Study design

Study design is a critical step of clinical studies. The study protocol, investigator’s brochure and all related documents need approval of the National Agency of Medicines and Medical Devices and the Ethics Committee.

 

Our specialists are experienced and trained in the field of documentation design and hand-in, elaboration of requested notes and amendments , as well as all related activities.

 

Our team of clinical pharmacologists, specialist and primary physicians in multiple domains, emergency physicians and pharmacists are at your service for the following:

  • Risk-benefit evaluation
  • Evaluation of deontological aspects
  • Evaluation of scientific value
  • Evaluation of ethic value
  • Elaboration of clinical study protocol
  • Elaboration of investigator’s brochure
  • Elaboration of clinical study authorization request
  • Other types of activities