Phase II trials

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

Phase II trials are planned after the drug has demonstrated acceptable safety profile in phase I study. The main objectives of these studies are safety evaluation, selection of treatment regimens and doses in a certain nosology.

Phase II studies are sometimes divided into:

Phase IIa – studies in a small homogeneous group of patients (20-40 people) with a particular disease to evaluate the safety and preliminary efficacy. Optionally conducted to assess the potential of the drug in the nosology (proof of concept).

Phase IIb – trials in small groups of patients with a particular disease. In this phase the treatment regimen and/or selection of the doses of study drug are evaluated for safety and early efficacy. Such studies usually involves several small therapeutic/dosage groups of patients (usually from 100 to 300 in total). According to the results of such studies the Sponsor chooses therapeutic doses and administration regimens for further research.

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

If necessary, we involve our network of referral clinics, provide sites with trained personnel for non-medical work, as well as help to obtain necessary approvals and training for naïve sites which have rare target patient populations.

In general, to obtain regulatory approval the following documents are required:

  • Information on the composition of the drug
  • Certificate of Analysis
  • Reports of clinical trials in phase I
  • Clinical development program
  • 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