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The recent European Clinical Trials Directive, which took effect on May 1, 2004, radically changed the regulatory demands placed on biopharmaceutical companies planning to conduct clinical trials in
most parts of
Europe. The purpose of the Directive is to establish clear, transparent procedures to simplify and harmonize the administrative processes that govern clinical trials. It means that a Qualified Person in a licensed manufacturing facility is required to release clinical trials materials.
At Kendle, we’ve made sure our operations are fully prepared to meet the demands of the EU Directive. We’ll work closely with you to ensure all regulatory documentation is in place for Qualified Person release. We’ve also created the role of Clinical Regulatory Specialist, who is responsible for ensuring we’re complying with all the demands of the Directive.
We’re structured to deliver your clinical trial with excellence and provide upfront strategy (for example, multiple country study feasibility) to ensure the success of your project. This extends to prompt study start-up via quality site identification and qualified patient enrollment. In other words, we identify the right sites and patients for your study to ensure its success.
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