Deciphar Life Sciences, the wholly-owned subsidiary of Bigtec, a research informatics major is gearing up to tap the global opportunities with its four offerings in clinical and drug research. It is now scouting partners for sales and technical implementation. It will include opening sales-cum-technical offices in the US and Europe, identify training and establishing a good partner network.

To begin with efforts are on to address the North America and Canada markets, which is carrying out BA/BE studies after which will it will look at Europe. The healthcare industry is expected to be one of the least affected by the downturn. Research activities in the Pharma industry cannot come to a halt. Since pharma research has a 'fail fast' metric, the use of software from Deciphar will help them be more sure footed, regulatory compliant and get accurate results. Major industry trends such as the ever-important need of accelerating the drug discovery process, the shortage of trained manpower and the outsourcing of clinical trials are well suited to the adoption of our products, G Sampathgiri, director, Deciphar, told Pharmabiz.

The entry into the global market is a first by an Indian software product in the pharma research space. Growing opportunities in the generics research space outsourcing, pharma-biotech and clinical research organizations (CROs) need to need to be equipped with an advanced software solutions. In fact all our products are a 'must-have' for customers because they will help bring in greater efficiencies and regulatory compliance process, he added.

The four products are 'ClinOne' for bio equivalence in clinical research is the flagship product, 'Ark' (Advanced Research Konsole) for the analyticals in clinical trials, 'Synthesys' for pharmaceutical chemistry research and an end-to-end solution in research management and 'Quark' a quality assurance tool.

Currently, ClinOne and ARK are faring very well. Both the products have multiple customers in India and one customer in UK. These include Wockhardt, Glenmark, Manipal AcuNova, Lupin, Veeda Clinical Research in Ahmedabad and now under implementation at Veeda UK. Synthesys is well past the conceptual design validation stage and is on the development roadmap. Quark already has two customers and is in the final stages of procurement with a few government agencies.

Regulatory agencies will also need to adopt and even mandate use of ClinOne and Ark since these will help assess and monitor trials closely, stated GM Kini, director, Bigtec.

Customers need to invest Rs 45 lakh to install ClinOne and Ark. The modular offerings are available at Rs 10 lakh.

Globally, there are more than 1200 clinical research organizations and 250 Pharma companies with clinical research facilities which is the total market size for ClinOne and ARK. While the products are aimed at the international market, the Indian market has equally demanding customers, stated Sampathgiri.

Most of the software products in the clinical trial space cater phase-II to phase-IV and focus on Electronic Data Capture (EDC). But the phase-I and BA/BE trials space is a largely vacant niche and leapfrog from the traditional EDC to an integrated process-enabling solution. ClinOne complements rather than competes with players such as Oracle and Phase Forward. For Quark, Labware is a competitive product.