ESTERN Medical is a leading global contract research organization Boutique (CRO-B) providing clinical development and post-approval services as well as business development and partnering programs in the Latin American market. We operate in two continents, in the Americas and Europe with offices in the USA, Germany, Mexico and Colombia.

Our clients and partners include Pharmaceutical, Biotechnology, Medical Devices, Academic and Government Organizations. With offices in 5 countries, ESTERN Medical applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients globally.

ESTERN Medical helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the Biotechnology, Pharmaceutical & Medical Device companies and healthcare industries across Latin America. ESTERN Medical is headquartered near Boston in Cambridge, Massachusetts; ESTERN Medical has offices in two continents and four countries, USA, Germany, Mexico and Colombia.

ESTERN Medical operates through two major groups:

ESTERN Medical Clinical Development Services provides all clinical trials research aimed at regulatory approval, post-launch research, business science, product safety and value.

Our Global Clinical Development Services encompass all Phases I, II, III & IV trial services, such as clinical trial management & medical and regulatory affairs, biostatistics, patient recruitment, ECG services, drug safety and strategic research. Global Central Partnership Labs to support all phases of our clinical trials. ESTERN Medical Global Business Science on product development; reimbursement and pricing; health outcomes; regulatory compliance (e.g., FDA / EMEA, LA enforcement, quality systems); and due diligence for biotech, pharmaceuticals and medical device companies in Latin America Medical Education involving the development and delivery of continuing medical education programs for health care practitioners.

ESTERN Medical Business Science Commercialization, responsible for sales force and medical communication services. Our sales solutions include recruitment, training and deployment for our customer. ESTERN Medical - managed primary and secondary sales teams, health management services and vacancy management. We provide medical communications to promote physician education and communications programs, including symposia, exhibition support at major scientific congresses, advisory boards and publication planning.

Our Clinical Research Services

ESTERN Medical provides global clinical research services to the Biotechnology, Pharmaceutical and Medical Device industries across Latin America.

Clinical Research Development & Regulatory Services

Better than any other Contract Research Organization development resource, ESTERN Medical faces and answers over Clinical R&D and Regulatory risks with our broad knowledge solutions.

These solutions are delivered by a highly responsive team of professionals building a customized package of services based on your needs with our broad expertise and knowledge in Latin America. ESTERN Medical serves in the local Latin American markets such as Mexico, Colombia, Venezuela, Brazil, Ecuador, Peru, Chile, and Argentina.

From early clinical development and regulatory through late-phase clinical trials, ESTERN Medical offers the entire range of integrated product development services you need. No matter where your point of entry is into our resources, ESTERN Medical will craft a customized clinical and regulatory program providing seamless access to our full range of development services to meet your specific needs in Latin America.

With ESTERN Medical, you can minimize your risk, optimize development, and give your team every possible advantage in accessing new insights and solutions. You can off-load tasks while uploading knowledge assets and expertise.

At ESTERN Medical it's all about Results and Excellence

Our Expertise Phases I, II, III & IV in Latin America

ESTERN Medical is your development Contract Research Organization partner through these critical phases.

ESTERN Medical helps you develop strategies to:

• Speed up development.
• Recruit the right patients more quickly into our key medical centers partnership and strategic database for best results in your clinical trial success. Strategically control costs.
• Ensure regulatory compliance many Latin American countries.
• Anticipate and remove roadblocks across each country.

Your ESTERN Medical team provides:

• Superior Project Management

With a commitment to quality, our professional consulting team ensures that your needs are met. You have a consistent, dependable point of contact that gives you access to the entire range of ESTERN Medical capabilities. Your team ensures that the right tools are used in order to move you efficiently through Phases I, II, III and IV and beyond.

• Tools for Improving Study Start-Up

With a powerful mix of patient recruitment and site management tools, ESTERN Medical vastly improves one of the most time-sensitive stages of any Phase I, II, III and IV studies.


Phase I

ESTERN Medical Phase I services brings together an unequalled breadth and depth of experience and services. We offer unrivaled expertise for safe, innovative, early-phase human drug development to Good Clinical Practice and Good Laboratory Practice standards.

All ESTERN Medical Phase I units combine superb healthcare and analytical facilities with the complex amenities needed to attract, house and motivate volunteers.

The specialized staff at each site includes physicians, pharmaceutical scientists, nurses, investigators, analysts and pharmacokineticists with experience in numerous therapeutic areas.

Each unit has established its own reputation for excellence and its own loyal client base.

ESTERN Medical is an expert in the conduct of complex, procedurally intensive Phase I studies, ESTERN Medical provides customized services to advance your product to the next development phase. Our capacity to accommodate large trials combined with our dedicated, experienced staff deliver effective integrated planning and implementation for Phase I trials in Latin America.


Phase II & III Clinical Trials:

Our comprehensive Phase II-III experience, support systems and global infrastructure provide the highest level of professional program management and services to advance your product through development and approval.

