Services

Oncology Contract Clinical Research

As a single-source provider for clinical trial planning, trial management and drug development planning, 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.

Clinical Answers, Faster

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.

What We Can Do for You

Oncology CRO Services

Medelis’ world-class medical and project teams have extensive experience in the design, performance and analysis of complex clinical trials.

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Study Design

Medelis provides clinical research study design services, leveraging thought-leadership and the hands-on expertise of our clinical team to design your oncology study.

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Study Launch

Medelis provides oncology clinical research study launch services, as part of our full-service oncology CRO offering, for phase I and phase II studies.

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Study Management

Medelis provides management for project management and clinical monitoring, medical monitoring, safety reporting, SAE narratives and document preparation.

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Medical Writing

Medelis provides medical writing services from pre-IND through NDA. Our writers’ skills and experience present study results and clear, concise and polished documents.

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Biostatistics and Data Management

Medelis provides data management and biostatistics services as an oncology CRO for phase I through phase III clinical trials in North America and Europe.

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Study Rescue

Rescue studies are often challenging for any CRO, but Medelis has been entrusted with a number of rescue studies by its clients to get them back on track.

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Drug Development Consulting

In addition to our full service oncology CRO offering, Medelis provides specialized oncology drug development consulting services in a number of different areas.

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Access to the U.S. Market

Medelis can assist a non-U.S.-based company to gain access to the US drug study market by designing the plan for the pathway through the clinic.

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Bioequivalence Design

Medelis understands the challenges with oncology bioequivalence studies, including investigator selection, laboratory procedures and documentation.

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Our Partnership Model

In addition to our permanent operations in North America and Europe, we use a partnership model that enables us to execute trials as needed in almost any country.

This flexibility allows us to access the best sites and patient populations for specific trials while eliminating costly overhead and the need to maintain a network of offices around the globe.

News & Blog

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Embracing AI in Clinical Trials: An Oncology CRO’s Insight

In our previous article, we outlined how AI may improve different areas of the oncology drug development process. The integration… [read more]

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Transforming Oncology Drug Development with Artificial Intelligence

The release of GPT 3.5 and the improvement of large language models (LLMs) has captured the imagination of many around… [read more]

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FDA’s New Guidance on Diversity in Clinical Trials: New Challenges for Patient Recruitment

The U.S. Food and Drug Administration (FDA) recently issued new guidance on the diversity of clinical trials, encouraging sponsors to… [read more]

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