Oncology Drug Development Consulting for New Studies or Getting a Current Study Back on Track

In addition to our full service oncology CRO offering, Medelis provides specialized, strategic consulting in a number of different areas. Leverage our expertise to supplement your team, or to get to know us before selecting us to manage your entire study.

Troubled Study Analysis and Recommendations

Oncology studies are complex. If your study is off track, Medelis’ oncology clinical research management team and members of our Medical Advisory Board can review and assess all of your study elements. We’ll identify the key issues preventing your study from meeting your timelines, and develop a study rescue plan focused on resolving current bottlenecks and study challenges. Learn more >>>

Adaptive Design Alternatives

Adaptive trial designs are a hot topic in oncology drug development, especially in phase I and phase II studies. Medelis can analyze your drug and create a design outline for an adaptive trial for your phase I or phase II study. This short-term consulting engagement can have a dramatic impact on your clinical development path – delivering faster data to reduce your time to market. Learn more >>>

Regulatory Approval Consulting

A key element to successfully bringing your drug to market is an understanding of how to navigate the regulatory agencies in the U.S. and Europe. The Medelis team can provide flexible services ranging from answering specific regulatory questions, to writing, compiling and filing regulatory submissions, to setting up and leading regulatory meetings on your behalf. Learn more >>>

Access to the US Drug Study Market

For sponsors with little to no U.S. presence, designing and managing clinical trials for oncology drugs in the U.S. is an arduous task. Medelis will design the plan for bringing a non-U.S.-based company’s drug into the clinic, giving you the assurance of a team of oncology experts, who have a comprehensive understanding of the nuances of the U.S. market, to guide your drug development plan. Learn more >>>

Bioequivalence Study Design for Generic Oncology Drugs

Designing and managing a bioequivalence (BE) study in cancer patients presents a unique set of challenges. Medelis can design your plan to overcome the typical challenges of managing an oncology BE study, including investigator selection, the investigator/patient relationship, documentation and laboratory procedures, and coordinating vendor activities. Learn more >>>

Assistance in Refining Study or Protocol Design

The right protocol and clinical study design can make the difference between spending years in the clinic obtaining nebulous data, and getting the answers you need on an efficient timeline.  The Medelis Medical Advisory Board and oncology clinical operations team can assist with your protocol design, and handle all the details of the protocol writing. Learn more >>>