A clinical trial (“study”) is the process by which a new or existing medication is tested in order to gather the information required for the FDA to make an informed opinion regarding the suitability (safety, effectiveness) of the drug to be marketed to patients for treatment of a specific condition.  A drug will move through many clinical trials prior to submission to the FDA.

A typical study will involve many participants and multiple study centers around the country or world. Participant rights and safety are paramount in the design and execution of studies, with staff being specifically trained and often certified in the methodology of human subject protection. Additionally, studies are submitted to both the Food and Drug Administration (FDA) and an Institutional Review Board (patient’s rights advocacy) for review and approval prior to the recruitment and enrollment of participants.

Pinnacle Trials

(256) 236-0055

Studies typically include laboratory work, physical exams, and diagnostic testing, as well as the investigational treatment being studied. There is no cost to participate in a study and participants are generally compensated for their time and travel. Investigational medications may be the first of its kind (a new class of medication), of the same class as an existing medication, or may be an existing medication that is being tested in a condition different than that for which it has been approved.

Most studies consist of a series of visits to a clinic over a set period of time (maybe weeks or months), during which time the participant is monitored very closely and information collected to track the safety and effectiveness of the drug being studied. Study visits are usually more thorough than routine doctor’s visits because of the increased observation and care required by the study. Studies are overseen by physicians who are experts in their field of research.

In 1998, the Pinnacle Research Group was founded in Anniston, Alabama by experts in clinical studies. The company objective is to be an asset to the community by conducting clinical studies expertly, ethically, and well suited to the local population. Since its inception it has been just that, having successfully enrolled over 1,000 patients into 200 or so studies over a broad range of medical conditions.  The 17 person staff endeavors to make each study a positive experience for participants and most who do join a study have just that, and commonly enroll into additional studies that follow. As a result of Pinnacle’s work, patients have had access to a level of care and oversight that would likely not otherwise be available, access to education and information beyond what they might typically receive, and access to medications that could not get outside of a research study.

One of the founders of Pinnacle Research Group is Tracy Sims, a certified, 28 year veteran of clinical research. She is currently the Managing Partner of Operations and oversees all of the staff and ongoing research projects. In her 28 years she has experienced great changes in the industry, and has taken the necessary steps to stay ahead of a rapidly changing environment. “These changes are expected in any industry, and especially one that involves the enrollment of patients into studies. Research is a dynamic and evolutionary industry and it places great demands on research centers such as ours. For every hour we spend with a patient we probably spend three or more on administration, much of which is training. We strive constantly to stay ahead.”

Whitney Hartley, the Administrator of Pinnacle Research Group is currently seeking an additional staff member due to increased demand of the company’s services. Those who are medical assistants or LPN’s are encouraged to contact her at 256-236-0055, extension 102.

See our sidebar for qualifying factors for test currently enrolling. Qualifications change, so stay updated via the company website at pinnacletrials.com or by calling the office at (256) 236-0055.

Pinnacle is currently enrolling subjects who have been diagnosed with:

Diabetic Foot Wound

Type 2 Diabetes

Rheumatoid Arthritis

Systemic Lupus

Inguinal Hernia Surgery

Diabetic Neuropathy

COPD/Emphysema

Chronic Constipation

Benign Prostatic Hyperplasia

Psoriasis

Eczema

Pinnacle Research Group

321 E. 10th Street

Anniston, AL 36207

(256) 236-0055

pinnacletrials.com