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 sponsor is accountable for the conduct of its trial, whether the work is done in-house or by a CRO. That accountability has to live somewhere, and in practice it lives in your procedures.
Most early-stage sponsors arrive at this the same way: a partner asks for the SOP list, an investor asks about quality, or an inspection is scheduled. Writing a GCP-compliant suite from scratch at that point takes months you do not have, and produces documents nobody follows because nobody was involved in writing them.
The alternative is not buying a generic library and hoping. It is starting from procedures that are already aligned to ICH E6(R3) and shaping them around how your team actually works.
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.
The package covers sponsor obligations under ICH E6(R3): quality management and document control, training and competency, risk and quality management, service provider selection and CRO governance, regulatory and ethics submissions, investigator and site management, the trial master file and essential documents, monitoring, pharmacovigilance and safety, data management and integrity, deviations and CAPA, and audit and inspection readiness.
Templates are aligned to ICH E6(R3), FDA clinical trial regulations (21 CFR Parts 50, 56 and 312) and the EU Clinical Trial Regulation, and can be adapted for other jurisdictions — so a sponsor running across regions has one system rather than three that disagree.
Delivery is phased. Core procedures come first so you can start using them, with the rest following, and each phase includes a round of consolidated review. Everything arrives as version-controlled, editable Word files with the forms, templates and checklists that go with them. They are yours to maintain.
Bought alongside this, not instead of it.
Start with a gap analysis
Already have SOPs? We review what you have against current GCP expectations first and give you a prioritised list, so you only pay to change what needs changing. Half the fee comes off the package if you go ahead.
Fractional QA support
A QA consultant reviews and signs off SOPs on your behalf, for sponsors without a quality function of their own.
Annual review and update
We track regulatory change and keep your suite current, so the set does not quietly age into non-compliance.
Additional customisation
Further tailoring beyond the customisation included in the package, charged by the hour.
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.
Do our existing SOPs need updating for E6(R3)?
Usually yes, but rarely a rewrite. Most pre-R3 procedures are structurally sound and need reworking around risk-based quality management, sponsor oversight of delegated activities, and data governance. A gap assessment against E6(R3) will tell you which procedures need revision and which can stand as they are.
Which activities can we outsource to a CRO, and which stay with us?
Almost any trial activity can be delegated, but accountability cannot. The sponsor remains responsible for the conduct of the trial regardless of who performs the work, so you need procedures governing how vendors are selected, managed and overseen even when the operational work sits entirely elsewhere.
Ready to get trial-ready?
Tell us where you are — we'll handle the rest.