News

Boston, MA & San Ramon, CA – February 7, 2012

ESTERN Medical, a full-service contract research organization (CRO), and Nextrials, Inc., a leader in clinical research software and services, today announced a partnership that will significantly improve sponsor access to clinical trial data and provide better cost control. ESTERN sponsors electing to utilize Nextrials’ Prism®, an electronic data capture (EDC) and clinical trial management platform, will now be able to take advantage of real-time access to investigator site data and Prism’s easy-to-use tools that provide faster study starts, better adverse reporting and simplified integration with electronic health records (EHR).

As a lead innovator in the EDC industry, Nextrials is at the forefront of developing and improving the next generation of eclinical technology: the integration of EHR data with EDC utilizing the Retrieve Form for Data capture standard (RFD). Nextrials is the only company listed as a CDISC Registered Solutions Provider for EHR integration.

"As CROs and sponsors compete for clinical sites and trials become more costly and complex, technology tools such as Prism have never been more valuable,” said Jorge Estrella MD, founder, president and chief medical officer, ESTERN Medical CRO. "Prism gives sponsors the ability to better manage and predict investigator site EDC data, logistics, management and costs, and can solve critical business challenges throughout the clinical research process."

Nextrials’ award-winning Prism melds sophisticated clinical trial management functionality with EDC in a single, integrated package. By receiving a constant flow of data, Prism enables sponsors and sites to fully utilize real-time integration of disparate information and data sources, such as a hospital’s EHR or patient records, to better provide a continuum of care for patients enrolled in clinical trials. This accelerates the time to market for new drugs and devices, improving trial safety and monitoring and substantially lowering development costs.

Prism has been globally deployed in North and South America, Europe, Asia, Africa and Australia.

“Nextrials and ESTERN are well-matched to assist even the smallest of research and development teams,” said James Rogers, co-founder and CEO, Nextrials. “Since Prism can be implemented quickly and without the need for in-house IT staff, ESTERN sponsors regardless of size can take advantage of better data access and lower management costs. This partnership will also help Nextrials expand its service experience in emerging Latin American markets.”

About ESTERN Medical

Founded in 2002 by research physicians and clinicians, ESTERN Medical CRO Corporation Group is one of the world's leading global full clinical research organizations. It conducts all phases of clinical trial development for global pharmaceutical, biotechnology, medical device and academic/government institutions and companies across North America and Latin/South America. Headquartered in Boston, MA, ESTERN has operating offices on two continents and regional subsidiaries spread across Mexico, Colombia, Chile, Brazil and Argentina. For more information, visit www.esternmedical.com or call 617-395-0204.

About Nextrials

Founded by pharmaceutical researchers in 1999, Nextrials offers today’s most novel products and services for speeding the delivery of life-saving drugs and medical devices to market. Prism®, its award-winning Electronic Data Capture (EDC) solution, has been used at over 1,500 research sites to streamline the initiation and management of clinical trials. Nextrials has achieved the status of Registered Solutions Provider with the Clinical Data Interchange Standards Consortium (CDISC). The company is headquartered in the San Francisco Bay area. For more information, visit www.nextrials.com or call 925-355-3000.

As medium-sized and large CROs continue their quest to get bigger and get acquired, smaller CROs are on the march around the globe, expanding as best they can to attract contracts from smaller pharmaceutical companies and biotechs seeking something approximating worldwide reach.

Estern Medical CRO, based in Boston but previously focused only on trials in Latin America, is about to go on a hiring spree in order to begin conducting trials in the United States. And Munich, Germany-based Harrison Clinical Research (HCR) has, through a recent acquisition, established a presence in Edmonton, Alberta, Canada; Mexico City, Mexico; and Buenos Aires, Argentina.

Said Jorge Estrella, M.D., Estern’s president and chief medical officer, establishing full-service operations in the U.S., particularly in Boston, will put the CRO in a much better position to handle trials on both continents as clients request them. All of the privately held CRO’s 50 employees are in Latin America, but by year’s end, Estern’s two Boston-area offices will have about 30 additional employees, Estrella said, including regulatory staff, monitors, biostatisticians and medical writers.

This move is in response to clients saying they can’t conduct all of their trials in emerging markets, but must do a portion of them in the U.S., said Estrella.

Estern, launched in 2002, has offices in Mexico City, Mexico; Bogota, Colombia; Santiago, Chile; and Buenos Aires, Argentina, in addition to Cambridge and Boston. The CRO has focused in the therapeutic areas of oncology, cardiology and diagnostic imaging.

Harrison Clinical, in its effort to offer global coverage for less, recently acquired CRO Global IQ, which conducts phase II-IV work in Canada, Mexico and Argentina.

“The addition of Global IQ will be totally complementary, as we have no operational activity in any of these countries,” said Francisco Harrison, M.D., founder and head of HCR, which has been in business for 24 years. The CRO has 12 offices across Europe, one in Russia, one in Israel and one in the U.S. HCR inherited its Princeton, N.J., office three years ago as part of an acquisition.

Harrison said HCR and Global IQ had collaborated on trials over the last two years. He’s especially excited about being able to expand into Latin America. In addition, Global IQ is a member of Research Point Global, a partnership of small CROs that work together to try to offer a global reach.

Harrison said the acquisition should bring HCR’s annual revenue to around $50 million.

