Oncology Clinical Trial Expertise
Bringing an oncology therapeutic to the clinic or patient is one of the most challenging endeavors in clinical drug research and development.
ESTERN Medical has experience as a leader in oncology drug development and has guided Biotech’s, Pharmaceutical & Medical Device companies through many clinical trials hurdles across US and Latin America, in virtually every solid and hematologic oncology indication and allied indications.
ESTERN Medical has supported cancer clinical trials, through strategic and regulatory consulting, clinical development planning and full-service implementation of Phase I, II, III through IV studies, compassionate access programs and surveillance registries. Our clinicians and scientist have a broad experience with cancer trial groups.
ESTERN Medical has helped support regulatory approvals in oncology therapeutics and diagnostics, including small molecules, monoclonal antibodies, vaccines and tumor marker diagnostics.
We have provided representation at diverse Ministry of Health (MOH) authorities across US and Latin America and at other international regulatory authorities for pre-IND Phase II meetings reviews for orphan drug designations as well as NDA-Phase III trial submissions.
In Latin America we offer a wide number of advantages for executing oncology clinical trials. We have oncology key opinion leaders who were trained in the United States and / or Western Europe and return back to practice in the North / Central American or South American countries.
Our clinician research structure and medical capabilities are beyond comparable to the United States & Europe and there is good access to patient population and diseases, with a large percentage of the Latin American population residing in just two of the largest capital cities of the world Mexico City (Mexico) & Sao Paulo (Brazil) that provide us with faster trial recruitment.
In addition to our vast experience in conventional chemotherapy agents, we are increasingly involved in the exciting arena of innovative, targeted treatments for specific subgroups of patients.
We also have experience running studies of chemotherapy agent combinations, most often involving a standard treatment in addition to a trial drug.
ESTERN Medical has strong relationships with key opinion leaders, allowing us extensive access to a US and Latin American network of leading oncologists. We’ve also developed partnerships with cooperative clinical groups, hospitals and use them as an excellent source of expertise for our clinical studies.
ESTERN Medical is strategically well positioned to run many specific types of oncology studies. Our customized approach means we are able to deliver projects for smaller companies that have only a few compounds. We also are well connected to deliver large, international mega-trials.