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.
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.
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.
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.
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.
Relationships are important to us. Reach out to learn more about how our approach, experience, investigator relationships, bid transparency and flexibility deliver success for our clients.