CASE STUDY

Medidata Professional Services Helps
Ambit Biosciences Successfully
Rescue Three Critical Oncology Studies
THE CHALLENGEFULLY TRANSITION THREE ONCOLOGY TRIALS ALREADY IN PROGRESS
Parting ways with a large pharmaceutical partner, Ambit Biosciences waschallenged to fully transition three critical oncology trials already in progress.
Per their agreement, the transition period was to last six months during which
a complete transfer of knowledge, documentation, and data was to takeplace. However, because of its size and limited resources, Ambit found itself
running out of time to migrate the study data and much of the documentation
for the three studies. Additionally, Ambit had just hired a new director of data
management who had been tasked with managing the organization’s electronic
data capture (EDC) system, Medidata Rave®, and all the related data for thesetrials. The director had not been privy to any of the discussions or negotiations
prior to his onboarding but he had to hit the ground running. Fortunately,
he had worked with Rave and Medidata Coder® as well as with Medidata
Professional Services in the past and was aware of the extensive supportMedidata offered that could be leveraged to help successfully transition thesethree studies.

1“The Medidata
ProfessionalServices team maderecommendations basedon our specific needs
and style of working.
Collaborating with themwas easy and I would
recommend them toanyone searching for
top-notch services.
I couldn’t have done it
without them.”
Mar Reyes,
Director of Data Management,
Ambit Biosciences

THE TRANSFORMATION

IMPLEMENTATION OF MEDIDATA’S RESCUE STUDY METHODOLOGY
As part of the transition agreement, Ambit was not permitted to copy theRave EDC URLs. Thus, three new studies had to be created within Rave on anew Ambit URL and all of the existing data was transferred from the previous
databases. Medidata Professional Services helped Ambit successfullytransition the studies quickly and efficiently by focusing on three key areas:zzzMedidata reconfigured the roles and workflows for each of the threestudies to fit the specific needs of Ambit. Ambit’s partner was a large andorganizationally complex pharmaceutical company. Ambit needed fewerroles and more efficient workflows that could be managed by fewer people.
The Rave databases for each study had to be restructured and all of thedata transferred quickly and without error. During the restructuring, theprofessional services team detected elements in the core configuration andmarking groups that had been missing form the original setup.
Once the databases were set up correctly, the data was successfully loaded
using Rave Web Services. Synonym tables used with Coder were createdand uploaded. Medidata provided a level of transparency around the datatransfer process that enabled Ambit to assure the study sites that the data
wasn’t compromised during the transition.

Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company#1

CLINICAL DEVELOPMENTSERVICES

17K+TRIALS100+PROFESSIONAL SERVICES
EXPERTSCASE STUDYz

Medidata Professional Services stepped in to facilitate and accelerate theknowledge transfer. The project manager set up and adhered to a strict
timeline, as all tasks were on a critical path and there was no room fordelays. Professional Services lead the Ambit team step by step througheach part of the transition, providing the sponsor with the available options
at each step and offering recommendations based on their deep rescue
study experience.

Medidata Professional Services worked with Ambit to prioritize the studies
based on level of complexity and developed a timeline for each. The project
manager was able to keep Ambit on track to meet those timelines and tominimize time lost during the transition of the studies. Ambit was provided
guidance as to the documentation they should be requesting and assisted
in securing it before the end of the transition period (e.g., audit trail
documentation).

THE RESULTS

TRANSPARENCY ENSURED A RISK-FREE AND SEAMLESSENVIRONMENT
Medidata Professional Services provided leadership and expertise in not
only getting the customer through the study setup process successfully, butalso doing so within the extremely tight timeline constraints. Additionally, theProfessional Services team drew on their extensive experience across study
phase and therapeutic area and leveraged Ambit’s current infrastructure
to provide a unique and tailored solution based on Ambit’s specific needs.
Medidata Professional Services applied their proven rescue study methodologythat has been developed and refined over many years.

2

ABOUT AMBITBIOSCIENCES
Ambit Biosciences is abiopharmaceutical company focusedon the discovery, development andcommercialization of drugs to treat
unmet medical needs in oncology,
autoimmune and inflammatory
diseases by inhibiting kinases that areimportant drivers for those diseases.
Their pipeline currently includes threeprograms, each discovered internallyand each aimed at the inhibition ofvalidated kinase targets. The leaddrug candidate, quizartinib, is aonce-daily, orally administered FMSlike tyrosine kinase 3, or FLT3, kinase
inhibitor.
For additional information, please visit

ambitbio.com | +1858 334 2100

Ambit realized many benefits through its relationship with Medidata. The
Professional Services team was able to successfully transition the databases,
as they existed with their partner with no apparent data loss. Further, thetransition was fully transparent -providing assurance to the entire study team,including sites, that the process was seamless and reduced risk of error.
Ambit remarked on the depth of expertise provided by Medidata Professional
Services as well as the ease of working with the Medidata team. “The Medidata
Professional Services team lead us through the transition process step bystep and provided us options along the way,” said Mar Reyes, director of datamanagement. “They made recommendations based on our specific needs andstyle of working. Collaborating with them was easy and I would recommend
them to anyone searching for top-notch services. I couldn’t have done it
without them.”

Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences.
Discover more at www.medidata.com and follow us @medidata. Contact us at info@medidata.com | +1 866 515 6044
Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company
Copyright 2021 Medidata Solutions, Inc., a Dassault Systèmes company