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 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, TGEN

James Gourzis, Biopharma R&D Consultant

Michael Gordon, Premiere Oncology

John Balser, Veristat

Mace Rothenberg, Vanderbilt-Ingram Cancer Center

Our project managers have a minimum of 8 years of clinical research Our CRAs have a minimum of 4 years experience… 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 • 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.

Sponsor Clinical Monitoring

Medical Project Manager Safety Mgt

Data Mgt Site

We have solid relationships with key academic centers, thoughtleaders 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