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Clinical Navigation

Over the last decade within pharmacovigilance, significant developments and improvements to regulations have been made. With the revision of regulations occurring within multiple countries and regions, the pressure on sponsors/marketing authorisation holders (MAHs) to be knowledgeable of and abide by these is an ongoing challenge. Outsourcing different tasks and responsibilities is one available option. CROs are often able to provide sponsors (and/or MAHs within said sponsors) with greater global reach through coverage in multiple countries and take a proactive approach to remain knowledgeable on the current pharmacovigilance regulations to properly advise sponsors. Furthermore, CROs not only have the ability to advise sponsors, but also the skills, processes, systems, and resources to be able to adhere to this continually changing and costly environment, while still providing a high-quality service and maintaining compliance.

A shift in dynamic has been marked from the typical clientcontractor relationship, where sponsors may now see CROs as their collaborative partner and, essentially, an extension of their company. CROs must recognise that each sponsor may have different needs and expectations and therefore appreciate the need to be flexible, while still remaining compliant with all regulations as the ultimate responsibility for pharmacovigilance activities remain with the sponsor. However, the willingness of sponsors to listen to advice from CROs and make informed decisions on best practice means that they remain compliant. This article will explore several instances where CRO support may be required by sponsors.

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Nick Barker is a Director of Clinical Safety for Medpace, working closely with sponsors to support adherence to regulations. He has experience in pharmacovigilance across all clinical trial phases for various indications, as well as post-marketing. Nick’s key interests lie in the translation of regulations into processes, through the development of procedures and process improvements.

Katharine Colbert RN, BSN, MSBM, MPH, is a Senior Safety Manager at Medpace with a strong clinical background in paediatric oncology/stem cell transplant. With 17 years of industry experience, she has extensive global knowledge in various therapeutic areas within both clinical safety and post-marketing pharmacovigilance.
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Nick Barker
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Katharine Colbert
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