Investigator-initiated studies

Over the past few years, there has been a significant increase in interest among pharmaceutical companies and physicians in this type of clinical trial – Investigator-Initiated Study (IIS).
And no one doubts that all of the regulatory requirements for human trials apply to such trials.

These requirements formed a special approach for planning and conducting Investigator-Initiated Research, when at the concept stage the specifics of local and international legislation, approaches to data collection and processing, biostatistics, management, monitoring, and the role of the study in the entire lifecycle of the medicine should be taken into account.

The X7 Research staff has extensive experience in planning and conducting investigator-initiated studies and is available to assist at all stages.

DEVELOPMENT OF MEDICAL DOCU-MENTATION AND STATISTICAL ANALY-SIS PLAN

DATABASE CREATION

SUPPORT ON ALL STAGES OF THE STUDY

The X7 Research team has extensive experience in post-marketing trials in Russia, EAEU, CIS, EU. We work by the most up-to-date legislative requirements in the sphere of drug circulation.

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