Sponsors / CRO

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Sponsors / CRO

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.

What We Offer

CCR Qualifications

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.

  • Initial regulatory completed within 72 hours of receipt
  • Contract and budget turnaround time within 48 hours of receipt
  • CCR’s standard operating procedure requires a 48 hour timeframe for data entry and query resolutions
  • Utilizes Central IRBs
  • Customized recruitment plan and patient retention program implemented for each study
  • Quality assurance program

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.

Facility

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.

Patient Recruitment

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:

 
  • Research site database: CCR’s growing database is our most successful method used in recruiting volunteers. Our database consists of over 22,000 people who have either been a prior study volunteer or expressed interest in a study. Our database is managed through a Clinical Trial Management System (CTMS) called Clinical Conductor. The database queries demographics, medical history and medications which provide more accurate answers for feasibility assessments and allow us to pre identify volunteers prior to being awarded.
  • Local community events: CCR’s team participates in many community events throughout the year to spread research awareness in our community, continue building our database and give back to our area. Community events include: health fairs, sponsorships, educational seminars and other charitable events throughout the year.
  • Quarterly newsletters: To maintain communication with 22,000 volunteers throughout the year, we create a quarterly newsletter that is mailed to our database. The newsletter provides information on newly awarded and upcoming studies and allows volunteers the opportunity to learn more about our investigators, staff and research in general.
 

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:

 
  • Local media advertising: The two most successful advertising methods are TV and social media. Additional methods used are radio, print and direct mail.
  • Website: CCR’s website provides the opportunity for patients to apply online for the research study of interest. All information collected from this online application is sent to and maintained in the secure inbox of one of our two patient recruiter specialists.
  • Investigator referrals: Our investigators are contracted per study and have a separate private practice not affiliated with CCR. Our investigators will identify potential patients through each of their individual private practices.
  • Schools: CCR is also able to draw from a significant young adult population in Mobile due to several universities and colleges being located in the area. The University of South Alabama located nearby boost an enrollment of nearly 14,000 students.
  • Word of mouth: We find that once someone participates in a study, the word quickly spreads throughout their family and friends of their exceptional experience at CCR.
Online Tour Clinical Trial Facility

Online Tour

Tour the clinical trial facility online to get a better idea of what you can expect to see during at our facility.

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Therapeutic Areas

Therapeutic Areas

To date, Coastal Clinical Research, Inc. has conducted over 600 industry-sponsored clinical trials.

View Therapeutic Areas

Industry Partners

  • Advancing the future of human health through science.
  • Leading Growth Pharma
  • Amgen improve the lives of those who suffer from disease.
  • Astellas Pharma US, Inc.
  • Bayer HealthCare
  • BioSante Pharmaceuticals, Inc
  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • Passion for innovation. Compassion for the patients.
  • Depomed, Inc.
  • Forging the Future of Dermatology
  • Dow Pharma
  • G&W Laboratories, Inc.
  • Medical solutions for the skin.
  • Help people to do more, feel better, live longer.
  • Lipocine
  • Luitpold Pharmaceuticals, Inc.
  • Maruho Co Ltd.
  • Medimmune.
  • Our mission is to care and cure.
  • Driving change to defeat diabetes and other serious chronic conditions.
  • Palatin Technologies, Inc
  • Better Vaccines to Better the World.
  • Quality Affordable Healthcare Products
  • Applying science to discover therapies.
  • Promius Pharma is a new face in the dermatology community.
  • Specializes in vaccine development and protein production..
  • Advancing the medical care of patients with quality pharmaceutical products.
  • Science to medicine
  • Drugs to treat hormonal and reproductive system disorders.
  • Immunization saves more than 3 million lives every year.
  • Takeda Pharmaceutical Company Limited
  • Taro Pharmaceuticals, USA, Inc.
  • Synergy that Results in Better Healthcare.
  • TherapeuticsMD

About CCR

Our mission is to provide our community with the most novel and highest quality research medicines while remaining an efficient and dedicated leader in the pharmaceutical research industry.

Community

Coastal Clinical Research is proud to support our local area chapters of the following organizations:

Office Hours

  • Sunday Closed
  • Monday 6:30 a.m. - 3:00 p.m.
  • Tuesday 6:30 a.m. - 4:00 p.m.
  • Wednesday 6:30 a.m. - 4:00 p.m.
  • Thursday 6:30 a.m. - 4:00 p.m.
  • Friday 6:30 a.m. - 1:00 p.m.
  • Saturday Closed