Outsourcing Clinical Trial Safety Data Management

Manufacturing Chemist – Pharma

July/August 2014

Supriya Desai, Director Medical Safety Operations
Suhasini Sharma, Director, Medical Affairs

Ensuring safety and efficacy of pharmaceuticals and biotechnology products is one of the top challenges in the healthcare industry today. Drug withdrawals have further heightened the focus on drug safety with consumers and other stakeholders across the healthcare ecosystem demanding more oversight. Regulators across the globe are responding to these pressures by increasing their scrutiny and compliance requirements from the industry. Post-launch product withdrawals pose numerous risks to patient safety, besides being detrimental to business in terms of loss of revenue and credibility. A robust safety management approach during clinical development would help detect safety issues earlier in the product lifecycle and avoid subsequent debacles.

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