Medelis Oncology CRO Services

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 complianceSite identification, qualification, management, contracting &

payment Medical writing

Protocol developmentDocument preparation and production

Investigator identification and recruitmentMedical 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 Tessman30 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.

Mace Rothenberg,Vanderbilt-Ingram Cancer Center

John Balser,Veristat

Michael Gordon,PremiereOncology

James Gourzis,Biopharma R&DConsultant

Dan Von Hoff,TGEN

Our project managers have a minimum of 8 years of clinical research experience…

Our CRAs have a minimum of 4 years ofoncology 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• Bone marrow transplant

• Breast• Cervical• Cervical hyperplasia• CLL• CML• Colorectal• Endometrial• Gastrointestinal stroma tumor

• Genitourinary indications

• GI indications

• GIST• Glioblastoma• Gliomas • Head and neck• Hepatic• Hepatocellular• ITP• Leukemias• Lymphoma• Malignant ascites• Melanoma• Multiple myeloma• Neuro indications

• Neuroendocrine tumor• NSCLC• Oral mucositis• Ovarian• Pancreatic• Pediatrics• Prostate Renal• Sarcoma• Solid tumors• Solid tumors/lymphoma• Thoracic indications

• Alkylating agent • Alkylator• Anthracycline• Anti-angiogenesis • Antibody• Antisense• AntiVEGF/ angiogenesis inhibitor• Biologic, gene therapy• Camptothecin derivative• Chemo• Chemo/antibody• Chemo/radiation• Diagnostic

• DNA aptamer/intercalator• Engineered MoAb • Fibrin sealant-biologic• Growth factors• Genitourinary indications• Monoclonal antibody• Multifunctional polypetide agonist• Oral rinse• Tubulin inhibitor• Tumour-VDA• Tyrosine kinase HER1 inhibitor• Tyrosine kinase inhibitor• Vaccine

We manage our resources through a single point of contact to build a strong relationship with your team.

Medical

SafetyMgt

Site

DataMgt

ClinicalMonitoring

Sponsor

Project Manager

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 OperationsFrance

US OperationsPhoenix, Arizona

US Clinical OperationsNashville, Tennessee

HeadquartersReno, Nevada

Data ManagementBoston, Massachusetts

To learn more, please contact us today.

US Corporate Headquarters – Phoenix, ArizonaBob Bosserman, President & CEO

(602) 840-1101

Medelis Europe – Port Vendres, FranceDeirdre Tessman, Managing Director

+33 0666 622 723