About
A reading tool for people who have to send the protocol
RWE Readiness Checker is published by The Art of Service. It exists because the expensive mistakes in a real-world evidence submission are usually visible in the outline long before the data is analysed: a plan deferred, a control matched on two variables, an agreement still in negotiation, a source record nobody has the right to inspect.
Who publishes it
The Art of Service Pty Ltd, founded by Gerard Blokdyk, publishes reference tools that read a published source and cite it so a buyer can check the line. This product follows the same pattern: one recorded source for the checks, held frameworks for the legal basis, and a visible link for every claim.
Who it is for
Regulatory affairs, epidemiology, medical affairs, biostatistics and clinical operations teams preparing a real-world evidence study for a pre-submission meeting or a filing. It is also for the consultants and CRO teams who review those outlines before they go out.
What it is not
It is not a law firm, a regulatory consultant, a certification body or a statistical reviewer. It does not write the protocol, decide the design or predict an agency decision. A finding is a reading of the text you pasted.
Contact
support@theartofservice.com. We answer questions about the product, the source and the reading. We do not give regulatory advice.
The name in public. Gerard Blokdyk is the founder and the name on the record. The Art of Service is the publisher. The contact address on every page is support@theartofservice.com.
Independence. Not affiliated with, endorsed by or approved by the US Food and Drug Administration, the International Council for Harmonisation, the European Commission, the European Medicines Agency, the UK Information Commissioner's Office, the Australian Government, the National Health and Medical Research Council or the Office of the Australian Information Commissioner. FDA Watch is an independent programme; this product is not affiliated with it.