Service
Clinical Research & Operations Support
Operational and documentation support that keeps studies organised, traceable and inspection-aware.
Overview
Well-run studies are built on clear plans, current documentation and reliable tracking. We provide operational support that sits alongside your clinical team and keeps the moving parts organised.
Our focus is on the supporting work that is easy to under-resource: trackers, plans, document control and coordination, delivered with a consistent quality mindset.
Standards & frameworks we work within
- ICH E6 (GCP) principles
- ICH E8 general considerations
- CDSCO New Drugs and Clinical Trials Rules, 2019
- ICMR ethical guidelines
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Study start-up documentation support and tracking
- Trial master file organisation and completeness checks
- Study plan and manual drafting support
- Operational metrics and status reporting
- Protocol and data requirement review support
Typical deliverables
- Study trackers and status reports
- TMF index and completeness reviews
- Draft study plans and manuals
- Meeting minutes and action logs
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss clinical research & operations support
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.