Thanks to the much-lauded IT success story, offshoring clinical data management (CDM) to India is thriving. The rather new CDM industry already has quite a few big names figured in it. Pfizer, for instance, has a multi-year alliance with Cognizant Technology of Chennai (southern India) in CDM and biometrics. The world’s top drugmaker seeks to capture the “cost-advantage factor that India offers.” Wyeth, through a pact signed with the Bangalore-based Accenture way back in 2000, made the latter its exclusive partner for 10 years.

With a global clientele list of Novo Nordisk and Sequenom on various data solutions, Tata Consultancy Services recently secured a multi-million dollar contract from Eli Lilly for CDM, statistical analysis and medical writing. And as part of its most recent deal, TCS is setting up a global drug development centre in Mumbai to support GlaxoSmithKline’s drug pipeline. TCS is expected to provide a variety of CDM services including clinical submissions for the UK firm. This Indian IT behemoth maintains about 2,700 employees in its life sciences practice, which accounts for about 4% of the company’s total sales. Other stalwarts in this field — Infosys, Wipro, Satyam — are zealously getting involved in CDM services.

“Clinical data management represents an opportunity for India to graduate in the value chain in the information technology enabled businesses,” avers Mukesh Ambani, chairman of India’s largest corporate house, Reliance Industries (RIL). The RIL promoted Reliance Life Sciences is reportedly building a huge CDM facility in Bangalore, India’s IT hub.

A Varied Mix

Even as IT companies expand to life science business operations, emerging clinical research services providers are turning even more aggressive. CROs invest huge sums to upgrade infrastructure with validated software such as SAS, Oracle Clinical and Clintrial in compliance with 21 CFR part 11. More than half of CRO vendors have CDM operations.

Generally, CDM services are rendered on three broad categories. Project-level contracts are the usual model for individual studies. This normally depends on the providers’ systems and processes. When the requirement is large, where sponsors look for multiple studies, either the retained full-time equivalent (FTE) or the functional service provider model is preferred. The difference between these two models is primarily the level of control that the sponsor has over resources available to work on their projects. “The retained FTE model gives full dedicated control on resources for sponsors,” explained Dr. Chetan Tamhankar, chief operating officer of Mumbai-based SIRO Clinpharm.

Specializing in late-stage clinical development solutions, Siro claims to have managed over 200 projects for CDM, statistical analysis and report writing. Besides partnering with Pfizer in end-to-end CDM and biometrics services, this emerging desi CRO has a joint venture with U.S.-based pharmaceuticals services group InVentiv — Ventiv-Siro (India) — focussing on large-scale functional offshoring work.

Global CROs and pharma giants also share the varied Indian CDM landscape. Quintiles Transnational Corp., the CRO giant, has a dedicated data management set-up at Bangalore. Several MNCs including Pfizer, Novartis, GSK also have in-house data management operations.

Concerns on IP Safety

CROs graduating from data entry to processing, design and programming also add to numbers. Of late, electronic data capture is in vogue and most of the CROs look to make the switch from conventional paper formats. Though a range of services are offered, intensive processes like data validation and clinical coding are not extensively outsourced.

With enormous IT resources, skilled manpower and cost benefits, the subcontinent is high on the radar for CDM offshoring. However, a certain level of apprehension seems to lurk in some innovator firms that desire an Indian flavor. Despite an improving IP climate, fortified patent laws and reinforced GCP guidelines, concerns of adequate safeguards for generated data remain. Companies also fear the safety of highly sensitive trial info submitted for regulatory approvals. The new patent law is yet to shield the data with a foolproof mechanism. “A built-in system, something like ‘Data Protection Act,’ is the need of the hour to address these concerns,” commented Dr. U. Sahoo, managing director, Chiltern International (India).

The quality of originated data is yet another issue. A dearth of ready-made, better trained and software-enabled personnel, lack of mandatory auditing practices, etc., seem to fuel such a notion. CDM service providers, nevertheless, counter this view, arguing that the majority of CDM work currently being sourced to India is meant for highly regulated markets. Plus, there is ample proof of acceptance of India-generated data by the world’s most stringent regulatory bodies from the U.S. and EU regions.

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.