Embarking on the journey of bringing an oncology therapeutic to the clinic or patient represents one of the most formidable challenges in the realm of clinical drug research and development.
As a vanguard in oncology drug development, ESTERN Medical has garnered substantial experience, providing steadfast guidance to Biotech, Pharmaceutical, and Medical Device companies through the intricacies of numerous clinical trials across the United States and Latin America. This spans nearly every solid and hematologic oncology indication, as well as allied indications.
ESTERN Medical’s commitment to cancer clinical trials manifests through strategic and regulatory consulting, comprehensive clinical development planning, and the adept execution of Phase I, II, III through IV studies. Our capabilities extend to compassionate access programs and surveillance registries, with our clinicians and scientists boasting broad experience in collaborating with cancer trial groups.
In the landscape of oncology therapeutics and diagnostics, including small molecules, monoclonal antibodies, vaccines, and tumor marker diagnostics, ESTERN Medical has played a pivotal role in supporting regulatory approvals.
Our representation at various Ministry of Health (MOH) authorities across the United States and Latin America, coupled with engagement with international regulatory bodies, underscores our commitment to navigating pre-IND Phase II meetings, reviews for orphan drug designations, and NDA-Phase III trial submissions.
In Latin America, we present a myriad of advantages for executing oncology clinical trials. Leveraging oncology key opinion leaders trained in the United States and/or Western Europe, who subsequently return to practice in North/Central American or South American countries, we benefit from a robust clinician research structure and medical capabilities comparable to those in the United States and Europe. This, coupled with expedited trial recruitment fueled by a concentrated population residing in major capitals such as Mexico City (Mexico), Bogota (Colombia), Santiago (Chile), Buenos Aires (Argentina), and Sao Paulo (Brazil), positions us for success.
Beyond our extensive experience with conventional chemotherapy agents, we actively engage in the dynamic arena of innovative, targeted treatments tailored for specific patient subgroups.
Our proficiency extends to overseeing studies involving chemotherapy agent combinations, often integrating a standard treatment alongside an investigational drug.
ESTERN Medical’s robust relationships with key opinion leaders (Kols) grant us unparalleled access to a network of leading oncologists in the United States and Latin America. Collaborations with cooperative clinical groups and hospitals further enrich our studies with expert insights.
Strategically positioned, ESTERN Medical excels in running diverse oncology studies, catering to smaller or mid companies with limited compounds, and seamlessly scaling to manage large, international mega-trials. Our customized approach ensures project delivery is aligned with the unique needs of each endeavor, solidifying our position as a trusted partner in advancing oncology clinical research.
