Medelis is a specialty CRO that focuses on oncology clinical trials from Phase I to Phase III. It prides itself on building strong client relationships and delivering oncology expertise at every stage of a clinical trial, from protocol development to site management and medical writing. Medelis employs highly experienced operational staff with extensive experience managing oncology studies, and provides dedicated and flexible project management for each client's trial. Its goal is ensuring clients' success through innovative solutions and cost certainty throughout their studies.

1. A SPECIALTY CRO
for Phase I – III oncology trialsClinical answers, faster.Clinical answers, faster.
www.medelis.com

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Overview
4/5/2016
Medelis is a specialty oncology CRO that takes pride in building strong relationships with our clients.
Founded in 2003 by a group of
experienced clinical research
oncologists like Dan Von Hoff and
Michael Gordon, we deliver
oncology expertise at the strategic
and tactical level – from protocol
development and regulatory
guidance to site management and
medical writing.

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Expert Guidance
4/5/2016
Board members are actively involved with our study team
providing expertise in:
Study design
Site selection
Patient populations
The latest trends and ideas in oncology drug
development
Regulatory guidance through FDA and EMA
Strategic expertise… available when needed.

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Operational Oncology Expertise
4/5/2016
Oncology trials are complex. You need an entire team of qualified experts that knows how to handle the
intricacies that arise during an oncology clinical trial.
We are not a training ground for people just starting in clinical
research, or even oncology.
All of our operational resources are highly experienced and have
proven experience in oncology studies.
www.medelis.com

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Experience Quantified
4/5/2016 www.medelis.com
All clinical operations team members have
at least 10 years
of hands-on experience managing clinical trials
15 years
average length of experience
Our clinical operations team has managed
over 425
clinical trials
over 200
oncology studies
are nurses with oncology training (and many
are former oncology study coordinators)
are physicians and former investigators with hands-
on research experience in managing and evaluating
safety in clinical trials
80% of CRAsOur medical monitors
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Operational Approach
4/5/2016 www.medelis.com
Dedicated project manager for the entire duration of
your trial
Act as a true extension of your team
Flexibility to adapt to and integrate into your team,
processes and systems

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Operational Approach
4/5/2016 www.medelis.com
Relationships are our #1 priority
Our client’s success is our primary focus - partnerships
breed success
We're not the large CRO that cycles people through trials
and foregoes developing relationships

8. 8
Bid Philosophy
4/5/2016 www.medelis.com
We don’t provide a lowball bid… and
then create change orders throughout
the trial
We bid on the units and services
necessary for the success of your trial
We won’t submit a change order
unless you change the scope of the
trial

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What This Means for You
4/5/2016 www.medelis.com
Deep oncology experience at each level of your trial
A dedicated project manager
Cost certainty… and unit pricing enables you to quantify costs should
study assumptions change
A proactive and innovative team that anticipates challenges and presents
solutions
A flexible approach… for those times when your goals change midstream
Flexible billing
Cost savings via fixed price, time and materials, unit costs, low overhead,
billing only direct personnel… and no change orders

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Services
4/5/2016
Sponsor Communication
Study Coordination
Manage Trial Status Reports
Timelines
Budgets
Training
Investigator Meetings
Resource Management
Vendor/Provider
Management
Investigator Grant
Management
Trial Master File
Patient Registration
Negotiate Investigator
Contract & Budgets
Develop Data Monitoring Plan
Conduct Site Training
Site Management
Monitor Subject Enrollment
Manage Site Communication
and Trial Related Issues
Conduct Interim Monitoring
Visits
Evaluate Patient Eligibility
Adverse Event Monitoring
Monitor Drug Accountability
Trial Closure
GCP Quality Process
Site Payment Admin
Feasibility
Investigator Identification
Site Qualification Visits
Regulatory Document Collection
and Review
Budget Negotiations
Contract Negotiations
Evaluate Patient Eligibility
Therapeutic Training of Team
Monitor Patient Safety
Periodic Coding Review
24/7 Medical Coverage
Data Monitoring Committees
Develop Safety Plan
SAE Reporting
IND Safety Alerts
Project Management
Site Management &
Monitoring
Study Start-up
Medical Monitoring &
Safety
Quality Management

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Services
4/5/2016 www.medelis.com
Review and reconciliation of
complex data: PK, biomarkers,
imaging and other lab data
SAE reconciliation
Clinical review of patient profiles
Narrative review
Review of endpoint assessment
Statistical output review
Protocol deviation review
Sample size calculations
Randomization schemes
Study Design and protocol
development
Statistical analysis plan
Statistical programming using
SAS
Statistical analysis
Statistical reports
Statistical consulting
Statistical representation at FDA
meetings
EDC services provided using
Phase Forward’s Inform EDC
platform
Database build
eCRF development
Edit check programming
Master user list setup
Portal setup
User training
IRT integration
Clinical data management
EDC developers have built >35
trials
CDMs average >10 years
industry experience
Protocol development
Investigator’s Brochures
Informed Consents
Clinical Study Reports
SAE Narratives
Annual Reports
INDs and other regulatory
documents
Expert Clinical
Data Review
Biostatistics
Data
Management
Medical Writing
Quality Management

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Experience
4/5/2016
Deep experience managing Phase I through
Phase IIIs in the United States and Europe
Public & Private
Biotech & Pharmaceutical
Large & Small Governmental
Academic & Institutional
Full service or a la carte project based-work
Experience in almost every oncology indication
Specialization in complex studies

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Company
4/5/2016
Boston, MA
Nashville, TN
European HQ - France
Founded in 2003 by experienced
oncology clinical research
physicians
Full service or a la carte, for phase I
through phase III oncology trials in
US and Europe
Highly experienced oncology team
members and consultants
Solution providers for design and
implementation of innovative,
complex oncology clinical trials

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David Fox
Vice President, Client Services
(615) 724-4004 david.fox@medelis.com