CRA Capabilities

Our team works with sponsor, network, and trial leadership to plan scheduling and logistics for virtual and in-person meetings, facilitate communication, provide documentation, keep records, and support manuscript development and tracking.

Our team trains and provides support for clinical site staff, facilitates communication, develops and implements recruitment and retention strategies, and incorporates protocol amendments. We also work with biorepositories, labs, and imaging reading centers to ensure protocol compliance and quality assurance. Site monitors conduct site initiation, intermittent monitoring, and trial close-out visits to ensure compliance with protocol, participant safety, and data quality.

Our scientific writer and operations staff assist with the development of grant proposals, trial protocols, manuals of operations, investigator brochures, and other documentation. We also help to identify clinical sites, and execute site subcontracts, budgets, or other contractual agreements in a timely manner.

We have dedicated personnel to coordinate contracts across institutional offices and push legal documents over the finish line. Our services include the development, review, and negotiation of master services, clinical trial, data use, and data confidentiality agreements, as well as all supporting documents in collaboration with UNC procurement offices and the Office of Sponsored Programs.

Within the CRA and through our established partnerships, we offer 21 CFR Part 11 compliant data capture, accrual tracking, trial master file data management, clinical data, and program management systems and support. Our team of data management experts develop case report forms and create site performance reports and dashboards, as well as reports for sponsors and network leadership.

The CRA has dedicated resources from the UNC SOM Finance & Research Support Team (FiRST) to provide comprehensive financial services from strategy to execution. This includes managing budgets, ensuring compliance with financial regulations, and optimizing financial processes for large-scale clinical trials that often involve multiple funding sources, intricate financial reporting requirements, and the need for strategic financial planning.

The CRA partners with proven Investigational Drug Services (IDS) entities to manage the formulation, labeling, packaging, and dispensing of investigational drugs and placebos used in clinical trials. We ensure compliance with regulatory standards and protocols, including inventory tracking, shipping, storage, and dispensing.

The CRA’s Medical Affairs team designs protocols, interprets data, and communicates with stakeholders to ensure the scientific integrity and strategic alignment of clinical trials.

The CRA has program managers who are consistent throughout the entirety of the trial and work directly with trial investigators as the administrator for the planning, execution, and coordination of all trial activities.

The CRA has regulatory personnel who provide strategic guidance for FDA and single IRB processes. This team coordinates FDA and single IRB submissions and provides ongoing support to ensure compliance through the life of the protocol.

The CRA has dedicated technology specialists who have expertise in clinical trial apps, management software, and reporting dashboards used by both academia and industry. Our team provides documentation and training to sites and other users and is available for direct support.