenan Ganic are Directors at Intilaris LifeSciences, a Clinical Development Consulting company based in Switzerland which bridges clinical science and operations through optimal processes. Intilaris is a strategic partner of Generis, whose CARA Life Sciences platform provides the basis for seamless, standardised data and knowledge exchange between different teams, processes and applications.