Headquartered in France, Medelis Europe is an oncology contract research organisation that manages European preclinical, phase I, phase II and phase III clinical trials for European, Asian and U.S. sponsors.
As a worldwide oncology CRO, Medelis is helping biotechnology and pharmaceutical companies by delivering the best total solution—and all the support required—to optimize the return on your clinical research investments. And we accomplish that in the quickest, most responsive way possible.
Our approach is driven by a critical mass of clinical research expertise, the ability to identify and focus on the most significant challenges, and your need for prompt results. Our world-class insight and experience in the development and execution of clinical research plans and protocols delivers the decision support you need to chart your next clinical move.
Expertise in European trials
Medelis Europe delivers complete oncology CRO services from preclinical through phase III. European, U.S., and Asian sponsors looking to bring drugs to the U.S. & European markets can take advantage of Medelis’ full service offering, which includes EDC for phase I studies, internet-based patient recruitment, and integrated preclinical studies aligning the preclinical, regulatory and clinical teams.
Based in France, Medelis Europe provides contract research services to European, Asian & US sponsors running clinical trials in Europe
Medelis' services include:
- Oncology clinical trial management and design, including regulatory approval plans from Phase I through marketing approvals
- Preclinical program design, management and execution
- Preclinical review and "gap analysis"
- Protocol development
- Site identification, qualification, management, contracting and payment
- Investigator identification and recruitment
- Project management and monitoring of clinical studies
- Medical monitoring and management
- Oncology patient recruitment and accrual
- Data management
- Biostatistics analysis and reporting
- Document preparation and production
- Quality assurance and regulatory compliance
- Medical writing
Oncology Expertise
From our advisory board to our project managers and our CRAs, Medelis offers deep experience in every facet of the oncology drug development process at all levels of our organization. Our clinical team members and medical personnel have critical first-hand experience in the complex issues often associated with oncology studies, which means that highly experienced resources will be working on your trial. And whether it’s a standard dose-escalation phase I trial or a complex rescue of a phase III trial, chances are that our team has handled it before.
Medelis' expertise begins with the thought leadership of our world-class Medical Expert Team, a group that delivers a wealth of experience in the design, performance and analysis of oncology clinical trials. These experts are actively involved with our study team, providing immeasurable expertise with study design, site selection, patient populations, and the latest trends and ideas in oncology drug development from around the world.
» Learn more about our oncology expertise
Led by Managing Director Deirdre Tessman, Ph.D.
Formerly of Tessman Technology Ltd. and ILEX Pharmaceuticals, Dr. Tessman brings more than 30 years of worldwide drug development and regulatory experience to the Medelis organization. She has directed all phases of pharmaceutical development from research through drug approval and marketing with additional expertise in the startup and turnaround of pharmaceutical companies.
From 1997-2001, Dr. Tessman provided contract research services to clients in Europe and the U.S. as the Managing Director/Senior Vice President, European Operations for ILEX Services Limited. In 2001, she acquired the CRO business from ILEX and transformed it into Tessman Technology, a successful privately-held oncology CRO and clinical investigator network offering clinical monitoring services in both the U.S. and the European community.
Prior to her success in the CRO industry, Dr. Tessman served as the Vice President, Drug Development for ILEX Pharmaceuticals. In that role, she established and led a drug development infrastructure of 130+ employees including regulatory, clinical research, medical writing, project management, biostatistics, data management and business support personnel. She led drug development of ILEX-sponsored and contract-based projects and served as the company’s primary liaison with NCI, opinion leaders, investigators, CROs and pharmaceutical company collaborators.
Dr. Tessman previously served as Director, Worldwide Pharmaceutical Projects for Schering AG, where she led the company’s first global project management team in obtaining EMEA approval of a small molecule oncology drug. She has also served as the Director, Pharmaceutical Projects for Triton Biosciences and spent 20 years with Warner-Lambert/Parke-Davis, where she directed cardiovascular clinical development.
Learn more about Medelis Europe
To begin a discussion, we invite you to contact Deirdre Tessman today.
