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As we know, clinical trials represent up to 45 per cent of the cost of bringing a new product to market. The stakes are high, not only because of the massive costs, but also due to the fact that being the first to market represents a huge financial and competitive advantage. Since patents are issued before a drug goes to trial, the faster pharmaceutical and life science companies can bring products to market, the longer they will enjoy sole distribution before competing against generic alternatives. In this article, we will discuss the role that technology, and specifically a risk management information system (RMIS), can play in streamlining the launch and management of clinical trials, as well as creating a holistic approach to managing risk.
INCREASED GLOBALISATION, INCREASED INSURANCE
Over the past five years, the number of clinical trials worldwide has grown dramatically, and has expanded to locations all over the world. As companies move trials beyond their home country, they are faced with complex insurance requirements. Missteps in the placement of insurance can delay or disrupt clinical trials, with costly financial implications.
For example, in many countries, companies must include a certificate of insurance in their regulatory filing package. In many cases, certificates must be issued by a locally licensed insurance company and written in the local language – typically increasing the turnaround time for certification. Delays or errors in certification can result in delays in regulatory filings and approvals by ethics committees, ministries of health, oversight authorities and government agencies such as the FDA. |
