Adequate Monitoring of Clinical Trials is imperative in assuring safe subjects, quality data and a well-executed study. Clinique Research Services, Inc. provides comprehensive site monitoring including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. Our CRA’s act as a liaison between the site and the study teams. Monitoring visits are conducted at pre-determined intervals and/or as the study dictates.
Project Management & Regulatory Services
Effective Project Managers are essential for managing the study team and meeting project time-lines. Clinique Research Services, Inc. provides full project management support by assigning a Clinical Project Manger to communicate and manage all study activities. There are 75% of Clinique Research Services, Inc. consultants which have project management experience from previously held industry positions.
- Recruit investigators through our direct contact and in-house investigator database
- Train investigators and site personnel
- Help the investigator in screening patients
- Assisting investigators in the Informed Consent Process
- Coordination and management of laboratory samples, courier and follow-ups of lab reports
Clinical Research Training
Clinique Research Services, Inc. will personally train the investigator, study coordinator and study monitor on both US FDA 21 CFRs and clinical trial regulations to ensure collected data meets filing requirements in those countries.