If the blockbuster potential pharmaceutical drug is there, no one can bring it out as effectively as ESTERN Medical; Phase II and III trials are at the heart of our business, and form the focus of the most valuable services we offer customers. That’s because we can bring in the heavy hitters across the board – in every medical, business and technological specialty required to manage every detail of a complex and fast-moving project.


Phase IV

Our strength in late stage drug development derives from strategically aligning clinical research and marketing objectives. ESTERN Medical’s post-approval group explores and implements a wide range of strategies to capitalize on the strengths of your product and maximize its life cycle.

Safety continues to be a key issue for both physicians and patients. More than ever before, scientists, researchers and Biotech, Pharmaceutical & Medical Device companies like yours recognize that expanding safety initiatives is not simply an option, but a necessity. Your continued success is dependent upon developing therapies that have a strong track record when it comes to patient safety.

ESTERN Medical understands your commitment to patient safety and offers our Safety Solution Center. We will work with you to expand safety initiatives and will help you anticipate, and prepare for critical issues that may arise in your development.


The Guiding Principles in the Regulatory Affairs Steps for Latin America.

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

Our regulatory have broad track record experience and a rapport with many 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 Latin American, 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 Latin American countries and specific regions in Latin America gives you the advantage of submitting registration applications simultaneously in any regions that interest 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 also provides Business Science coordination and of clinical and post-marketing studies throughout Latin America.


IRB’s Independent Institutional Review Board in Latin America

ESTERN Medical provides you with guidance over independent ethical review of your drug and/or device trials when review of protocols for the protection of human research subjects by an on-site board is not available across Latin America.

Independent IRB across Latin America has provided this service to a growing national clientele of investigators and sponsors.

ESTERN Medical IRB guidance provides independent ethical review of your drug and/or device trials when review of protocols for the protection of human research.

The Independent IRB operates in compliance with federal regulations governing Institutional Review Boards set forth in 21 CFR Part 56, federal regulations governing informed consent set forth in 21 CFR Part 50, as well as ICH guidelines for good clinical practices. The Independent IRB can review studies for a single investigator or serve as a central IRB for multi-center trials across Latin America.


Confidentiality

The confidentiality of information contained in the documents submitted to the Independent IRB is carefully preserved. Protocols, investigator drug brochures, informed consent documents, IND’s, NDA’s, PMA’s IDE’s 510K’s safety reports, and other records are safeguarded in locked files, with access strictly limited to the IRB staff. In addition, each Board member signs an agreement to treat all reviewed material as confidential.

The overriding objective is to ensure that the privacy of individuals, industries and institutions involved in the protocol is respected.


Meeting Schedule

The IRB meetings are usually twice a month during the year. Specific meeting dates can be provided upon request. In addition to the schedule above, ad hoc sessions are convened to meet a client's special needs.


Turn-Around Time

The protocol, IDB, informed consent, and any proposed advertising should be submitted to the IRB no later than one week before the next scheduled IRB meeting. After review by the board, the investigator and/or sponsor will be notified of the outcome within 24 hours. Expedited reviews are handled within 24-48 hours.


Quick IRB Review

The IRB meets twice a month or special meetings can be arranged. Approval letter for full-board review items are sent approximately 48-72 hours after the IRB meeting, and expedited review items are sent approximately 24-48 hours from their submission.


Latin America Patient Recruitment

Latin America Clinical Trials Recruitment

ESTERN Medical significantly impacts the drug development timeline by accelerating the process of recruiting and enrolling patients into clinical trials in 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 and a wide population: 552,296,094 people across 20 countries Latin America.

Therefore one of our main objectives is to keep trials on schedule - or even ahead of schedule.

ESTERN Medical is increasingly leveraging its reach and knowledge in Latin America. More and more customers are discovering the advantages of conducting trials in the diverse non-traditional regions of the world, where patient populations, well-trained investigators and high-quality communications systems are readily available - and where ESTERN Medical has years of experience and expertise mastering local disease profiles, customs and regulations. By putting it all together, we deliver speedy study start-up consulting and top quality results that meet FDA and ICH GCP standards.

Expanded reach, easier access to specific diverse patient populations in Latin America Different therapeutic indications tend to cluster in different regions of the world. ESTERN Medical consulting and teams work in non-traditional regions and include physician specialists in key therapeutic areas to help fine-tune study designs and protocols.

Patients in non-traditional regions such as Latin America have a high rate of protocol compliance and low dropout rates because of the high standards of medical care available through clinical trials.

This and the combination of our reach and local knowledge in Latin America can result in speedy recruitment of specific patient populations.


ESTERN Medical Patient Recruitment Data Base in Latin America Patients Recruitment

ESTERN Medical significantly impacts the drug development timeline by accelerating the process of recruiting and enrolling patients into clinical trials across our 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 database provides Biotech, Pharmaceutical and Medical Device Companies patient enrollment solutions for clinical trials.

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.

Broaden the pool of high-quality, pre-screened patients.

Accelerate the patient recruitment process.

Increase the throughput of patients during the enrollment process.


