Medfiles offers comprehensive clinical services for medicinal products, medical devices, and for food and nutritional products. We support study sponsors during all study phases from I to IV on medicinal products.
We provide flexible solutions or a complete packages extending from study planning to final reporting. One-stop solutions are available including project coordination, protocol preparation, study set-up activities, essential study documentation, monitoring, data management and statistics and final study reports.
We also provide flexible solutions for investigator-initiated and non-interventional studies. We perform studies to substantiate health claim dossiers and novel food applications in the food area according EFSA requirements. Our deep knowledge in the medical device area ensures that studies meet the recent requirements set for clinical investigations of medical devices for human subjecs according ISO 14155. We have dedicated SOPs for clinical investigations of medical devices.
Our services also include formulation development, manufacturing of investigational medicinal products (IMPs), QP certification, development and validation of analytical methods and stability studies for IMPs.
All of our personnel undergo continuous training and professional education based on the latest regulatory requirements by various governing bodies such as the EMA and the FDA, ensuring the highest quality services available.
We have vast experience from various therapeutic areas: