Press Releases

Averion International, Trio Clinical Research, Fulcrum Pharma and ClinResearch/ADDPLAN have been merged

merged with
September 2010

The merger was led by a group of investors including The Halifax Group, SV Life Sciences and the Comvest Group.Averion International, Trio Clinical Research, Fulcrum Pharma and ClinResearch/ADDPLAN have been merged into a new global biopharmaceutical and medical device development services organization. The merger, led by a group of investors including The Halifax Group, SV Life Sciences and the Comvest Group is part of a strategy to address the constant pressures and challenges currently facing the pharmaceutical, biotech, and medical device industry through a more unique service offering.

Patrick K. Donnelly, formerly the CEO and one of the founders of PRA International, was named Chairman and CEO of the new group. J. Matthew Bond, formerly of PRA International as well, will be joining as the Chief Financial Officer. Both are investors in the new company. “With this new financial partnership and the combination of services from each company, we can now offer clients around the world access to over 800 professionals that can provide innovative, comprehensive and proven development capabilities. The drug and device industry needs to approach development from a different and more dynamic paradigm,” Mr. Donnelly said.

Averion International
Averion International, led by Peter Gonze, Philip Lavin, Ph.D., and Gene Resnick, M.D, will be recapitalized as part of this merger and is a top 25 full-service global CRO that has conducted over 600 clinical trials during a 27 year history. Therapeutic expertise includes oncology, medical devices, and cardiovascular trials. Averion can offer services across all phases of development including feasibility, study design and conduct, consulting, medical writing, regulatory affairs, data management and biostatistics, and pharmacovigilance/drug safety. “The combined resources of our new company positions us to bring truly novel and innovative solutions to companies developing new drugs and medical devices, which sets us apart from other service providers,” commented Peter Gonze, President, Averion International Corp.

ClinResearch & ADDPLAN
ClinResearch, led by Dr. Michael Fischer and Reinhard Eisebitt, has applied adaptive clinical trial methodology and implemented tools and systems that enable seamless workflows in data management, supplies management, monitoring and statistics. ADDPLAN, headed by Mr. Eisebitt and Prof. Dr. Gernot Wassmer, has developed comprehensive, industry-standard software for the design, simulation and analysis of adaptive design trials. Together, these companies are the worldwide leaders in adaptive trial services and software. “We will be even better suited, on a global scale, to help our customers adapt to a rapidly changing clinical trial landscape, and navigate the complex process of implementing innovative trial designs,” said Mr. Eisebitt.

In addition, according to Dr. Fischer, “we are all extremely excited to be part of this new global entity focused on innovation and client service. The opportunity to share resources and expertise will dramatically improve our ability to work with clients in creative and effective ways.”

Fulcrum Pharma
Fulcrum Pharma provides the full range of global drug development and regulatory expertise essential to efficiently move development programs from research to product approval. With the continued involvement of its management team, Fulcrum will now have access to additional resources and know-how that will allow it to expand and enhance its development, regulatory and safety services. Fulcrum has locations in UK, Japan, France, Scotland and the United States.

“As part of a larger, well-funded, global organization, we.ll be able to deliver additional high-value services, to the same exacting standards that our clients have come to expect,” said Phillip Birch, General Manager, Europe.

Trio Clinical Research
Trio Clinical Research, led by Betsy Brown, bridges the gap between full-service clinical research organizations and traditional staffing companies by providing trial management, functional outsourcing and professional resourcing services. Trio provides an innovative business model that delivers flexible solutions to accommodate the individual needs of each study.

“The combined set of service offerings uniquely positions us to address the many challenges faced by our customers. Trio’s business has been built on delivering highly flexible and scalable resources. The new combination of companies allows us to continue this tradition with a much broader range of innovative and unique services.” stated Betsy Brown, President of Trio Clinical Research.

About The Halifax Group
The Halifax Group is a private equity firm that specializes in partnering with managers and entrepreneurs to recapitalize and grow lower middle-market businesses across a variety of industries including healthcare services, infrastructure services and business services. The firm maintains offices in Washington, DC; Dallas, TX; and Raleigh, NC. For more information, please visit www.thehalifaxgroup.com.

About SV Life Sciences
SV Life Sciences (“SVLS”) is a venture capital adviser and manager providing financing to businesses at all stages of development across the human life sciences sector, including biotechnology, pharmaceuticals, medical devices and instruments, and healthcare information technology and services. SVLS invests internationally with offices in Boston, MA; San Francisco, CA; and London, UK. The firm currently manages or advises six funds with capital commitments of over $2 billion. For more information, please visit www.svlsa.com.

About The Comvest Group The Comvest Group is a leading private investment firm focused on providing debt and equity solutions to lower middle-market companies with enterprise values of less than $350 million. Since 1988, Comvest has invested more than $2 billion of capital in over 200 public and private companies. Comvest is able to offer companies total financial sponsorship, critical strategic support and business development assistance. Office locations include West Palm Beach, FL; and New York, NY. For more information, please visit www.Comvest.com.

Edgemont Capital Partners, a leading healthcare investment banking firm, acted as exclusive financial advisor to Averion International.

CONTACT:

At Edgemont Capital Partners

David K. Blume, Managing Director
Phone: 212-867-8935 Fax: 212-214-0911

Jeff B. Swearingen, Managing Director
Phone: 212-867-8935 Fax: 212-937-3816

Luke J. Mitchell, Vice President
Phone: 212-867-8935 Fax: 212-214-0918