Formed in 1998
Pinnacle was formed in 1998 by founding members Tracy M, Sims CCRC, and Darin K. Sims MBA. We are a single-site, multispecialty clinical research and trial management organization. We manage the recruitment, enrolment, and randomization of both healthy and patient populations into phase I-IV industry-sponsored clinical drug trials. We conduct clinical trials over a broad therapeutic area, with particular interest in early phase development projects. We have a highly skilled and experienced permanent staff team of medical professionals.
We are a dynamic organization able to respond to industry demand, and since early 2021 we have combined our standard multi-therapeutic research with the recruitment and enrollment of infected and symptomatic patients in COVID-19 studies. Studies have included phase I, II, and III studies (of both outpatient and hospitalized severe cases). Our excellent enrollment and robust data have been rated the best by our sponsors, and as a result we have been submitted to the FDA to act as the sentinel center for the phase III study of one of our sponsor’s antibody drugs.
COVID-19 research presented us with unprecedented challenges including the adaptation of a new indication, very tight timelines for start-up and enrolment, complex study design, frequent and intensive date review and lock, and the sourcing of specialist equipment and supplies. Thanks to our highly trained and experienced staff, organizational flexibility and resourcefulness, and our experienced and committed clinical investigators, we were able to successfully meet these challenges.
We maintain a staff of dedicated research personnel. New staff receive a minimum six-month training period (and up to one year) prior to assuming full responsibility for their position. The training is extensive, based on the considerable experience and expertise of our current staff, and staff must demonstrate proficiency under supervision before they are approved to perform tasks unsupervised. Our rigorous training methods mean that our staff are considered sector-leading by our industry partners, and our error rate is typically the lowest amongst sites participating in multi-center projects. Our staff retention is excellent (an average 8.5 years length of service) and the majority of our staff and investigators are certified in clinical research by the Society of Clinical Research Associates (SOCRA – Certified Clinical Research Professional)
We are located in Anniston, Alabama, part of the Anniston-Oxford metropolitan area with ~120,000 residents. Our facility is strategically located midway between Atlanta, Georgia, and Birmingham, Alabama. Due to its regional healthcare facility, the Northeast Alabama Regional Medical Center, healthcare is the largest industry in Anniston. As well as the city population, Anniston is surrounded by a large rural population that seek medical treatment in the Anniston area. Our site database includes approximately 60,000 patients.
Our reputation is the backbone of our organization, and our exemplary work, ethical working practices, and excellent results mean that we are held in high regard by both our industry partners and our local community. Our DUNS business rating is consistently high, and we have been audited three times by the FDA with no cause for remediation or issuance of form 483.