The acquisition is HCR’s sixth; all have been funded with the company’s own capital. Harrison said it will enable the 480-employee company to add 58 employees, and he plans to hire 34 more as soon as possible. Employees being sought include CRAs and project managers in Germany, France and Latin America.

HCR focuses on the therapeutic areas of oncology, transplantation and central nervous system (CNS). Global IQ’s areas of focus include oncology and CNS. The company also brings to the table its proprietary data capture system.

Global IQ’s president and CRO Paul Braconnier will stay on to head up Latin American operations for HCR, said Harrison.

HCR serves the medium-sized and small pharma and biotech sector of the industry and also conducts many phase I and phase II proof-of-concept trials for big pharma and big CROs in oncology. Rescue trials, said Harrison, account for about 10% of the CRO’s business.

Are more such buys afoot for HCR? Not immediately, said Harrison. But when it is time, he wants to look within the U.S. “At the moment we just want to take time to consolidate and absorb this one,” he said, “but later we’ll be looking to grow more in the U.S., probably through acquisitions.”

As for Estern’s future plans, Estrella says the CRO is looking to expand into the U.K. and possibly Germany within two years.

Suz Redfearn

CenterWatch News Online: http://www.centerwatch.com/news-online/article/2137/as-big-cros-keep-getting-bigger-smaller-cros-estern-harrison-are-expanding-globally

ESTERN Medical CRO, one of the top independent USA & Latin American privately owned Clinical Research Organization (CRO) and Consulting Company announced today it has accelerated its USA expansion as part of its continued investment in US-North America, ESTERN Medical CRO, a global full-service Clinical Research Organization (CRO) and (CSO), will inaugurated its full operation services in August, 2011.

ESTERN Medical is strategically located in the US-East Coast in the New England, Boston & Cambridge area in one of the top most important global Biotech, Pharmaceutical & Medical Device research corridors named “Genetown”.

The ESTERN Boston offices will focus on clinical trials research & development, medical writing, pharmacovigilance, safety, biostatistical, monitoring, regulatory, product registrations, project management, business development and other knowledge CRO processing-related services.

ESTERN Medical CRO, President & Chief Medical Officer, Dr. Jorge Estrella MD., said: “The office in Boston on the US-East Coast, will fully compliment the services we offered in the Latin American regional offices for the provision of US-North American clinical trials and regulatory services for the US North American and European companies wanting to execute trials and register their products in the USA & Latin America”.

The USA operations make it uniquely positioned to offer trials across the two continents North America & Latin America , providing the benefits of South America highly regarded cost-effective clinical trial capabilities, and at the same time take advantage of access to the much larger US market for rapid patient enrollment -a service that has to date only been available via large global CROs at higher overhead costs.

ESTERN Medical CRO is the ideal partner for USA and European companies Biotech’s, Pharmaceutical, Medical Device & CRO companies expanding their clinical development program offshore, and requiring clinical trials and regulatory affairs services of a CRO in the all important USA market,” said Mr. Robert Morgan J.D., M.S., & B.S. Head Scientific Regulatory Legal Affairs & Quality for ESTERN Medical.

The company, which now employs staff in USA, Mexico, Colombia, Chile and Argentina, has recently been recognized for its clinical research capabilities and strong alliances and partnerships.

ESTERN Medical CRO has came out on top against its competitors over key criteria including “research capabilities, breadth and depth of services, with a geographical international coverage in the emerging markets with a strategic alliances & partnerships that would enhance capabilities and the growth strategies adopted in pursuit of corporate objectives”, said Claudia Hernandez, B.S. & RPT., Director Clinical Operations for ESTERN Medical.

ESTERN Medical CRO Group, Dr. Jorge Estrella MD., ESTERN Medical CRO President & Chief Medical Officer, commented that ESTERN conveys our warmest congratulations to  our Head Corporate Advisory Board, Michael Webb as the new appointed President & CEO at Allegro Diagnostics Inc in Boston, Massachusetts.

Allegro is a molecular diagnostics company, focused on the development and future sale of innovative genomic tests for the diagnosis, staging and guided treatment of lung cancer and lung diseases. By no doubt Mike will do an extraordinary job in guiding the direction of the company pipeline, Dr. Estrella comment.

Boston, MA., ESTERN Medical CRO and Spanish Salutis International CRO., have announced a new business collaboration, aimed towards expanding expertise in the clinical research trials in both geographic regions in Latin America and Europe.

Salutis International S.L., is a privately owned, full-service CRO with headquarters in Barcelona, Spain, with offices in Madrid and Coimbra (Portugal).

With this alliance both companies will offer customised, flexible solutions for complex clinical studies. Both, ESTERN & Salutis, are committed in meeting the clients' needs not only in the Latin-Iberican-Portugues populations both beyond such borders and regions.

Our global sponsors are more at ease with a CRO that have multi regional presence and offer end to end services. We are able to address this need, with the support of Salutis a highly reputed CRO in the Iberian Peninsula of Europe.

ESTERN Medical CRO & Salutis International CRO look forward in working together in two of the top competitive markets. Dr. Jorge Estrella MD., ESTERN Medical, President & Chief Medical Officer & Dr. Oriol Ros MD., MBA., Salutis International Business Development Director commented that this will a beneficial business relationship for both of our companies to provided this new portfolio to the clinical trials research industry.