We support the creation of high-quality clinical documentation, from protocols and investigator brochures to clinical study reports (CSRs), patient narratives and submission dossiers. Our medical writers combine scientific understanding with regulatory precision to ensure clarity and compliance.

Our consultants assist with study start-up, site coordination, monitoring and trial management. We provide operational support to ensure timelines are met, trial execution is smooth and communication flows effectively between sponsors, sites and CROs.

We help design, implement and manage clinical databases that support clean, validated and submission-ready datasets. Our experts handle CRF design, data validation, query management and database lock activities, using industry-standard tools and methodologies.

We provide QA support across the clinical trial process. Including SOP development, audit preparation, CAPA tracking and vendor oversight. Our goal is to ensure trials are inspection-ready and aligned with GCP, ICH and sponsor requirements.

Our drug safety specialists manage pharmacovigilance activities including case processing, signal detection, literature review and safety report writing. We help you monitor and manage risk throughout the clinical lifecycle, ensuring patient safety and regulatory compliance.