Study Design & Start-up

This area of services includes development of the investigational program, study designing, development of study documents, and medical writing.

Our team of internal and external experts, key opinion leaders and potential investigators, upon necessity, is actively involved in study designing to provide a state-of-art approach, ensuring that all the latest scientific and medical information, as well as all small details, are taken into account. Protocol and Investigator’s Brochure development is the next important part of the clinical project’s progress that our experienced writers do. ICF and patient information supplement the block of the essential study documents. CRF being a more technical document requires a lot of attention while developing; its structure and design are very important not only for a proper collection of the study data, but also must be investigator-friendly to decrease the amount of time to complete.

In the event that the Sponsor already has all or some study documents, it may still be necessary to make specific country adaptation, to review them critically to avoid any obstacles in the later stages of the study.

The start-up phase is the base for any clinical trial and shall be paid enough attention to because the quicker achievement of the study timelines is directly related to the quality of start-up activities. We concentrate on the importance of proper preparation of the trial, which in turn provides prompt approval by authorities, shorter clinical period, and, finally, the reliable data of clinical trial.