Ecron AcuNova has set up the Functional Services Development Centre (FSDC) where the company has slated an investment of Rs.1.5 crore to Rs.5 crore. The funds are sourced through internal accruals. The new facility will also hire 50 personnel taking the total manpower strength from 320 to 370 people.
The new facility will focus on Clinical Data Management and Drug Safety & Pharmacovgilance. Clinical trial allied services including Medical Writing (MW) and Pharmacovigilance (PV) have witnessed growing interest from big pharma companies. Hence the need to create scale-up was mandated, D A Prasanna chairman & managing director, Manipal Acunova Ltd. told Pharmabiz in an email interaction.
The new facility is at Whitefield at Bangalore where the company is headquartered . The total area is 7,000 sq ft with an option for scale up going by the growth in demand. “We have been rendering these services for the past four years in India and much longer in Europe. The intensity of selling these services have increased in the past one year,” he added.
The fully validated OC safety management software at Frankfurt and Bangalore, electronic submission in EU format to regulators and a highly experienced medical and drug safety professionals in the company are some of the key differentiators in the company, according to the Manipal Acunova chief.
The Rs.100 crore Ecron AcuNova is also evaluating inorganic growth efforts in the space. Compared to competition, the company has managed its acquisitions well, which is has led to robust growth. Its leadership status in highly specialized areas like imaging agents and stem cell research have led to repeat business orders from its clients in India and Europe. The new expansion of medical writing and pharmacovigilance though its Functional Services Development Centre will see it generate $3 million(Rs.13.32 crore) through top line growth, he said.
The total value of the Indian clinical research industry is estimated at Rs.8,000 crore (US$ 2 billion) . In this sector, scalability has been an issue because of the fragmented nature of this industry. Many players find it difficult to get contracts. The challenge of regulatory delays are hurting the competitiveness. It is being viewed that industry consolidation will take place within the next three years, stated Prasanna.
Among the visible trends are that Indian software companies like TCS, Cognizant and Accenture India have grown in data services outsourcing faster than the local and global clinical research organizations . Another observation is that sponsors are preferring ‘Regional CRO’ to ‘National CRO’.
There are also challenges in the clinical research space going by the recent warning letters from the FDA to big pharma companies and the clinical research organizations on source data verification. These indicate the stringent expectation of accountability across countries which makes the pharma companies reassess their CRO options, pointed out Prasanna.