A Specialty Oncology CRO

Medelis is a full-service oncology CRO led by a highly-skilled clinical team and oncology drug development thought-leaders.
Oncology Expertise for Your Study

Pioneering immunotherapy treatments

Medelis has been developing immuno-oncology therapies since 2008. We work directly with sponsors on the development of clinical strategy (protocol, endpoints, regulatory) and with study execution in this growing field.
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Deep operational oncology experience

Medelis delivers decades of oncology clinical experience for your study. We are not a training ground for people just starting in oncology research. All of our operational resources are highly experienced and have proven experience in oncology studies.
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Access to the right patients

Our extensive investigator relationships enable us to get your study launched quickly. Proper site selection is critical to the success of any oncology study. It’s even more critical in the rapidly expanding area of cancer immunotherapy.
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An extension of your team

If you’re tired of the big CROs, we’re a partner by your side. Relationships are our #1 priority. It’s about making the right decisions, supporting your needs, and providing streamlined trial planning and management to get you the results you need.
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The Value of a Specialty Oncology CRO

You need the right data, as early as possible, to optimize the results of your oncology drug development efforts. As a specialty oncology CRO, Medelis has the breadth of capabilities, depth of expertise, focus and agility to deliver accurate results – quickly.

For our clients, this means more than completing your trial on time and on budget; it also provides the decision support to determine your next clinical move.

  • Deep oncology expertise at every level of your trial
  • A flexible, collaborative approach to integrate with your team
  • World-class drug development expertise
  • Transparent bidding for cost savings and cost certainty

The Medelis Difference

Expert Oncology Guidance

Quantified Oncology Expertise

Dedicated Project Manager

Rapid Start Up

Flexible Resourcing

Cost Certainty & No Change Orders

Experience in pharmaceuticals, devices and pharmaceutical/device combinations.
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20+
experience in oncology indications
3
continents covered
150+
projects

Our Services

Oncology CRO Services
With our full-service offering, we can create and implement a detailed drug development plan to address all regulatory needs and requirements.

Flexible Resourcing
Augment your team with our flexible resources, with unit-based costing, monthly billing, transparent costing and change orders only at your request.

Rescue Studies
Rescue studies are often challenging for any CRO, but Medelis has been entrusted with a number of rescue studies by its clients.

Drug Development Consulting
Medelis provides specialized, strategic consulting in a number of different areas. Leverage our expertise to supplement your team.

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

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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Rapid Phase I Study Start-up and Conduct

A European client contracted with Medelis to conduct a phase I first-in-human study with an immunotherapy treatment in the US.  The client had no operations in the US and lacked understanding of the clinical and regulatory environment for phase I oncology studies in the US.

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Accelerated Completion of Cancer Vaccine Trial

A US client contracted Medelis to conduct a complex phase II trial using an engineered bacterium in a combination therapy in patients with pancreatic adenocarcinoma. The client had some enrollment challenges with their phase I study conducted by another CRO and looked for better success with their phase II study.

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Phase III Rescue of Global Trial

An existing client requested Medelis to take over a phase III global study.  Significant backlog of data existed at the sites, the quality of monitoring was poor, regulatory documentation and Trial Master File were in disarray and patient enrollment had significantly dropped due to upset investigators.

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Oncology Expert Review of Clinical Data

A top 5 pharmaceutical company had a severe bottleneck with the internal clinical review of patient profiles, statistical output, endpoint assessments, protocol deviations, and SAE reconciliation.  Development timelines for their critical, high-profile agent were being negatively impacted.  The client’s clinical operations team was unable to identify and staff appropriate team members with the skills and oncology experience required to successfully eliminate the backlog and keep up with the high-volume of patient data.

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Careers

Medelis is a specialty oncology CRO with a range of career opportunities. We provide a stimulating and enjoyable work environment—and the opportunity to contribute to some of tomorrow’s most exciting medical breakthroughs. If you have a strong background in oncology, we’d like to hear from you.
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