Our Patient Recruitment Solutions for Sponsors

The primary reasons clinical trials fall behind are:

Patients are unaware of study opportunities.

It is difficult to motivate patients to switch from an already-existing therapy.

Competing protocols mean there are only a limited number of patients available to participate in studies.

There is poor planning regarding study start-up.

By accessing ESTERN Medical data base expertise and combining services on recruitment and informatics data, sponsors can ensure success.


Patient Recruitment

ESTERN Medical employs the print and broadcast media to reach a diverse population.

ESTERN Medical produces the recruitment messages and manages media planning, placement, and monitoring for TV and radio for clinical trials in Latin America.

Sponsors can provide a dramatic reduction in recruitment timelines by combining our broadcast-based recruitment with our call center services.


Patient Recruitment Solutions for Investigators

ESTERN Medical recognizes the importance of the clinical investigator in the patient recruitment process. We offer customized consulting services to help investigators streamline the patient recruitment, screening, and enrollment process.

Biotech & Pharmaceutical

How to Gain Access to All the Resources from ESTERN Medical.

ESTERN Medical Biotech & Pharmaceutical solutions, with our CRO Boutique team, have extensive experience dealing with the specific challenges that your Biotech & Pharmaceutical Company challenges. We provide all the resources, skills, experience and technology you need to carry your project from early clinical studies, proof of concept, drug product development and clinical trials straight through regulatory approval and product launch in Latin America. And we do it all on a scale and at a cost that makes sense for you.

ESTERN Medical can help you figure out what you should and what shouldn't do. What tests are essential?, How long will they take?, How do you get started, and what do you do next?.

ESTERN Medical has done it all, for companies as small Biotech and big Pharma both locally and globally.

In addition, ESTERN Medical has developed a range of exciting options for smaller companies that give you access to the full range of ESTERN Medical CRO Boutique services while cutting your up-front and out-of-pocket costs.

Our Clinical Development group creates these special opportunities through sophisticated risk- and reward-sharing strategies.

At ESTERN Medical it's all about Results and Excellence.


Medical Devices

ESTERN Medical helps the medical device global companies to bring Clinical Trials to products to be market in the United States, Europe, Latin America and the world and most important efficiently and cost-effectively by providing the right clinical and regulatory strategy the first time.

In a world of challenging and dynamic regulations issues, it is essential to maintain your business with new product introductions.

This necesitates a robust system for handling clinical trials and regulatory issues as well as detailed knowledge of particular requirements. ESTERN Medical CRO Boutique assists you in route you in to the proper Latin America success.

Our experts consist of former clinical, regulatory, reviewers from top Biotech, Pharmaceutical, Medical Device and CRO’s global companies with broad global knowledge and key expertise in Latin America. Many of them have contributed in developing the pathways and guidelines issued in different Latin America Health Agencies.

We help you plan your clinical development.

We provide advice and support for preparation of 510k, IDE, PMA submissions.


Business Development Science

ESTERN Medical Smarter Solutions for Commercial Success.

ESTERN Medical is the world’s leading contract sales organization in Latin America, providing our pharmaceutical, biotechnology and medical device customers with innovative sales solutions, high quality sales teams, and the flexibility that is required in today’s unpredictable marketplace.

ESTERN Medical developed the concept of contract pharmaceutical sales teams in the Latin America. Since then we have recruited, trained and managed more sales representatives, front-line managers, nurse advisors and clinical educators than any other contract sales organization.

A result of this experience is a number of benefits in working with us: ESTERN Medical provides innovative sales solutions that complement your capabilities and helps maximize market share of your brands in the marketplace.

ESTERN Medical is committed to understanding each individual customer’s challenges before applying our deep industry experience and expertise to develop flexible, quality sales solutions.

ESTERN Medical can mobilize the right people, skills and technologies at the right time to provide you with the flexibility you need to maximize the success of your brands.

Our global & Latin America presence brings a depth and breadth to our specific local market expertise; and the unique skills required in successfully fielding multi-country projects.

Our experience spans virtually every therapeutic area, every type of product and every key pharmaceutical market in Latin America.

ESTERN Medical corporate headquarters are located in Cambridge, MA, USA.

Clinical trials and related services are conducted from offices located in:

• North America
• Cambridge, MA, USA
• Tel: [+1] (617) 395-0204

• San Diego, California, USA
• Tel: [+1] (858) 427-5281

• Europe
• Munich, Germany
• Tel: [+49]-89-389-000-67

• Latin America / South America
• Mexico City, Mexico
• Tel: [+52] (55) 5350-0699

• Tijuana, Mexico
• Tel: [+52] (55) 5350-0699

• Bogota, Colombia
• Tel: [+57] (312) 584-6324

Contact Information

ESTERN Medical de México S.A. de C.V.

Avenida de las Torres 202 C-110
Col. Misiones de Tlalpan II, Mex-DF
C.P. 14370.
USA, Germany, Colombia, Chile Mexico, Mexico City
Phone: [+52] (55) 5350-0699
E-mail:

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