About
Mission Statement
Our values are at the heart of our organization, in the work we do, and the way that we do our work. We never compromise or deviate from our values. To provide the highest standard of care we can for our participants by adhering to methods that have refined our the course of our existence. We are dedicated to the advancement of medical science through robust clinical research and to protecting the rights and welfare of our participants. Our pillars of success include taking care of the patients, our people, and our community. As a result of our values we know that the research conducted at our site is reliable and leads to better decisions by sponsors and regulatory on the drugs and devices we study.
Diversity
We celebrate diversity
Inclusiveness
We are an inclusive organization
Transparency
We are guided by open practice and policies
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, multi-specialty clinical research and trial management organization. We manage the recruitment, enrollment, 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 enrollment, 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.
Team
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)
Operating Environment
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.
Reputation
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 four times by the FDA with no cause for remediation or issuance of form 483.
Managing Partners
Our two Managing Partners are responsible for the daily operations of the organization, overseeing our clinical research program, and taking responsibility for finance, contracts, and business development.
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Research Team
Our clinical research team coordinates and runs our clinical trials and are a highly trained, highly skilled team with specialist knowledge of a broad range of sub-specialties, giving us the capacity to conduct clinical trials and research in most therapeutic indications.
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Supporting Staff
In addition to our Research Team, we also employ highly qualified professionals as Study Coordinators, Regulatory Coordinators, Registered Nurses, Research Certified Investigators, and Member PRN Staff.
Pinnacle Clinical Trials Experience
State-of-the-Art Research Facility
Our state of the art testing facility has been vetted by multiple Institutional Review Boards, our sponsors, and the Food and Drug Administration. We proudly maintain an exceptional record of review with no citations or remedial actions. Our premises feature a 13,600 square foot Phase 1 Facility with 16 beds, 3 living areas, kitchen, laundry, and more.
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