Study Start-Up Services

As a seasoned professional in Regulatory Affairs and Study Start-Up, I not only bring extensive theoretical knowledge but also thrive in hands-on submission activities. Whether functioning as a Country Study Start-Up Specialist or overseeing global submissions as a Study Start-Up Manager, I embody a pragmatic approach.

With a boots-on-the-ground mentality, I am your go-to expert for navigating the intricacies of local regulations. From crafting tailored strategies to executing flawless Clinical Trial Application submissions, I am hands-on in ensuring compliance and successful initiation.

In a managerial role, I am the driving force behind Study Start-Up services, either as a partner at a CRO or within a pharmaceutical company. My role involves not only supervising the activities of the CRO but also actively participating in the submission process worldwide. This dynamic approach ensures a seamless integration of theoretical expertise into practical application, fostering successful clinical trials globally.

You can book me as a hands-on freelancer for all your submission needs, both short-term and long-term. I thrive in a constantly changing environment, keeping a close eye on all aspects to ensure smooth processes.