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International Clinical Trials

Speeding Clinical Trial Processes Through Greater Agility


Life science organisations, in common with other businesses, are looking urgently towards technology to help them become more agile. Traditional ‘transformational’ projects that take 12-24 months – or even more – are no longer practical as businesses are unlikely to see immediate benefits. In a regulatory context, this is often the case given that global compliance is a moving target. Requirements are continuously being updated and supplemented.

This makes it impractical to try to define all probable needs upfront, then lock down an IT project and go through all the rigorous sequential stages of designing, approving, developing, validating/testing, piloting, and rolling out. By the time that end point comes, there is a strong possibility that needs will have changed and new regulatory requirements will be coming through. This then necessitates a new round of modifications and additions – incurring more delay, cost, and frustration.

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About the Author


Romuald Braun is VP of Strategy for Life Sciences at Amplexor. He holds a Master’s degree in Drug Regulatory Affairs, an Engineer’s Diploma in Data Technology, and has spent the last 26 years working in compliance, document management, and content management related roles in this industry – in client-based as well as consulting and project management roles.

romuald.braun@amplexor.com
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