Expert monitoring services in HIV, TB, CVS, Endocrinology Neurology and RWE clinical trials, tailored to each phase of your study. Investigator-driven trial support: - review Investigator Site File (ISF) to ensure completeness, accuracy and Inspection-readiness; - Streamline the process for regulatory submission up to approval; - Support with site source documentation review and alignment with site process and protocol requirements.
The Clinical trial site Setup and Staff Training service we offer is designed to facilitate the seamless establishment of trial sites and to empower staff with the knowledge and tools needed to conduct trials efficiently. Special focus on local requirements for research sites while adhering to ICH GCP guidelines for each clinical trial facility.
With our Quality Management service, you can streamline your operations, minimize time wastage, and consistently deliver trial data and services that exceed customer expectations. Ensuring compliance and high standards through quality management, quality control, and quality assurance processes.
Our Inspection and Audit Support service provides comprehensive assistance and guidance to ensure that the research site is fully compliant with local and international regulatory requirements and industry standards. Pre-inspection readiness training with mock inspection if required; Post-inspection support that includes: - Review of observation responses prior to submission; - adherence to inspection and audit response timelines; - Corrective Action and Preventative Action support to resolution.
Mentorship to clinical research personnel; Expertise provision on a needs-basis to clinical researchers; Tailor-made training per risk indicator; Grant-application process facilitation.