Astrum

Astrum’s services and expertise in clinical development span the entire development cycle, ranging from first in human to post-marketing. Our in-house experts and wide network of partners will advise you every step of the way on the entire clinical development process.

We’re committed to providing the optimal plan and study designs that meet your scientific, medical, and business goals.

Our consultancy services can help you move your projects forward quickly and effectively from bench to bedside, as proven through several successful projects.

Our experience includes:

• Defining and implementing the preclinical, clinical and regulatory plans for new medicines, medical devices and other health products.
• Supporting the process of obtaining scientific and regulatory advice from competent regulatory authorities, including US FDA, EMA and national EU regulatory authorities.
• Preparing the investigator’s brochure and investigational medicinal product dossier (IB, IMPD).
• Preparing and submitting the clinical trial application (CTA) to the competent authorities and ethics committees.

At Astrum we fully understand the challenges faced across the development process, especially for smaller research companies and we’re committed to help you overcoming them as efficiently as possible.