Clinical trial SOPs, ready in days.
A complete, GCP-compliant set of standard operating procedures — built from proven templates, tailored to how you actually work, and implemented with you.
The challenge
Every clinical trial runs on SOPs, and inspectors will ask for them. Writing a compliant set from scratch can take months you don't have — and gaps or copy-paste procedures are exactly what regulators flag. Most first-time sponsors underestimate it until a deadline forces the issue.
What's included
A full GCP-compliant SOP library
The core procedures sponsors need — trial conduct, monitoring, safety reporting, document control, and archiving.
Tailored to your study
We adapt each procedure to your trial type, team, and vendors — not generic boilerplate.
Version control built in
Properly identified, versioned, and controlled, so your evidence trail holds up under inspection.
Training-ready
SOPs your team can actually follow, with clear owners and steps.
How it works
Start from proven templates
We begin with a battle-tested, GCP-aligned SOP set — so you're not staring at a blank page.
Customise to your trial
We tailor every procedure to your study, processes, and partners.
Implement with you
We roll them out, train your team, and make sure they stick.
Standard operating procedures (SOPs) are the documented, step-by-step instructions that keep a clinical trial consistent, compliant, and inspection-ready. They define how your team conducts the trial, monitors sites, reports safety events, manages data, controls documents, and oversees vendors.
For a sponsor, a robust SOP set isn't optional — it's the backbone of GCP compliance and the first thing a regulator asks to see. We give you a complete, proven library, tailored to your trial, and help you put it into practice.
Frequently asked questions
What SOPs does a clinical trial sponsor need?
At minimum, sponsors need SOPs covering trial oversight, monitoring, safety and adverse-event reporting, data management, document control and archiving, vendor oversight, and quality management. The exact set depends on your trial type and how much you outsource.
How long does it take to put SOPs in place?
From scratch it can take several months. Starting from proven templates and tailoring them, most sponsors can have a working, GCP-compliant SOP set in days to a few weeks.
Do I need my own SOPs if I use a CRO?
Usually yes. Even when a CRO runs operational activities, the sponsor keeps oversight responsibilities and needs SOPs governing how it selects, manages, and oversees vendors.
Ready to get trial-ready?
Tell us where you are — we'll handle the rest.