Two leading CRO´s, Manipal AcuNova Ltd (MAL), India and ECRON
GmbH, Europe today announced a definitive agreement to merge. This new
entity ECRON AcuNova will combine clinical research expertise of
ECRON´s 20 years´ experience, with MAL´s association with India´s
largest medical University.
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.