The life sciences industry descended on Boston for the global Drug Information Association (DIA) annual meeting recently, and as a partner to clinical research organizations (CROs) and CRO vendors, emids was there to listen and present.
It was my first time at the event, and I was struck by the sheer number of companies looking to address key challenges facing the industry.
I was invited to share a presentation from the Medidata booth. The Medidata Cloud provides CROs with a solution that serves data managers, clinical operations, investigators and patients. Their unified cloud platform addresses both the scientific side of research, the data capture and management, as well as the business side of research—the trial planning and management.
In my presentation, I discussed what we at emids have observed in our work with CROs and CRO vendors like Medidata. These five observations outline where we as an industry are now and the path to improving the workflows and processes needed for tomorrow’s clinical trials:
1. The industry has been sold a “Best in Breed” promise. Many of the vendor companies serving CROs were started by skilled developers with deep knowledge about specific aspects of the clinical trials process. They have built technologies that address specific aspects, or modules, of that process.
2. Best-in-breed modules have created some messy problems: As great as these best-in-breed modules may be, several different modules from several different vendors are not always ideal for the client. Data has to be pulled into a data warehouse for the five or six different vendors, and some of that data doesn’t integrate. These data problems may cascade through the process, even leading to a clinical trial having less usable participant data because of platform issues.
3. A unified cloud platform offers a better way: A unified cloud platform provides flexibility, efficiency and, ultimately, strategic value to a CRO vendor and client. Some of the benefits, such as security features, big data tools, storage and scalability options, come native to the platforms. The client can choose how to build it out, you aren’t paying for hardware, and you can go to market faster. Strategic advantages come from your ability to collaborate across the enterprise platform.
4. Organizations and their data are siloed: We talk about siloed data, but siloes are more than just data. Silos can be by client, or by geography. In this industry, those silos might span the globe, which means contending with different languages and governmental regulations.
5. You need a unified platform PLUS data governance: To address the clinical trial needs of tomorrow, you need a cloud-based platform as well as a good data governance structure. Without such a structure, having consistent, accurate and reliable data is unlikely. This is what emids has learned in our work inside and outside of the industry. It’s critical to have the highest levels of development talent to help build platforms, but you also need the wisdom and experience of the business and its workflows—understanding data governance in this case—to harness the value of those platforms.
For more insights into data governance for the life sciences industry, read emids’ white paper on data governance.