Phase I / IIa

From first-in-human to proof-of-concept, Eurotrials offers solutions for your early phase or phase I studies. With specific partnerships and close relationships with local centres, we deliver the strong support you need in the start of your journey.

The strategy chosen form the beginning is very important and will influence all the project deadlines, budget and ultimate success. This is why early phases / phase I should be well strategized and managed. Our multi-disciplinary teams of regulatory strategists, project managers, market access specialists and biostatistitians, among others, have experience in completing projects on time, on budget and with the compliance expected from a partner of excellence. Eurotrials has to offer:

  • Data Management, Biostatistics, Clinical Monitoring & Medical Writing
  • Identification of suitably experienced Phase I units
  • Medical advisory services for protocols & investigator brochures
  • Preparation of regulatory documents for regulatory authorities
  • Medical Safety (Pharmacovigilance & Medical Monitoring) including adverse event case processing, set-up of electronic reporting systems, and set-up and representation in data safety monitoring boards/institutional review boards
  • Quality Control/Assurance
  • Food effect studies
  • First in man, dose escalation, PK/PD
  • Multiple dose studies
  • Drug interaction studies
  • Bioavailability, bioequivalence
  • Phase I patient studies
  • Special population studies
  • Proof of concept studies

Eurotrials partners with Kymos CRO to provide a single offer to the biopharmaceutical industry, from the preclinical stage to the marketed products. The combined geo-footprint of this partnership opens both companies to new global opportunities. This complementarity allows a better service offer to all biopharmaceutical industry in the development of clinical research projects.