Market Overview

Medidata Introduces New Edge Family of Products for Clinical Operations at SCOPE 2018

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Life Science Buyers Identify Top Criteria to Support the New
Generation of Trials

Edge Strategic Monitoring is Only RBM Solution to Address 95% of
TransCelerate Technical Requirements and be Fully Compliant with ICH GCP
E6 (R2) Requirements

As clinical trials become more complex, sponsors and contract research
organizations (CROs) are looking for a unified platform to help them
overcome challenges such as dealing with disparate systems, complying
with new regulatory requirements and managing an increasing variety and
volume of data.

This press release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20180213005857/en/

Medidata Clinical Cloud: One platform for Data Managers, Clinical Operations, Investigators, and Pat ...

Medidata Clinical Cloud: One platform for Data Managers, Clinical Operations, Investigators, and Patients to accelerate the science and business of research.

Today at SCOPE, Medidata
Solutions
(NASDAQ:MDSO) is introducing the Edge
family of products, a holistic suite of intelligent trial planning and
management solutions that seamlessly address today's operational and
regulatory requirements. Edge enables clinical operations teams to:

  • Optimize study design, feasibility and site grants utilizing
    benchmarking from 14,000+ studies
  • Eliminate site escrow accounts with automatic investigator payments
    triggered by EDC
  • Comply with ICH GCP E6 (R2) requirements with an end-to-end RBM suite
  • Utilize master data management for study management
  • Automate the collection of up to 76% of a trial master file

Edge is supported by the Rave
family of products, the most comprehensive data capture and management
solution, and is powered by Medidata
Enterprise Data Store (MEDS) and AI
. Rave allows sponsors to
capture, manage and explore site, lab, imaging, genomic, app and sensor
data, and real world data. Together, they comprise the Medidata Clinical
Cloud®, which is the unified platform of choice for clinical operations
and data management.

In a recent survey conducted by Medidata, life science decision makers
and users identified the capabilities necessary to deliver the next
generation of clinical trials, including EDC and risk based monitoring
(RBM).

The top criteria for EDC are: price, (24%); integration (23%);
robustness of features (18%); intuitiveness of software (18%); and
database build speed (17%). Medidata's Rave EDC is ranked as the top
solution across all criteria.

For RBM the top criteria are: risk identification & evaluation (26%);
issue management & workflow (21%); reporting, analytics, visualization
(21%); targeted SDV (17%); and site visit management (15%). Edge
Strategic Monitoring is the only end-to-end comprehensive suite that
combines risk assessment and anomaly detection with centralized issue
management, enabling users to identify risks and document actions in
real-time while complying with ICH GCP E6 (R2) requirements.
Furthermore, Medidata addresses 95% of the 130 technical requirements
suggested by TransCelerate
BioPharma Inc.

Join Medidata (Booth #800) at SCOPE, Feb. 12-15, in Orlando, Florida.
Additionally, Medidata experts will be speaking on the following topics:

  • Nina Pruitt | Speaker "The Rx for your Clinical Financial
    Management" | Tuesday, Feb 13, 12:05 p.m.
  • Anthony Costello | Moderator "What Is Holding Back The Adoption
    Of eConsent" | Tuesday, Feb. 13 at 4 p.m.
  • Daniel O'Connell | Speaker "Think You're ICH E6 Compliant? Show
    Me The Quality Tolerance Limits" | Wednesday, Feb. 14 at 4:55 p.m.
  • Hrishikesh (Rishi) Karvir | Speaker "Applying Machine
    Learning Frameworks to Improve Trial Outcomes" | Thursday, Feb. 15 at
    9:55 a.m.

The double-blinded survey featured 100 life science respondents from the
US, Canada, and Europe, and was conducted in July 2017.

About Medidata Solutions

Medidata's unified platform, pioneering analytics, and unrivaled
expertise power the development of new therapies for over 1,000
pharmaceutical companies, biotech, medical device firms, academic
medical centers and contract research organizations around the world.
The Medidata Clinical Cloud® connects patients, physicians and life
sciences professionals. Companies on the Medidata platform are
individually and collaboratively reinventing the way research is done to
create smarter, more precise treatments. For more information: www.mdsol.com

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