Medidata’s Rave EDC Solution: All About Value

This blog was authored by Katrina Weigold, Vice President of Global Partners at Medidata. Katrina has grown and cultivated global partnerships at Medidata for over a decade, expanding the reach of the company’s transformative platform for clinical development, commercial, and real-world data.

In the first blog in this series, we looked at the increased complexity of Phase I clinical trials and how an Electronic Data Capture (EDC) system can be hugely beneficial in this early stage. In the second blog, we discussed why an EDC system is so valuable and things to consider when choosing an EDC system provider. In this final blog, we will look at Medidata’s Rave EDC solution and how it can support your study needs—from early-stage trials through post-market surveillance. 

Medidata delivers tailored, flexible, and cost-effective support for sponsors and CROs executing Phase I clinical trials through our unparalleled experience and best practices, conducting over 4,000 Phase I studies for 400 clients over more than 20 years. This is how.

Clinical Trial Cost and Speed

Medidata’s site-based pricing model means we can price appropriately for the budget of smaller Phase I clinical trials. We provide a Phase I-specific, pre-configured, and accelerated EDC implementation service that improves quality and reduces build times because it’s pre-validated and doesn’t require additional customization and testing. The pre-configured library contains: common Phase I forms, fields, edit checks, and custom functions; basic visit structure and dynamics; and lab administration.

Our customers have found that the utilization of standard forms from a predefined library drives faster study build timelines, simplifies data collection, reduces data clean and reconciliation efforts, and results in shorter database lock timelines. In fact, this service is a fit for about 75% of the protocols we evaluate, and most study startups can be accomplished in less than two weeks.

In a recent Industry Standard Research survey, 42% of respondents said Medidata was their most preferred EDC provider for Phase I and II trials (the highest rated provider)¹.

Flexibility for Protocol Amendments

Protocol amendments and incremental changes are implemented with no system downtime. Subject data can be migrated from one form or protocol version to a new version.

For adaptive trials, Rave EDC allows granular control over extensive study design changes by configuring and testing the changes before deployment (with a full audit trail).

Scalable Continuity

Medidata’s Rave EDC easily allows for scalability as a sponsor or CRO moves into Phase II, Phase III, and Phase IV trials, involving more patients and more data. Medidata’s solutions scale to meet the demands of any size—Rave EDC can scale from a few sites and healthy volunteers to mega-trials with thousands of sites and tens of thousands of patients. 

In the same survey mentioned above, Medidata’s Rave EDC was the runaway first-choice preference for all trial types. 40% of respondents deemed Medidata their top pick for Phase I/II, Phase IIb/III, and Phase IV post-marketing trials.

Beyond EDC

Rave EDC is built on the Medidata Clinical Cloud®, a unified, cloud-based platform that delivers streamlined workflows and common data views across multiple clinical development applications, including:

• Medidata eConsent (electronic informed consent) – Whether onsite or remote, Medidata eConsent automates the patient enrollment process and onboards patients directly into Rave EDC, improving overall consent tracking management, reducing informed consent errors, and easing the administrative burden for sites and study teams.
• Medidata eCOA (electronic clinical outcome assessment) – Captures patient diaries and questionnaire responses via mobile devices or a web browser and directly feeds that data into Rave EDC to supplement the eCRF data. Medidata eCOA provides a flexible, intuitive model for capturing patient data that is designed to make it easier for patients to engage in clinical trials.
• Medidata Rave RTSM (randomization and trial supply management) – Drives randomization, dispensation and supply inventory management from the EDC interface and eCRF data. Rave RTSM seamlessly integrates with Rave EDC to eliminate duplicate data entry, reduce reconciliation, decrease administrative burden, and significantly lower risk and cost.
• Additional applications include Rave Imaging, Rave CTMS (clinical trial management system), Rave Site Payments, and more.

Data Security

Medidata was built on safeguarding patient data to enable successful clinical trial execution—and our privacy, security, and quality management expertise are paramount to this success. Medidata’s Unified Protection Strategy includes the company’s information security, data privacy, and quality functions. Together, these functions ensure that Medidata has created a secure, stable, and scalable cloud platform, robust data governance processes, and an inspection-ready quality management system—which, when you put them all together, are critical enablers to success in clinical trial execution.

Medidata is a trusted partner to more than 150 global CROs, partnering with 80 CROs for more than 5 years and 26 CROs for more than 10 years. 

Read the first blog in this series here and the second blog here.

Medidata delivers tailored, flexible, and cost-effective solutions for small to medium-sized CROs. Supporting over 4,000 Phase I studies for 400 clients over the past two decades, Medidata helps its partners attract and win more sponsor bids and execute them successfully with its proven, innovative technology and unmatched partnership experience. Read more about Medidata’s EDC offering here.

¹ EDC Market Dynamics and Service Provider Performance (4th Edition), Industry Standard Research, December 2020.