Phase IV trials

Smooth Drug Development provides a full range of services for conduct of large multi-center phase IV clinical trials.

Phase IV studies are conducted to gather more information about the drug when used in certain groups, comparing its effectiveness with the existing treatment standards and/or assessment of drug interactions. In contrast to observational programs these trials are interventional and usually comparative.

We maintain business relationship with a number of partner investigational sites working in most common nosologies, which proved their ability for rapid recruitment and providing of high-quality data and documentation.

In general, to obtain regulatory approval for phase IV study the following documents are required:

  • Package insert
  • Investigator's Brochure
  • Clinical Study Protocol
  • Information for subject and Informed Consent Form
  • Information on compensation for subjects
  • Other materials for subjects
  • Insurance agreement for study subjects
  • List of investigational sites and CVs of principal investigators
  • Confirmation of application fees
A study is conducted according to the following general plan:

  • Clinical study feasibility
  • Essential documents development
  • Submission to Regulatory Authority
  • Site selection and contracting
  • Preparation of the central laboratory
  • Preparation of sites for the study
  • Programming and validation of databases
  • Investigator’s Meeting
  • Obtaining regulatory approval for the study and import/export
  • Logistics of investigational products and materials
  • Obtaining of approvals of Local Ethics Committees
  • Site initiation
  • Clinical monitoring
  • Medical monitoring and pharmacovigilance
  • Data management and statistical analysis
  • Quality audit
  • Development of the final report
  • Site closure