MID-SIZED AND EMERGING BIOPHARMA

THE TECHNOLOGY AND
EXPERTISE TO SUCCEED
In a highly competitive industry, how you apply your finite resources to accelerate outcomesis critical. Medidata’s 20+ years of expertise with customers and trials of all sizes can help
you stay on the path to success. Mitigate risk by managing your data and workflows in one
place with proven innovative technology supported by a trusted partner at the center of thelife sciences ecosystem.

Together with your CRO, we can achieve our collective mission of extending greater value
to patients and realizing the best possible outcome of trials.

WHY DO MID-SIZED AND EMERGING BIOPHARMA COMPANIESTRUST MEDIDATA FOR SUCCESS?
Tested on over...

A Unified Platform for Studies of Every Size

2.6K Single Site Studies

3%

3K Phase 1 Studies>2000 Patients

20K Trials

Trusted by...
180+ CRO Partners
1.2K Emerging and Mid-Sized
Biopharma Companies

55%<100 Patients

ActiveStudies

900K+ Site and Sponsor
Relationships

Visit medidata.com/mid-sized-biopharma to learn more.

Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company

12%500–2000
Patients

30%

100–500
PatientsMid-sized and emerging companies need
a competitive edge.
Medidata uses industry best practices from over 1.2K
emerging and mid-sized biopharma companies like you toensure efficient deployment and faster technology adoption
to allow you and your trials to advance with agility and speed.

“A lot of sites were happy to hear we were going over to Medidata.”
Patrick Zbyszewski, Director of Clinical Data Management

CHALLENGE• Difficulty screening

patients due tounpredictable eligibility
criteria for rare indication
qualifications of studies

SOLUTION

BOTTOM LINE• Platform offered flexible• Initial selection of Rave
EDC and Rave Coder

control over study buildand design, allowing
Onconova to employ avariety of different models
based on available
resources and costs• Based on success ofplatform and company
growth, Rave RRTSM
and Rave Targeted
SDV introduced• Reduced costs of contracting
third-party builders• Standardized study build

eliminated protocol redundancies
and reduced trial start-up time“Everything is there in one place. We can filter by site, we can filter
by what’s been dispensed, and it’s really easy for us to track.”
Olivia Frank, Clinical Research Associate

CHALLENGE• Randomizing trial subjects• Drug supply management

SOLUTION• Integration of Rave RTSM
with Rave EDC enabled
seamless monitoring

BOTTOM LINE• Intuitive user interface

led to reduced training
time and faster accessto data• Product integrationeasier than originallythought• Faster study start-up“Medicenna, as a small company, we [got support from the FDA for] the very first
design of a Phase 3 registration trial where the majority of patients would comefrom a Synthetic Control Arm®.”
Fahar Merchant, CEO, MedicennaCHALLENGE• Patient recruitment andretention for recurrent
glioblastoma (rGBM)
patients due to thepossibility of being
place in control arm

SOLUTION• Synthetic control arm (SCA®)
formed by carefully selecting
patients from historicalclinical trials to match thedemographic and diseasecharacteristics of patientstreated with the newinvestigational product

BOTTOM LINE
• Precedent-setting
agreement from the FDA
to design a Phase 3
registrational trial usinga hybrid-SCA

Visit medidata.com/mid-sized-biopharma to learn more.
Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company  
Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company• Will reduce the number ofpatients assigned the control
arm while still providing
scientifically rigorous data

• Accelerate trial timelines,

lower costs and enable fasterproduct development