Our Clinical Research Associates bring an SDR-first approach to every site visit — ensuring data quality, regulatory compliance and inspection readiness throughout your trial.
SDR methodology built into every monitoring visit from site set-up.
Centralised risk indicators driving targeted on-site activities.
ICH E6(R2) documentation standards maintained throughout.
CRAs based in Johannesburg with national and international reach.
Every visit is conducted to ICH E6(R2) standards, documented in real time, and followed up with a written monitoring visit report within agreed timelines.
SQV
Assessment of site facilities, staff, patient access and regulatory infrastructure to determine suitability for the study. Includes review of site CVs, SOPs and essential document readiness.
SIV
Comprehensive training of site staff on the protocol, CRF completion, ICF process, IMP handling, SAE reporting and source documentation requirements before first patient enrolment.
RMV
Ongoing source data verification, protocol compliance review, query management, IMP accountability, essential document review and subject safety monitoring throughout the active study.
Co-Mon
Accompaniment of sponsor or CRO monitors on site visits to provide local regulatory context, manage language and cultural requirements, and ensure quality of monitoring outputs.
RBM
Risk-based monitoring activities conducted remotely, including centralised data review, risk indicator analysis and targeted follow-up to complement on-site monitoring visits.
COV
Final site visit to confirm all study activities are complete, outstanding queries resolved, IMP returned or destroyed, and essential documents archived to regulatory standards.
Source data integrity is the foundation of every reliable clinical trial. Our SDR-first approach embeds data quality checks from the earliest stages of site setup.
We work with sites to establish compliant source documents before the first patient is screened — reducing downstream query volume and protecting data integrity from day one. Source document templates are reviewed against the protocol, CRF and applicable regulations before SIV.
Our CRAs conduct systematic source data review at every monitoring visit using protocol-specific checklists. SDR findings are documented in the monitoring visit report and fed into the central risk management system, enabling early detection of data quality trends.
SDR outputs drive centralised risk indicators, allowing the monitoring plan to adapt dynamically to site performance. High-risk data points trigger targeted on-site visits; low-risk sites benefit from reduced monitoring burden — all aligned with ICH E6(R2).
All monitoring activities are documented to SAHPRA and ICH standards. Sites managed by Alpha CR Solutions are prepared for sponsor audits and SAHPRA GCP inspections at any point in the study — not just at close-out.
A complete and contemporaneous Trial Master File is not just a regulatory requirement — it is the evidence of how your trial was conducted. We manage TMF compliance throughout.
Setup and maintenance of all essential documents at site level, including approvals, agreements, staff CVs, training logs, and all correspondence with regulatory and ethics authorities.
Periodic review of the Trial Master File against the essential documents list from ICH E6(R2) and the study-specific TMF plan, with gap analysis and remediation tracking.
At close-out, preparation of all site documents for archiving to regulatory standards, including the required retention periods under SAHPRA regulations and sponsor requirements.