Last Mile, Wet Ink Signature Coordination
Global CROs and sponsors, large and small, trust us to manage their last-mile wet ink
signature coordination, regional formatting, and delivery.
We can help you bridge the fragmented world regulatory landscape. Done on a per-unit basis –
no subscription and no implementation required.
The Grey Areas of Signature Requirements
The introduction of the 2016 European Parliament and eIDAS legal framework changed signature requirements for the EU. This legal framework, with its remaining grey areas, means wet ink signatures are still required or preferred in many EU countries.
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eIDAS recognizes three trust levels for eSignatures with only the highest level, Qualified Electronic Signatures (QES), being the legal equivalent of a traditional wet ink signature. QES additionally require specialised hardware & software and must be registered with a third-party Qualified Trust Service Provider (QTSP), potentially defeating any increased efficiency over ink.
The CTIS (Clinical Trials Information System) portal, launched in 2022, requires all new trials to use its system and all ongoing trials to transition to the portal by January 2025.
Currently, the CTIS is largely thought to be completely digital but in their training, defer to member states:
“The method used to document consent should follow national legislation with regard to e.g. acceptability of electronic signatures… and in some countries ‘wet ink’ signatures will be required.” ¹
Whether a legal requirement in the member state, a cost vs benefit choice, or simply a preferred format for signatures, docs24 has you covered.
The Regulatory Process with docs24
Getting your signed documents to their destination is easy with docs24.
Schedule a pickup or drop off of the originals and we’ll handle the rest.
docs24 prepares the files according to your instructions, collating them with any required printed documents, and creating an electronic version on CD-ROM if requested.
The compiled documents are shipped and the tracking number is provided to you upon dispatch.
We challenge the status quo with our ethos of simplification through innovation. Our tech-led approach to clinical document solutions allows CROs and Sponsors to get back to doing what they do best.
