Quality - Africa Research Gate

Quality and Compliance

At Africa Research Gate, Quality and Compliance form the cornerstone of our commitment to excellence in clinical research across the continent. Our dedication to ensuring the highest standards of quality and compliance underscores every aspect of our operations, from protocol development to trial execution and beyond. With a steadfast focus on adhering to regulatory requirements and industry best practices, we strive to maintain integrity, transparency, and accountability in all our endeavors. By upholding stringent quality standards and robust compliance protocols, we aim to instill confidence among stakeholders, foster innovation, and drive impactful advancements in healthcare throughout Africa.

A unique, industry-leading quality oversight model

In-house clinical data, quality assurance, regulatory, and risk management teams

All sites and studies supported by centralized, industry-leading quality oversight expert

Unique model reinforces compliance and ensures timely, accurate data delivery

48-hour data entry target; query resolution within 48 hours of generation

Quality Control

Conducts comprehensive reviews of all source documents for the first five participants in each study to detect early potential errors, inconsistencies, deviations, or clarifications needed in the protocol.
Monitors specific participants closely throughout the study as key indicators of protocol compliance.
Employs a risk-based quality control approach for assessing the source documents of remaining participants.
Examines informed consents, eligibility screenings, and adherence to ACLOA-C standards.
Performs targeted reviews to identify any missing concomitant medications, adverse events/serious adverse events, and ensures primary endpoints are executed properly (e.g., diary check documentation, safety call documentation, primary endpoint lab results acquisition).
Reviews all visitations made by newly onboarded Clinical Research Coordinators (CRCs) during their initial 90 days.

Quality Assurance

Prioritizes participant safety and data integrity in all operations.
Maintains strict adherence to study protocols and relevant guidelines.
Offers pre-enrollment start-up training for site staff to minimize protocol deviations and prepare sites effectively.
Conducts thorough document reviews at critical study junctures, verifies EDC data against source documents for specific data points, and examines monitoring visit follow-up communications.
Identifies trends in quality management, informs training strategies, and facilitates swift resolution of pending tasks.
Complies with all local, state, and federal regulations.
Prepares for audits to ensure readiness for reviews by regulatory or oversight bodies, including targeted audit support and site preparation.
Prepares for audits to ensure readiness for reviews by regulatory or oversight bodies, including targeted audit support and site preparation.
Comprises experienced Clinical Research Associates (CRAs), monitors, and operations managers with expertise in monitoring, ICH GCP Guidance, and various therapeutic domains.

Clinical Data

Performs cross-checks between EDC and source to ensure document standardization and integrity, fulfilling clinical trial data quality needs.
Comprises a diverse team of an investigator, Clinical Research Associates (CRAs), licensed medical professionals, regulatory experts, Quality Assurance (QA) specialists, and study coordinators.
Develops and assesses source documents, gathers study data, and examines participant visit timetables.
Works in conjunction with various departments for comprehensive project management, risk evaluation, study initiation, ongoing maintenance, and personnel training.

Regulatory

Facilitates rapid initiation of studies and daily site operations.
Features both on-site and remote experts managing essential clinical trial documents, both digitally and in paper format.
Regularly dispatches team members to sites for training and to confirm compliance with Standard Operating Procedures (SOPs).
Assists in comprehensive audit preparation, with a specialized team helping to manage FDA audits to minimize impact on site functionality and patient services.