Business Accent

An Indian solution for global clinical trials

Abilash M R talks on the importance of information technology in the conduct of clinical trials.

According to the LeadDiscovery reports, the global clinical trials industry is currently worth an estimated $10 billion and has the potential for considerable growth in the future. Global revenues from clinical trials have increased by almost 15 percent in the last year and the industry is prepared for an extended period of healthy growth. The need for new and innovative drugs together with the willingness of the sponsors and venture capitalists to pool in large funds and the support of the technology have jointly contributed towards this boom in clinical drug research around the globe.

Information technology has become an integral part of clinical trials because of the need for accuracy, speed, confidentiality and usability of the data collected through the trials. Such IT solutions, clinical trials solutions, help sponsors of clinical trials manage all aspects of clinical study planning, data management, preparation, performance, and reporting. The components of such solutions are data management, document/content management and trial management. The leading global vendors of the clinical trials solution are Phase Forward, Oracle, Nextrials, Medidata and Data track.

The India advantage

Clinical trials in developing countries are growing. According to Centerwatch, it is estimated that 20-30 percent of global clinical trial activities are being conducted in developing countries. The Indian clinical trials market has grown from $35 million in 2002 to $120 million in 2006. The projected growth by 2010 is $250-300 million. The availability of a large drug-naïve patient population and well-trained medical professionals, coupled with sophisticated technological infrastructure has made India an attractive destination for conducting global clinical trials.

Even though the environment has been so favourable, Indian CROs and pharmaceutical companies always needed a clinical trial solution completely developed in India. The picture of Indian advantage of high-class infrastructure and technology at lower cost becomes clear only if such an IT solution is delivered and supported by Indian vendors.

Our offerings

Established in 1994, Megasoft is a transnational Intellectual Property-driven, product-based technology company that focuses on its expertise in the three growing sectors—telecom (XIUS), lifesciences (Afferenz) and IT services. Megasoft is a SEI CMM Level 4 company that operates out of USA, UK, Singapore, Malaysia and Germany, and in Hyderabad and Chennai in India. Megasoft is publicly listed in the Bombay Stock Exchange and the Luxembourg Stock Exchange. For the fiscal ending December 31, 2005, the revenues stood at Rs 115 crore (Rs 85 crore for full year FY 2004) and profits were Rs 20 crore.

With a wide spectrum of clinical trials solutions completely developed and maintained in India, Afferenz is transitioning from a hidden industry gem to one with a substantial market position. Far different from the major vendors of clinical trials solutions, Afferenz offers the ERP of clinical trials with four modules data management, document management, image management and trial management. The clients can use any or all of these modules since each module functions independently and also in an integrated manner. Afferenz is the only Indian company to offer solutions for all the four phases of clinical trials in three innovative pricing models—per trial usage model, subscription model and enterprise license model.

Acceliant

At the heart of Afferenz's offering is the Acceliant eClinical Suite, a comprehensive solution that offers users real-time efficiency, ease-of-use in trial design, unparalleled flexibility, regulatory compliance, and the unique ability to integrate electronic data capture (EDC), online image analysis, and document management with traditional paper-based processes. Depending on the clinical and business needs of an organisation, these solutions can be customised and utilised independently or integrated to provide complete, real-time data collection for every aspect of the clinical trial process, including eCRF generation, site, data, image, and document management.

By combining Acceliant with unmatched support and consulting services, Afferenz can help an organisation to simplify the clinical work flow process through a focused, single source partner; accelerate the clinical development critical path, while reducing the risk and cost of conducting clinical trials; facilitate early market release of a new drug or therapy within its patent life. The four modules /independent products of Acceliant include:

Data management: By integrating electronic data capture functionality with automatic edit checks, real-time data queries, and a complete audit log, Acceliant Data Management provides the tools needed to efficiently manage trial information. And although a paperless clinical development environment may be the clients' eventual goal, the Acceliant Data Management module helps the organisation to gradually and seamlessly integrate electronic data capture and traditional paper-based processes. There is no need to choose between EDC and paper. Acceliant Data Management is a proven solution that enables the client organisation to run EDC, paper-based, and hybrid trials.

Document management: Acceliant's Document Management module is a regulatory compliant document management application that enables you to upload, store, manage, and link trial documents with other clinical data in an audited, version-controlled manner on a central data repository. The Document Management module is tightly integrated with other Acceliant modules to provide trial participants a single, centralised online library for all clinical trial documents.

Image management: MedStudio, the Acceliant Medical Image Management module, integrates online digital medical images, such as MRIs, CTs, X-rays, and other radiological data, with patient CRFs generated in Acceliant Data Management and other essential clinical data and documents captured by the rest of the Acceliant eClinical Suite.

By offering the industry's only integrated data collection and medical image management workflows and analysis solution, Afferenz continues to define the future of clinical development through innovation.

Trial management: Afferenz's Acceliant Trial Management module provides a fully integrated global solution for co-ordinating and managing all clinical trial activities. With Acceliant Trial Management, bottlenecks and other underperforming areas within trials can be easily identified. In addition, Acceliant Trial Management's dedicated trial environment, messaging, task management, and calendaring functions facilitate real time, two-way communication during the conduct of trials.

The future and beyond

"As life sciences companies continue to rework their clinical research processes, it is essential that they find a 'partner' with the technology, support and services tailored to their clinical processes and business objectives. Our mission at Afferenz is simple—to combine technology with process to accelerate clinical development through efficient trial and data management," says Kallol Biswas, Vice President of Afferenz. "Acceliant has been designed with unparalleled flexibility to easily complement and leverage, not replace an organisation's existing infrastructure and technology investments. And by offering the industry's only integrated data collection and medical image management workflows and analysis solution, we continue to define and shape the future of clinical development through innovation. We look forward to building on our past experience and success to continue to meet each organisation's clinical requirements today and beyond," he adds.

(The author is the Marketing Manager of Afferenz (Life Sciences Division of Megasoft Ltd. He can be contacted at abilash.mr@megasoft.com)