EDC and CTMS integration
Trial sites, subjects and visits kept consistent between data capture and trial management.
Industry focus
Life sciences clinical data
We keep trial data complete, attributable and ready for inspection.
Clinical trials spread data across sites, sponsors and safety teams. We integrate EDC and CTMS systems, apply GxP data integrity controls, and connect pharmacovigilance feeds so safety signals are not lost between systems.
Trials and safety reporting follow MOHAP and the emirate health authorities in the UAE, and SFDA requirements in Saudi Arabia.
What we deliver
GxP data integrity
Audit trails, system validation and access controls of the kind inspectors look for.
Pharmacovigilance feeds
Adverse-event data passed between systems with reconciliation, so no report is dropped.
What to have in place first
Clinical governance and privacy officers review every change, so it helps to settle these points first.
- The trials and sites in scope are listed.
- Validation expectations are agreed with quality assurance.
- Safety database owners are named.
Talk to us about life sciences clinical data
Tell us about your current systems, the compliance themes you cannot compromise on and your timeline. We will come back with a phased plan, a staffing model and a risk register.