TOOLS AND TEMPLATES
Decades of operational expertise, packaged so your team can be ready, willing and enabled. Processes, tools and templates for sponsors, CROs and sites.
Sound principles. Stronger execution.
START HERE — FREE
Score yourself against ICH E6(R3) and the workbook names the kit that closes each gap — so you buy what you are missing and nothing else. Free, and yours to keep whether you buy anything or not.
157 sponsor-facing expectations from Annex 1, scored against your current state. Flags the 32 requirements that are new since E6(R2) and names the kit that answers each one.
134 site-facing expectations scored against what your site does now. 50 are new in R3, and every row names the procedure that closes it.
Nothing phones home. The scoring stays in your file.
CHOOSE A TOPIC
Take one or take them all. Buy the single kit you need, or the complete set for less than the parts.
What the sponsor has to do, and the evidence that shows you did it. Grouped by the job.
The same guideline from the investigator site’s side, for the people that run the visits.
Decentralised elements and real-world data, for sponsor and site together. In build.
EVERY DOWNLOAD INCLUDES
Forms and templates ride along free. You pay for the procedure. Its worksheets, logs and registers come with it.
Editable source files. Word, Excel and PowerPoint.
Individual licence. Every study your own organisation runs. No seat counting, no renewal.
Practice licence on complete sets. For CROs, consultants and site networks deploying across more than one client organisation.
Download it again. Your account keeps the link.
Read Me First. Every set opens with a plain-English guide to deploying it.
HELP US PRIORITISE
Here is what is on the list. If the thing you need is missing, or you want to push one of these up the order, tell us on the contact form — there is a spot for it.
IF YOU WOULD RATHER NOT DIY
A kit gives you the documents. An engagement gives you an operator who owns the outcome. Same thinking either way.