Quality & compliance
Built to withstand inspection
Every ACRS study is conducted to ICH-GCP and Indian regulatory requirements, with quality built in from protocol to database lock.
Standard operating procedures
Documented SOPs govern how we plan, conduct, monitor and report studies, and we help sites set up their own.
Data integrity
A 21 CFR Part 11 compliant data management system, and source documentation to ALCOA principles: attributable, legible, contemporaneous, original and accurate.
Risk-based monitoring
Monitoring plans that focus effort on the data and processes that matter most for patient safety and data reliability.
QA and audits
Quality assurance from study inception to database lock, including GCP audits with CAPA follow-up.
Trained people
Regular ICH-GCP and role-specific training for our CRAs, coordinators and project staff, delivered by our own academy.
Confidentiality
Sponsor information is handled under NDA, and participant data is protected in line with applicable data protection law.
Credentials
Certifications and inspection history
Sponsors can request our quality documentation, SOP index and audit history as part of vendor qualification.
Request quality documentation →Planning a study?
Tell us about your protocol, timelines and therapeutic area, and we will suggest how ACRS can support it.