Associates for Clinical Trials Management (ACT Management)
ACT Management provides monitoring services of multicenter clinical trials for Sponsors, Sponsor-Investigators (SIs), or CROs. With a team of experienced program directors, clinical research associates/monitors and regulatory specialists, PEER can help ensure that a clinical trial is appropriately monitored for compliance with Good Clinical Practice (GCP), FDA regulations (21 CFR Parts 50, 56, 312, 812), and the research protocol. PEER can also assist with site-initiation visits, filing of annual reports to FDA, and responding to regulatory challenges.
Our monitoring will not only account for compliance with GCP and the protocol, but can also provide data on a regular basis to the Principal Investigator (PI) and/or the Coordinating Center on recruitment, the total number of missed visits, missed assessments, and protocol deviations at a given site and across all sites.
ACT Management can help ensure success of your clinical trial by providing effective communication between the PI or Coordinating Center and the performance sites. Through effective oversight monitoring and communication, ACT Management can help ensure that your trial meets its scientific objectives and deadlines.
- Medical Writing/Drafting Protocols
- Consultation on Ethical Design of Studies
- Consultation on Interacting with FDA
- Development of Case Report Forms
- Assessment and Development of New Sites
- Site Initiation Visits for Investigators
- Education and Training of Investigators/GCP Training
- Enhancing Capture of Data and Endpoints
- Site Monitoring
- Preparation for Audit and Clean-up of Data