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Medelis is a full service oncology

CRO.
We deliver a complete array of
drug development services from
preclinical through marketing
approval.
We can provide an entire solution for
your journey through the drug
development process…
Or we can provide a la carte
services to supplement your
existing resources.
Services include:
Oncology preclinical development
Quality assurance and regulatory compliance
Site identification, qualification, management, contracting &
payment
Medical writing
Protocol development
Document preparation and production
Investigator identification and recruitment
Medical monitoring and management
Oncology patient recruitment and accrual strategies
Now delivers all of our services
for European, US and Asian
sponsors.
Headed by Dr. Deirdre Tessman
30 years of drug development
experience and 10 years
managing oncology trials in the
E.C.
Our approach is driven by our deep
oncology experience and focus…
It extends from our medical founders
to
our CRAs and statisticians.
Our Medical Advisory Board has a
combined 143 years of oncology
drug development experience…
422 INDs and 76 NDAs filed.
Dan Von Hoff, James Gourzis, Michael Gordon, John Balser, Mace Rothenberg,
TGEN Biopharma R&D Premiere Veristat Vanderbilt-Ingram
Consultant Oncology Cancer Center
Our project managers have a minimum
of
8 years of clinical research
Our CRAs have a minimum
experience… of 4 years
of
oncology hands-on experience.
Our medical monitors are
board-certified oncologists.
Our team has hands-on experience
in almost every type of oncology
indication and drug type.
• AML • GIST • Neuroendocrine
• Bone marrow • Glioblastoma tumor
transplant • Gliomas • NSCLC
• Breast • Head and neck • Oral mucositis
• Cervical • Hepatic • Ovarian
• Cervical hyperplasia • Hepatocellular • Pancreatic
• CLL • ITP • Pediatrics
• CML • Leukemias • Prostate Renal
• Colorectal • Lymphoma • Sarcoma
• Endometrial • Malignant ascites • Solid tumors
• Gastrointestinal • Melanoma • Solid
stroma • tumors/lymphoma
Multiple myeloma
tumor • Thoracic indications
• Neuro indications
• Genitourinary
indications
• GI indications
• Alkylating agent • DNA aptamer/intercalator
• Alkylator • Engineered MoAb
• Anthracycline • Fibrin sealant-biologic
• Anti-angiogenesis • Growth factors
• Antibody • Genitourinary indications
• Antisense • Monoclonal antibody
• AntiVEGF/ angiogenesis • Multifunctional polypetide
inhibitor agonist
• Biologic, gene therapy • Oral rinse
• Camptothecin derivative • Tubulin inhibitor
• Chemo • Tumour-VDA
• Chemo/antibody • Tyrosine kinase HER1 inhibitor
• Chemo/radiation • Tyrosine kinase inhibitor
• Diagnostic • Vaccine
We manage our resources through a
single point of contact to build a
strong relationship with your team.
Sponsor

Clinical
Medical
Monitoring

Project
Manager

Safety Data
Mgt Mgt

Site
We have solid relationships with
key academic centers, thought-
leaders and research groups.
• Corporate Affiliations
– TGen TD2, Veristat, NFCR
• Key Opinion Leaders
– All cancer types
– Multiple disciplines
• Academic Centers
– NCI-designated Comprehensive Cancer Centers
• Professional Orgs
– ASCO, ASH, AACR, etc.
• Federal Agencies
– FDA, NIH, NCI
• Cooperative Groups
– ECOG, SWOG, RTOG, GOG, ACoSOG, etc.
We can use sophisticated options like
EDC
and internet-based patient
recruitment
for phase I and phase II trials.
European Operations
France
US Operations
Phoenix, Arizona
US Clinical Operations
Nashville, Tennessee
Headquarters
Reno, Nevada
Data Management
Boston, Massachusetts
To learn more, please contact us
today.

US Corporate Headquarters – Phoenix,


Arizona
Bob Bosserman, President & CEO
(602) 840-1101

Medelis Europe – Port Vendres, France


Deirdre Tessman, Managing Director
+33 0666 622 723

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