![Page 1: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/1.jpg)
![Page 2: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/2.jpg)
Medelis is a full service oncology CRO.We deliver a complete array of
drug development services from preclinical through marketing
approval.
![Page 3: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/3.jpg)
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.
![Page 4: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/4.jpg)
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
![Page 5: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/5.jpg)
Now delivers all of our services for European, US and Asian sponsors.
![Page 6: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/6.jpg)
Headed by Dr. Deirdre Tessman30 years of drug development experience and 10 years
managing oncology trials in the E.C.
![Page 7: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/7.jpg)
Our approach is driven by our deep oncology experience and focus…
It extends from our medical founders to our CRAs and statisticians.
![Page 8: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/8.jpg)
Our Medical Advisory Board has a combined 143 years of oncology drug development experience…
422 INDs and 76 NDAs filed.
![Page 9: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/9.jpg)
![Page 10: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/10.jpg)
Mace Rothenberg,Vanderbilt-Ingram Cancer Center
John Balser,Veristat
Michael Gordon,PremiereOncology
James Gourzis,Biopharma R&DConsultant
Dan Von Hoff,TGEN
![Page 11: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/11.jpg)
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.
![Page 12: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/12.jpg)
Our medical monitors are board-certified oncologists.
![Page 13: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/13.jpg)
Our team has hands-on experience in almost every type of oncology
indication and drug type.
![Page 14: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/14.jpg)
• 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
![Page 15: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/15.jpg)
• 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
![Page 16: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/16.jpg)
We manage our resources through a single point of contact to build a strong relationship with your team.
![Page 17: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/17.jpg)
Medical
SafetyMgt
Site
DataMgt
ClinicalMonitoring
Sponsor
Project Manager
![Page 18: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/18.jpg)
We have solid relationships with key academic centers, thought-leaders and research groups.
![Page 19: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/19.jpg)
• 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.
![Page 20: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/20.jpg)
We can use sophisticated options like EDC and internet-based patient recruitment
for phase I and phase II trials.
![Page 21: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/21.jpg)
European OperationsFrance
US OperationsPhoenix, Arizona
US Clinical OperationsNashville, Tennessee
HeadquartersReno, Nevada
Data ManagementBoston, Massachusetts
![Page 22: Medelis: An Introduction to our Oncology CRO Services in the U.S., Europe and Asia](https://reader033.vdocuments.site/reader033/viewer/2022061208/548941dfb479590f0d8b5848/html5/thumbnails/22.jpg)
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