Quality research experience and a deep skill base are essential for the successful execution of clinical trial reclamation projects. These represent the foundation of RESQ’s services. In fact, RESQ’s roots are in the practice of reclamation projects. RESQ reclamation projects are where our peoples’ interpersonal skills, detail orientation, efficiency, and deep operational expertise are of their greatest importance.
The need for reclamation projects can cause financial and operational stress to the Client. Corporate timelines also require adjustment. RESQ will work quickly, efficiently, and cost effectively to correct all applicable project deficiencies to help ensure compliance with FDA CFR/ICH/GCP Guidelines, IRB, and Client’s SOPs, corporate policies, and procedures. In the process, we will demonstrate respect for the Client’s and Investigator staff’s sensitivities while successfully working to bring the Client’s project back on track.
Reclamation Projects Require a Special Quality of Staff
In addition to possessing all the RESQ-required education and experience requirements associated with their respective positions, staff who participate in reclamation projects must all have Bachelor’s degrees and are often RNs or possess advanced scientific degrees. They must have a demonstrated knowledge of Good Clinical Practice (GCP), 21 CFR 312, and ICH Guidelines with at least 10 years of experience in clinical monitoring, drug safety, data management, and/or GCP QA.
RESQ reclamation specialists pay special attention to clinical operations detail and processes. They will have knowledge of the projects specific therapeutic area by education and/or experience. They must have previously demonstrated their excellent communication, documentation, and organizational skills, and also, their ability to thrive within a team atmosphere.
This is no time for “First Timers”
All deployed RESQ reclamation project staff will have already participated in a reclamation project or will have been mentored by a RESQ experienced reclamation project veteran.