Coastal Clinical Research, Inc. (CCR) is an independent multi-specialty research site. Since 1987, quality and patient safety have been at the heart of CCR. Through our highly experienced investigators and driven staff, we continually strive to improve through ongoing industry training and implementing our own quality program. This program includes monitoring our own metrics and ensuring study compliance with ICH and GCP guidelines, FDA regulations, study regulations, and CCR’s own standard operating policies. The fact that CCR has gone through five FDA audits without any 483s issued, and being a preferred clinical research site with numerous CROs and Sponsors, demonstrates to some degree the culture of quality found in our work and in the patients we recruit.
Our dedicated clinical research coordinators are integral to each study. Most of our CRCs are certified through ACRP and all are FAA certified for hazardous shipping. We provide our coordinators with clinical and administrative support so their focus can be patient safety and quality data for each study.
Our support staff allows for quick study start-ups and on-time delivery without compromising quality and data accuracy. Our full time support staff includes a Regulatory Specialist, two Patient Recruiter Specialists, a Clinical Laboratory Technician, a Nurse Practitioner, an Assistant Coordinator, a Data Coordinator, a Receptionist, and additional administrative personnel for site operations. Our team is metric driven and focused on meeting Sponsor’s expectations by delivering the expertise and services below.
Providing each staff member with ongoing industry-led training is a fundamental factor in CCR’s success. Each staff member receives GCP and ICH training biannually through CITI Program. An annual review of CCR’s SOPs ensures our procedures reflect industry standards. We remain active with the Institutional Biosafety Committee (IBC) with Biosafety level two approval. One requirement is to have exemplary OSHA compliance with training each year. Our staff is also HIPAA trained in research guidelines and compliant with all applicable HIPAA mandated requirements.
Coastal Clinical Research’s headquarters is housed in a modern 7,800 square foot facility located on Springhill Medical Center’s campus. Centrally located in Mobile and right off Interstate 65, CCR provides accessibility to patients in Baldwin County, Florida and Mississippi. For Sponsors and CROs, Mobile Regional Airport is less than 10 miles away.
Our facility allows multiple investigators to be onsite simultaneously with two separate clinic areas, each with four exam rooms. Our locked, temperature controlled drug room is equipped with three large refrigerators, a -20 °C freezer, wall-to-wall storage shelves and two narcotics cabinets. The temperatures of the refrigerators, freezers and the drug room are monitored and recorded at all times by a system called Temperature Guard. Additional space includes two ICF rooms, four monitoring offices, a large conference room, a patient lounge for extended or overnight stays, a locked chart room, and on-site short-term storage with additional long-term storage at a local off-site facility.
For CCR, recruitment begins at feasibility stage where we assess as a team, study feasibility and whether our patient population would support the indication and trial. This allows us to have a list of potential patients prior to being awarded. Our pre awarded recruitment strategies include:
Once a study is awarded, our team creates a recruitment plan based on prior advertising/recruitment metrics. We utilize a CTMS called Clinical Conductor to track study recruitment efforts managed by our two patient recruitment specialists. We collaborate with a local marketing firm to ensure we secure the best media buys and stay up to date on latest advertising trends. Our post awarded recruitment strategies include:
Tour the clinical trial facility online to get a better idea of what you can expect to see during at our facility.View Facility Tour
To date, Coastal Clinical Research, Inc. has conducted over 600 industry-sponsored clinical trials.View Therapeutic Areas