| Sameer Jain of HCL Technologies evaluates how offshore outsourcing will drive industry innovation and safeguard product development data
The years ahead will see testing times for the pharmaceutical industry. Companies face the dual pressure of continually bringing new products to markets whilst engaging in careful cost reduction. As ever, this is set against a background of rigorous compliance requirements. Managing innovation is the top concern for many pharmaceutical companies because drug research is highly time- and resource- intensive. Eighty per cent of investment in new drugs fails to deliver a return because the drugs fail during the development process and never make it to the marketplace.
Drug development trials are resource-intensive and require precise documentation to track all research processes. All changes and modifications have to be carefully documented for safety and compliance reasons. The documents are an essential part of ensuring the safety and effectiveness of new medicines. But handling all the data involved in compliance can be an overwhelming task. Consequently, pharmaceutical companies are demanding maximum quality, reliability and visibility into how day-to-day activities are tracked. Clinicians who are responsible for researching new drugs are concerned with the integrity and security of data. Confidentiality is paramount and a watertight security policy needs to be enforced.
Having an appropriate IT architecture in place to help handle these pressures is more important than ever. Companies cannot afford for IT to be the weak link. Yet a pharmaceutical company’s core competency is getting drugs to market and not the storage, version control, risk management and auditability of data. So what will enable organisations to comply with regulation and yet continue to drive innovation?
One of the solutions is outsourcing. To date, pharmaceutical companies have been hesitant to outsource because of concerns about intellectual property protection, regulatory compliance and business continuity. However, the benefits that can be realised through outsourcing can no longer be ignored, and a growing number of pharmaceutical companies are now evaluating the steps that need to be taken when selecting a supplier. |
