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Guide for Sponsors and CROs

Let’s change the world together. We look forward to working with you.

Clinical Research Associates is dedicated to advancing medicine that saves and improves lives through clinical trials. We conduct high quality, cutting edge, ethical clinical trials that provide sponsors with accurate, timely data in order to develop medicine that allows people to live longer and healthier lives. We have administered more than 650 studies in dozens of therapeutic areas, and prioritize sustaining relationships with partnering sponsors, CROs, and patients. We are dedicated to enrolling eligible volunteers from all backgrounds, and we treat all patients, clients, and staff with dignity and respect.

Our vast experience, ability to rapidly enroll diverse clinical trial participants, dedication to accurate and timely record keeping, and commitment to the highest quality research as an investigative research center merit your consideration.

CRA’s leadership team, including its medical director, CEO, data manager, and compliance officer have more than 80 years of collective experience administering clinical trials. We understand the time-sensitive nature in which sponsors must meet their goals, and we have the capability to execute timely requests. Our full time staff of investigators, coordinators, data managers, regulatory staff, leadership, and other support groups provide sponsors with real-time information throughout the entire research process, including: feasibility, site evaluation, investigator selection, study initiation, enrollment, monitoring visits, quality assurance, data entry, and study close.

Clinical Research Associates helps advance medicine that saves and improves lives by conducting cutting edge, high quality, ethical clinical trials that provide sponsors with accurate, timely data. We are dedicated to enrolling eligible volunteers from all backgrounds, and we treat all patients, clients, and staff with dignity and respect.

Clinical Research Associates is a multi-specialty center with experience in a wide range of diseases and conditions, including the following. If you don’t see something you need, just ask. After 30 years in business, we likely can help you.

 

Clinical Research Associates is located at 1500 Church St in downtown Nashville, within 10 minutes from Vanderbilt University, Fisk University, Belmont University, Tennessee State University and Meharry Medical College. CRA is easily accessible via nearby interstate exits and local transit and provides ample parking.

We also operate a converted RV that functions as a mobile exam room.

CRA maintains partnerships with local labs to assist in blood work and other processes that require capabilities outside of our facilities.

Click here for a full list of CRA’s facilities and capabilities.

Clinical Research Associates maintains and renews all certifications needed to administer clinical trials in the United States and Tennessee. We have two full-time staff members dedicated to ensuring compliance in all trials and keeping certifications current.

Each employee at CRA is asked to complete training in Good Clinical Practices (GCP) Training before beginning work at the firm.

CRA has a Certificate of Provider-Performed Microscopy Procedures authorized from the Centers For Medicare & Medicaid Services and the Clinical Laboratory Improvement Amendments otherwise know as CLIA.

We understand that timely and accurate data collection and reporting is one of the most critical aspects of administering clinical trials. CRA was named as one of the top global firms in accuracy and timeliness in a recent COVID-19 vaccine study, when better, faster data entry would save lives.

Clinical Research Associates is over-prepared to enroll diverse clinical trial volunteers on a rapid and continual basis. We utilize systematic recruitment and enrollment strategies that are based on experience, historic enrollment metrics, local community needs and interests, current health and medical trends, referral trends, and multi-media effectiveness.

Study recruitment is constantly ongoing and growing because our patients are more than just trial participants: they are part of a community. We regularly communicate with them through email, and social channels to raise awareness about current and future clinical studies. We utilize the time from study feasibility to site initiation to maximize recruitment success by building awareness in our community as early as possible.

Every patient has a different journey to joining a clinical study, and it’s our job to make sure that the patient’s journey is as smooth and easy as possible. This is a team approach, in combination with our marketing department, recruitment specialists, clinical coordinators, and medical director so that each team member is aware of the study requirements for each patient. We create custom campaigns for each study, and measure our success based on how quickly we are able to complete enrollment with a diverse group of patients. Our ongoing pre-study efforts and multi-strategic approach minimizes this unpredictability and provides value to Sponsors and CROs.

CRA is centrally located in a diverse city known for its universities and health care industry, along with dense urban areas and suburban sprawl, we are able to quickly reach a wide audience. We also maintain an extensive database of more than 45,000 prospective and past patients, which includes healthy volunteers and special patient populations.

Patient Diversity:
CRA is dedicated to conducting clinical trials with diverse patient populations that represent all of Nashville’s communities. We maintain partnerships with community organizations capable of reaching diverse audiences, and continuously co-host outreach and education events to spread awareness of clinical trial opportunities. These organizations include:

The Mayor’s Office of Neighborhoods and Community Engagement
      Meharry Medical College, an HBCU founded in 1876
The Hispanic Family Foundation and Plaza Mariachi
The Kurdish Professionals
The American Muslim Advisory Council
Futuro
Metro Nashville Public Schools STEAM Experiential Learning

In addition to developing partnerships, we prioritize cultural sensitivity and continuously work to ensure that each patient feels welcome, safe, and like an integral part of the research process. Read more about our diversity outreach here.

We also work with  The Nashville Metro Health Department to educate the community and translate recruitment materials to ease the enrollment process for non-English speakers. We maintain a fluent Spanish-speaker on staff as a clinical coordinator as well.

Nashville Population Demographics:

Nashville Census Data QuickFacts:
Total Population: 670,820
White, alone: 63.50%
Black or African American, alone: 27.60%
Hispanic or Latino: 10.50%
Asian, alone: 3.7%

CRA has a customer service mindset because we understand that patients and volunteers must choose to spend their time with us. We therefore work hard to ensure that the patient journey is as smooth and positive as possible, so that all feel welcome, taken care of, and helpful in the research process. Patients who have positive experiences are more likely to return for other research projects, encourage their friends and families to take part in research, and feel safe taking medicine.

Our successful patient retention strategy includes careful considerations before a patient makes the final decision to enroll. Our investigators and coordinators invest private time with them to discuss the the Informed Consent, and assess whether the particular volunteer is a good candidate for the study based on their health conditions and ability to commit time. Many factors, such as personal issues, the volunteer’s work requirements and pressures, future travel arrangements, logistical obstacles, perceived reliability, general interest and motivation, also weigh into the decision. Our investigators and recruiters are encouraged to exercise their discretion to make sure that each patient is a good fit for the study at hand.

Patient retention is just as important as initial recruitment. This means that once a patient has enrolled in a study, we continue to prioritize their needs, questions, and conditions so that they have a positive experience, beginning from when they first express interest in the study and persisting through their last visit.

We also compensate qualified participants appropriately for their time and travel expenses with a nominal fee per visit based on IRB recommendations.