Medidata Blog

Avoid a Game of Telephone with a Single Source of Truth In Your Clinical Study

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: interoperability, collaboration, security and privacy, and scalability.

There are 2.5 quintillion bytes of data created each day. That’s a thousand raised to the power of six bytes of data. What’s more incredible is that 90 percent of all the data in the world was generated over the last two years.1 This reality is not too far from our world of clinical trials.

Rapid innovation in the life sciences industry is fueling new drug discoveries and producing large volumes of research data. A 2018 study by the Tufts Center for the Study of Drug Development found that Phase III studies see an 88 percent increase in the number of data points collected.2 Getting drugs to market quickly hinges, in large part, on the collection and sharing of complete, timely, and high-quality data.

In addition to this avalanche of data volume that needs capture and management, there are major challenges plaguing sponsors, CROs, and clinical research sites. Stakeholders lack visibility into clinical trial processes and insights into how trials perform. Data management has become redundant, costly, and resource-intensive.

Trials can be a game of telephone where queries open on data points and change, yet leave stakeholders unaware. But imagine a variation of telephone where the first person whispers a word into the ear of every single person in the room. In this scenario, every player is ensured a single source of truth, a single source of message to repeat out loud. This is exactly what can be achieved by standardized, governed, and mastered data—the basis of a unified platform.

With a unified platform, all parties work within a consistent, end-to-end process and have easy, centralized access to the full set of information in your clinical study. A single source of truth for data gives users and applications access across studies so you no longer need to maintain multiple sites, users, permissions, and access roles. The unified platform helps you make more informed decisions and glean new insights to fine-tune your study objectives and improve future trials. Not only does this streamline operations, it enables greater control, governance, and visibility into audit trails.

Designed with a unified data strategy, the Medidata Rave Clinical CloudTM creates a single source of truth for all study-related data. Simply put, enter data once and let the platform master and populate it throughout the end-to-end suite of Rave applications. Medidata’s pharma and CROs clients gain significant operational efficiencies by reducing data entry and maintenance burdens and by reducing the number of clinical systems needed to run their trials.

Let’s examine a few specific examples of how Medidata Rave Clinical Cloud’s single source of truth enables operational efficiencies for our customers:

  1. Patients can be simultaneously auto-enrolled, consented and randomized in one platform by using Rave eConsent, Rave eCOA, Rave RTSM, and Rave EDC. This ensures that the right treatment is delivered to the right patient at the right time, automatically eliminating the need for multiple data entry.
  2. Study teams can make more informed decisions and gain new insights because Rave EDC captures objective and timely data from all clinical sources for a single data source in all studies. This enables high quality and consistent data in real time.
  3. Clinical operations accurately unify content, data, and workflows from study planning to close when using Rave EDC, Rave CTMS, and Rave eTMF. This minimizes risk and accelerates trial timelines by eliminating multiple data entry for site qualification visits, site initiation visits and site interim monitoring documentation.

 

Check out how our customers benefit from Medidata Rave Clinical Cloud in these case studies and video testimonials:

  • Read how Cancer Research UK benefited from a simple user experience using Medidata’s unified platform in their double-blinded randomized trial.
  • Watch CRO Aperio discuss their decision to unify data and content on Medidata’s unified platform.
  • Watch PhaseBio reveal how they derive insights across multiple studies in orphan drug trials using Medidata Rave Clinical Cloud.
  • Read how Medidata’s unified platform delivers more efficient trial execution no matter the study size.

Listen to Jeff Ventimiglia, vice president of product operations and enablement at Medidata, discuss the five characteristics of a unified platform in more detail in our on-demand webinar.

[1] https://www.forbes.com/sites/bernardmarr/2018/05/21/how-much-data-do-we-create-every-day-the-mind-blowing-stats-everyone-should-read/#28f80d2260ba

[2] Tufts Center for the Study of Drug Development, July/August 2018

 

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