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A basic presentation we use to introduce biotech and pharmaceutical companies to the oncology contract research services Medelis provides to sponsors in the U.S., Europe and Asia.
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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 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