redaction review

redaction and EMA Policy 70

PleaseReview allows for the redaction and redaction review of PDF documents. Whilst here we explain how this can help a specific business need, the redaction capabilities can also be applied to all other organizations experiencing challenges in this area.

PleaseReview, already widely used by Life Science organizations, now assists them in complying with the European Medicines Agency (EMA) Transparency Policy 70 on the publication of clinical data.

Published documentation must now be redacted to remove Personal Private Data (PPD) and Personally Identifiable Data (PID) and may also be redacted to remove some Commercially Confidential Data (CCI). In addition, a Justification Table must be provided to the EMA for each CCI redaction.

As a result, Life Science companies submitting to the EMA have a short amount of time to redact thousands of documents.

PleaseReview makes the delivery of PPD, PID and CCI redacted documents far easier.

Key benefits

PleaseReview can identify areas ‘marked for redaction’ in a PDF file. These can be commented upon, discussed and approved or rejected. Areas missed can be identified.
Review participants can propose redactions and see redactions proposed by others in the review.

Shortly, PleaseReview will also offer redaction categorization (i.e. for PPD, PID & CCI) offering differing properties including color and overlay text.
PDF documents can be downloaded with accepted (and open) redactions applied. No copy and pasting required.

Multiple teams can work in parallel and independently from each other on the document – results can then be consolidated into the master review. This can be useful, for example, if one team works on PID/PPD redaction whilst another works on CCI redaction.

A special justification report can be produced and be used as the basis for the CCI Justification Table, minimizing manual work.
All redaction activity is capture and can be reported on.

For a more detailed understanding, why not watch our brief movie reviewing and redacting PDF documents.