Quality assurance

Procedures that hold up under inspection.

From free checklists to audits and a fractional quality lead, built for compliance with ICH E6(R3) and the regulations behind it.

Template Portal · subscription

The full sponsor template library.

Plans, SOPs, logs and registers in Word and Excel, unbranded so they enter your QMS under your own document control. The Gray Letter is included.

Annual
$2,400 a year
  • The full library and every new version
  • The Gray Letter for your team
  • Up to 5 named users
See the Template Portal
Free tools
$0
  • Checklists and guides for study managers, CRAs and CRCs
  • The full standards library
  • Work email required
Register free

Monthly plans are also available. Browse the library or sign in.

Services

Quality work, scoped to your risk.

Each is scoped and estimated after a short call.

Refined templates

Any portal template, or your own, reviewed against how your team works, tailored to your roles and systems, and delivered ready to approve.

Book a scoping call

Desk audit

Your documents checked against ICH E6(R3). For when you need to know your procedures are adequate.

Book a scoping call

Interactive audit

How a partner follows its procedures, checked with the people who do the work. Remote by video, or on site where the work happens for high risk or an expected inspection.

Book a scoping call

Fractional clinical quality

A monthly block of senior quality hours, with priority access, for teams without a full-time quality lead.

Book a scoping call
Next step

Scope your quality work.

A 30-minute call to understand your study, agree the scope and set a fixed estimate.

Book a scoping call
Free resources