Overview

CSM's Subject Retention & Compliance Services employ a team of Clinical Trial Research Pharmacists (CTRP^®) who serve as a critical communication link between all clinical trial stakeholders (sponsors, CROs, investigators, subjects) throughout the trial, 24 hours a day, 7 days a week. CTRP are licensed pharmacists with expertise in clinical trials, drug issues, compliance, and subject counseling.

In the typical clinical trial, communication flow is linear:



With CSM's CTRP services, communication is cross-functional, reciprocal, and frequent:



Since sponsors cannot communicate directly with patients, CTRP act as a secondary line of communication between the sponsor, investigator, and all subjects.

CTRP get involved prior to the start of a clinical trial. They meet with the sponsors and CRO, review the protocol, and identify potential compliance issues. At the start of the clinical trial and at pre-scheduled times during the study, CTRP contact subjects by telephone, reinforce important study information, and counsel subjects on topics such as:

• Proper dosing and storage of study drug
• Proper use of devices
• Use of concomitant medications
• Dietary and life-style issues that may affect study drug
• General clinical trial information

CTRP are also available 24 hours a day, 7 days a week to respond to calls from subjects, investigators, sites, and sponsors. All discussions between CTRP and subjects are documented and forwarded to the investigator upon completion of each contact.

In addition to CTRP services, CSM^® provides site training, develops training media such as videos and DVDs for subjects and sites, and assists sites with following up on subject IVR reports.