Medidata Blog

The Foundations of a Unified Clinical Platform

Watch our webinar Unified Platform Defined available on-demand to learn the five pillars of a unified platform and how it solves clinical research challenges today and positions your business for the future state of trials. Register now.

This is our five-part blog series on the most important characteristics of a unified technology platform. Read about the other four characteristics in this blog series: collaboration, single-source of truth, security and privacy, and scalability.

Did you know?

  • If a breakthrough HIV/AIDS drug that extended lifespans 14 years had been approved one year earlier, it would have added $19 billion in patient economic benefits and $3.7 billion in additional sponsor profits.1
  • Clinical approval delays can cost as much as $600K in lost sales per day for niche products and $8 million per day for blockbuster drugs.2

Rapid innovation in the life sciences industry is fueling new drug discoveries while producing large volumes of research data. Meanwhile, clinical trial setup and execution continue to be slow, and the time and cost to develop and bring new drugs to market are increasingly onerous. At the same time, higher complexity trials are more likely to require more protocol amendments, add to timelines,3 and increase the impact on patients waiting for critical treatments.

Based on these challenges, it’s time to take a closer look at improving operational efficiencies through the use of a unified clinical technology platform. A unified platform brings people, systems, and data together to form a collaborative, efficient, and effective ecosystem to get the right treatment, to the right patient, at the right time.

To that end, we have identified five characteristics that form the building blocks of a unified platform:

  1. Interoperability
  2. Collaboration
  3. Single source of truth
  4. Scalability
  5. Security and privacy

We’re taking a closer look at each of these essential attributes in a series of blogs, starting here with interoperability.

Part 1: Interoperability

Interoperability in a unified platform enables effective and consistent communication and exchange of data between different and disparate applications, user interfaces and systems, not only between applications of any given technology provider but also across providers. When you post to Instagram, it automatically posts to Facebook—something you expect to happen without any manual intervention; that is what interoperability looks like. As an example of a lack of interoperability, a few years ago you couldn’t use Microsoft Outlook on MacOS without either installing a separate instance of Windows OS or using a VPN connection.

In clinical trials, it’s paramount to share data between technology applications provided by the same vendor and also across vendors. Piecemeal, non-integrated systems, and processes have long plagued clinical trials. Many sponsors and CROs look toward homegrown solutions and vendor point products to streamline specific clinical functions but most fall short in addressing systemic inefficiencies and process-centric challenges.

In a survey of leaders across clinical development conducted by Deloitte,4 respondents said that a typical pharmaceutical company has 30 to 50 technology platforms and clinical systems. A fragmented infrastructure not only hinders collaboration, but also obstructs the flow of data, once again, highlighting the need for interoperability.

Interoperability is one of the key components of the Medidata Rave Clinical CloudTM platform. Through interoperability, our platform brings previously disparate systems and siloed processes together to fuel collaborative, efficient, patient-focused clinical trials from beginning to end. It’s this building block of a unified platform that makes it flexible to adapt to your business processes instead of the other way around. This ensures information and process silos are eliminated, resulting in a seamless movement of data and workflow between applications and tasks. Study teams, regardless of geography or time zone, can access and share data and analytics in real time for unencumbered knowledge sharing.

The Medidata Rave Clinical Cloud transforms the way life sciences companies develop and bring products to market by unifying all facets of the clinical development process, from site selection to trial planning and management, and from data capture to analytics.

See how Medidata Rave Clinical Cloud is helping to re-imagine the study conduct process to improve operational efficiencies and outcomes.

Watch our webinar Unified Platform Defined available on-demand to learn the five pillars of a unified platform and how it solves clinical research challenges today and positions your business for the future state of trials. Register now.

[1] Manhattan Institute, 2010

[2] Cutting Edge Information, 2005

[3] Getz K. The Cost of Clinical Trial Delays. Tufts Center for the Study of Drug Development. 2015.

https://www.ctti-clinicaltrials.org/fi les/pgct-session5.1-getz.pdf

[4] Deloitte Insights, “Transforming the Future of Clinical Development” https://www2.deloitte.com/insights/us/en/industry/life-sciences/digital-research-and-development-clinical-strategy.html

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