Clinical Safety, Built for GI
Safety doesn’t happen in a silo. Our safety team coordinates closely with medical monitoring, site management, and clinical data science to ensure cases are complete and decisions are swift.
We own day-to-day safety work including:
Safety management plan
A study-specific plan defining roles, responsibilities, case processing timelines, and safety reporting requirements
Case intake and processing
Capture of adverse events (AEs) and serious AEs (SAEs), MedDRA coding, causality assessment, and follow-through to closure
Expedited safety reporting
Submission of suspected unexpected serious adverse reactions (SUSARs) and other reportable safety information to investigators, ethics committees, and agencies on time
Aggregate reports
Preparation of development safety update reports (DSURs) and periodic summaries
Literature and signals
Targeted surveillance, trend reviews, and documented signal evaluations with clear escalation
Data and Safety Monitoring Board (DSMB) Support
If a data and safety monitoring board (DSMB) or data monitoring committee (DMC) is required, we manage the logistics and documentation to ensure independence and compliance:
Charter development
Drafting the committee charter to define responsibilities and voting rules
Meeting management
Scheduling meetings, preparing blinded/unblinded data packs, and tracking follow-up items
Secure workflows
We use secure systems to protect blinding and document all decisions
Clinical Safety at Every Stage
With GI‑specific workflows, aligned teams, and clearly defined responsibilities, safety oversight stays consistent at every stage of your study. You get timely visibility, clean escalation routes, and a safety function that simply works the way your trial does.
