In an effort to pursue its next level of growth efforts, the three-year-old Lotus Clinical Research Academy (LCRA) is looking to raise funds via the private equity route. It has assigned Ernst & Young which is in the process of preparing the projections and plans of the academy, after which potential PE players will be identified for discussions.

The funds will be utilized to further augment its training and services business. Among the focus areas include Pharmacovigilance, Sudhir Pai, managing director, Lotus Clinical Research Academy told Pharmabiz.

In order to be way ahead on the training front, the company installed the entire Oracle suite of products which is being put to use by its services business arm.

The focus of the services division which has 40 experts is data management, pharmacovigilance and phase IV trials. It has completed two projects and is now in advanced stages of discussion for another two more assignments with reputed clinical research organizations (CROs). The services division chips in 50 per cent of the total revenues for the Academy.

Further, LCRA is also engaged in carrying out compliance audits on behalf of the global pharma companies of large sites assigned to carry out human studies. It has completed audits for over 60 trial studies dealing with US FDA and EU submissions. "Based on its experience and expertise, more such assignments are coming our way," stated Pai.

It has tied up with the 750-bed Yenepoya Hospital at Mangalore to set-up a clinical unit. LCRA is managing and coordinating human studies. Plans are to extend the same to other hospitals. Since many hospitals in the country do not have clinical trial exposure, LCRA is also working with hospitals to set up Ethics Committee, Scientific Review Board and train the hospital staff for conducting clinical trials.

With pharmacovigilance being the future for clinical research sector and India being sought-after for backend services, LCRA is in the last lap to talks with a foreign partner for a joint venture in the pharmacovigilance space.

Global companies are keen to set up pharmacovigilance centres in India primarily because of the economies of scale and skills. More over a number of Indian CROs have proven capability in quality deliverables in human studies and pharmacovigilance is an extension of this which covers reporting of adverse drug reaction (ADR) and post marketing surveillance. The standard operating procedures of Oracle AERS, a dedicated pharmacovigilance software are being put into place as pharmacovigilance projects will take off in November this year.

The Vioxx drug fiasco has led to the need for stringent pharmacovigilance. Current estimated cost per annum for each drug reporting is around $100,000. This indicates the potential in the field. Information Technology majors TCS, Infosys and Satyam are earnestly into pharmacovigilance, added Pai.

Comprehending the promising prospects in pharmacovigilance and the acute shortage of trained personnel in the field, Lotus is offering a MS degree in clinical research and pharmacovigilance at the Birla Institute of Technology, Ranchi. The Academy is training personnel and is looking at partnering with experts to carry out projects.

The Bangalore-based LCRA has started operations in Chennai. Based on the success of Chennai branch, more centres will be set-up at Mumbai, Ahmedabad, Hyderabad and New Delhi. It is offering live projects to students who can now have hands-on-training at hospital clinical research sites.