Manipal AcuNova and ECRON Merge to Form ECRON AcuNova
ECRON AcuNova will provide end-to-end services for Phase I - IV clinical trials including Project Management, Clinical Data Management (CDM), Biostatistics, Medical Writing, Central Lab and Bio-Availability/Bio Equivalence (BA/BE) Studies to pharma, biotech, device and diagnostic companies. The combined strength will be 265 employees slated to grow year on year. Frankfurt will be European HQ, Princeton for US and Bangalore for Asia. Dr. Wiedey MD will continue as President, Europe and Dr Kohkan Shamsi MD PhD will lead as CEO in US. Mr. DA Prasanna, Vice Chairman and MD, will continue to lead the Company from Bangalore.
Speaking on the merger, Dr Wiedey, President, ECRON, said, "AcuNova is a company built on quality making it a primary reason for ECRON's choice in this merger. This merger will benefit our European and US clients. The possibility of extending trials from Europe to India will make drug development faster. Trial data can be analyzed with biostatisticians and data management professionals from India, speeding up submission to regulators like EMEA and US FDA. We can take up bigger complex projects with a broader range of services like central lab and PK/PD service."
On process standardization, he added, "Highest ICH GCP and FDA standards will be deployed across the organization hence clinical operations will use German practices and DM will use the Indian practice. We foresee harmonization of SOP's within the next 6 months."
On the merger, Mr. DA Prasanna, Vice Chairman and Founder, MAL, said, "Industry experience shows bringing a drug into market takes 8-10 years. Indian CRO's do not have a track record in seeing a drug through development and into market. Hence this merger will combine MAL's access to investigators and patients with ECRON's quality reputation making drugs available faster. Clients will be able to conduct trials at West and East European Hospitals and enter regulated markets."
Adding further Mr. Prasanna said, "Manipal Group supports the merger with special access to teaching hospitals and education infrastructure. We are confident that the combined strength offers a compelling alternative for clients to entrust their clinical development programs with ECRON AcuNova."
About Manipal AcuNova (www.acunovalife.com)
MAL provides Phase I - IV clinical development services including Project management, CDM, Biostatistics, Medical Writing, BA/BE and Central Lab. With research facilities in Bangalore, Mangalore and Manipal, MAL is a University backed CRO with preferred access to Manipal Medical University's 19 teaching hospitals. Manipal Medical University is Asia's largest academic medical centre treating over 1.5 mn patients with more than 1500 physicians. MAL was selected as the 'Partner of Choice' for BA/BE studies, by Frost & Sullivan for quality of services. MAL is ISO 15189 certified for clinical standards, ISO 9001 for managerial requirements and ISO 27001 for information security. The Labs in Bangalore and Manipal are CAP compliant and ISO certified. The Phase 1 facility has been audited by US FDA. The company has been awarded as India's No 1 emerging CRO by Proximare Inc. New Jersey.
About ECRON GmbH: (www.ecron.com)
ECRON, with an enviable reputation for quality, is a European expert CRO for clinical development of medicinal products for human use. Founded in 1985 by Dr. Wiedey and HQ in Frankfurt, ECRON has conducted trials for submission to European and US authorities. ECRON's studies have been audited by both US FDA and European Regulators. ECRON has direct operations in Germany, Ukraine, Poland, Spain, UK, Italy and Czech Republic and through partners in key European countries.
Posted: November 2007