Industry Provider Profiles
ESTERN Medical, LLC

• Who We Are
• Our Services
• Our Regulatory Services
• Our US & Latin American Patient Recruitment Database
• Our Expertise
• Global Offices
• For More Information
• Contact Company

Who We Are

The ESTERN Medical CRO Corporation Group is one of the world's leading global full Clinical Research Organizations, conducting Clinical Trials across "US-North America & the Emerging Markets in the Latin America region".

We operate in two continents, in "US-North America & South America" (LATAM). Our corporate office is located in Boston & Cambridge, Massachusetts, USA and our regional LATAM subsidiary offices are spread across Mexico, Colombia, Chile and Argentina.

As an independent, privately owned corporation, since its foundation in 2002 we are passionate about being one of the preferred full service CRO partner worldwide, thus contributing to people’s health and quality of life in the Western Hemisphere and the Emerging Markets.

This leadership & professionalism is built on our internal skills and competencies, and is complemented by collaboration with external partners and clients that include Global Pharmaceutical, Biotechnology, Medical Device, CROs, and Academic - Government Institutions.

ESTERN Medical CRO applies innovative dynamic Clinical, Operational & Regulatory Development and a broad track record of therapeutic expertise to our clients. We emphasize our commitment to quality to help our sponsors and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients globally.

ESTERN Medical provides outsourced clinical trial services across all phases, through its years of experience, ESTERN Medical has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating personal interaction element of commitment to excellence.

Our Services

ESTERN Medical CRO offers a full range of clinical trial drug and medical device development services in over 22 countries across "US-North America and the Latin American Emerging Markets".

We have a successful track record of managing programs in all phases of clinical development. In "Phase I-II", we conduct studies in healthy volunteers as well as patient populations with specific medical conditions.

ESTERN Medical distinguishes itself by having clinical "Phase I" unit’s global partnerships and facilities inside hospitals to allow rapid recruitment of patients and volunteers. In "Phase II-III", ESTERN Medical has executed many pivotal trials that led to FDA & EMEA and/or international regulatory approvals.

In late "phase IV", we assist clients with the post-approval process by planning and conducting large, simple studies, registries, outcome studies, and risk management programs.

Our Regulatory Services

At ESTERN Medical CRO, our regulatory and safety guidance oversight services are a seamless part of the drug development & medical device process from beginning to end.

Our regulatory team has broad track record experience and a rapport with many US & Latin American regulatory agency divisions, that let us explore options with customers to succeed shortest route of their clinical trials and timeframe to bring their products to market.

It’s about having experience with the US & Latin American emerging markets with FDA and the European regulatory authorities, so we can explore with you the most efficient route and shortest timeframe to market. It’s therapeutic area expertise. It’s understanding regulations, such as Common Technical Document (CTD) requirements or the European Clinical Trial Directive.

We know what issues are likely to come up and can develop strategies to address them early on. In addition, our knowledge of local market requirements throughout US & Latin American countries and specific regions that gives you the advantage of submitting registration applications or clinical trials simultaneously in any regions that interests you.

We begin with a strategic regulatory, scientific, and safety planning in the clinical trial phase that you will be launching. And collaborate in the designing a study that integrates a full understanding of the current regulations and the regulatory environment from the start to completion of your study, we can help you ensure that the complete drug development process will run more smoothly and efficiently.

ESTERN Medical Regulatory Affairs team has daily-use knowledge of regional regulatory requirements across the globe. We offer competitive product development plans, rapid study startup and effective submissions strategies. This is possible through close collaboration with multi-functional project teams that support Early Clinical Trial Development, Product Registration and Late Phase trials. Our partnership with ESTERN Medical Analysis & Reporting and Safety & Risk Management groups has proven instrumental in ensuring successful development programs.

We provide full global CRO or consulting services and develop strategies for the registration of clinical trials for:

• Novel products
• Biotechnology therapeutics
• Advanced therapeutics for a broad range of products:
• New chemical entities
• Biologicals
• Medical devices

Our teams have scientific backgrounds and other significant experience from:

• Other CROs
• Regulatory Agencies
• Academia
• Pharmaceuticals and Biotechnology Industries

ESTERN Medical offers the following regulatory services covering all aspects from discovery to all phases of clinical trials development, to market approval, and leading into the post marketing studies:

• Regulatory lifecycle management
• Regulatory strategic development
• IND/ NDA/CTA submissions/maintenance
• Orphan Applications
• Agency meeting preparation
• Marketing authorization applications

Our US & Latin American Patient Recruitment Database

ESTERN Medical significantly impacts the drug development timeline by accelerating the process of recruiting and enrolling patients into clinical trials in the USA & Latin America.

ESTERN Medical attributes its recruitment success story in recruitment due to the broad variety of novel diseases and age-related chronic diseases, with patients largely unexposed to previous treatments, with a wide population of 569 million people across 21 countries in the Latin American plus an additional population of 308 million in the US North America.

By putting it all together, we deliver speedy study start-up consulting and top quality results that meet FDA & EMEA with ICH and GCP standards.

ESTERN Medical significantly impacts the Pharmaceuticals and Medical Device development timelines by accelerating the process of recruiting and enrolling patients into clinical trials across our US and Latin America Medical Centers in which we have a partnership and track record of success in diverse clinical trials phases.

ESTERN Medical has the solutions to help and guide you over our state of the art recruitment database.

ESTERN Medical offers customized single-source, full-service solutions that leverage the most cost-efficient and effective outreach, screening, and clinical site support methods for each individual trial.

We broaden the pool of high-quality, pre-screened patients. Accelerate the patient recruitment process. Increase the throughput of patients during the enrollment process.

Our Expertise

For Biotech’s & Pharmaceutical Trials

ESTERN CRO, Biotech & Pharmaceutical solutions, with our CRO management teams, provide’s an extensive experience in dealing with the specific most common issues that your Biotech & Pharmaceutical company challenges in all clinical phases I thru IV ( IND’s, NDA’s & PMA’s). We provide all the resources, skills, experience and technology you need to carry out your project from early clinical studies, proof of concept, drug product development and clinical trials straight through regulatory approval and product launch in US-North America and the Latin American Emerging Markets. And we do it all on a scale and at a cost that makes sense for you.

For Medical Device Trials

ESTERN Medical CRO guides medical device companies to bring their submission and execution (510K’s, PMA’s & IDE’s) clinical trial development to future global products approvals.

But most important efficiently and cost-effectively by providing the right clinical and regulatory strategy the first time.

Our company expertise consist of former clinical, project managers, monitors and regulatory, reviewers from top Biotech, Pharmaceutical, Medical Device and CRO global companies with a broad global knowledge and key expertise in US North America and Latin American Emerging Markets. Many of them have contributed in developing the pathways and guidelines issued in different US & LATAM Health Agencies.

Global Offices

ESTERN Medical corporate headquarters is located in Boston Massachusetts, USA.

Clinical trials and related services are conducted from offices across the USA & Latin America located in:

For More Information

For more information with your (RFI & RFP) proposal on your next or upcoming project, please do not hesitate to contact ESTERN Medical CRO at Tel. + 1 (617) 395-0204, or by E-mail at: info@estermedical.com.

If you are interested in contacting our company, please complete and submit the form below. A representative from ESTERN Medical CRO will follow up with you promptly.

If you are interested in contacting this company, please complete and submit the form below. A representative from the company will follow up with you.