Acrobat for Life Sciences

Instead of collecting pen-and-ink signatures, life science organizations are looking to digital signatures to reduce the time, expense, and data inaccuracies that come from scanning and rekeying information.

The SAFE-BioPharma Association has developed a unified business, policy, and technical
model that defines digital signatures for the life science industry.

This cross-organizational standard reduces the time to market and cost of clinical trials by streamlining the way regulatory agencies, pharmaceutical companies, clinical research organizations manage and verify digital signatures.

SAFE has excellent support from many pharmaceutical companies and industry associations who already support the standard.

Adobe Acrobat and Reader 8 have been certified to comply with the SAFE standard.

However, before employing SAFE in Acrobat, some set-up and configuration is necessary.

My colleague Ed Chase has been actively involved in Adobe's support of SAFE and has written a guide to simplify using and deploying SAFE signatures.

Following, you'll find the guide which describes how to set up Adobe Acrobat and Adobe Reader to best support the technical and user interface requirements of the SAFE standard.

Acrobat Digital Signatures,SAFE Signature,PDF signing

Continue reading "Using and Deploying SAFE Digital Signatures in Acrobat 8" »

Posted by Rick Borstein at 01:01 PM | Permalink

acrobat beta testing,acrobat pre-release program,adobe beta

Since PDF has become the de facto format for regulatory filings, use of Adobe Acrobat is nearly ubiquitous across the pharmaceutical and medical device industry.

It is advantageous to know as much as you can about new software that will arrive in the months ahead. With that knowledge, you can plan your budget, anticipate training needs and investigate how the new product will fit into your existing infrastructure.

What new features will be in the next version of Acrobat?

I can't tell you here, but you may be able to find out yourself by signing up for Adobe's Pre-release Program.

Continue reading "What will be in the next version of Acrobat?" »

Posted by Rick Borstein at 02:22 AM | Permalink

Text to PDF Conversion,Acrobat Batch Processing,Batch Sequences

Not long ago, I heard from a large pharmaceutical company working on a new drug submission. As part of the process of testing the new compound, they had written over one thousand Visual Basic programs to process and organize data.

In communication with FDA staff, they learned that they would be required to submit the computer code for these programs for review by the agency.

As you might guess, the prospect of opening the code for each program individually in a word processor and converting to PDF was not appealing.

Was there a way to automate the process that would also allow control over fonts, layout and the version of PDF needed for submission?

Yes, this is possible using Acrobat 8 Professional.

Read on to learn about Batch Conversion of Text Files to PDF.

Continue reading "Batch Conversion of Text Files to PDF" »

Posted by Rick Borstein at 02:32 AM | Permalink | Comments (0)

Acrobat OCR,Acrobat Batch OCR,OCR,Searchable PDF

Paper— or the digitally scanned equivalent— is still a large component of regulatory filings for many pharmaceutical firms.

Note that the FDA encourages submission of PDF documents created from computer applications instead of scanned PDFs.

The FDA offers this guidance on the CDER site in a PDF document called Portable Document Format Specifications:

Avoid image based PDF files whenever possible. PDF documents created directly from an electronic source such as a word processing file provides many advantages over PDF documents created by scanning paper documents. Scanned documents are more difficult to read and do not allow the reviewer to search or copy and paste text for editing in other documents.

Unfortunately, paper is an unavoidable part of submissions for many firms.

In order to assist agency reviewers, it is a best practice to use Optical Character Recognition (OCR) to create a searchable PDF document from scanned originals.

Background: Making Paper Searchable

Most devices that scan to the PDF format produce an image-only PDF. An image-only PDF contains a picture of a page (scan) in a PDF wrapper— it does not contain searchable text.

Acrobat’s OCR (Optical Character Recognition) feature allows the addition of an invisible layer of searchable text to assist document reviewers:

Acrobat Standard can perform OCR on only one document at a time.

Acrobat Professional, however, can create Batch Sequences which offer OCR automation.

In this article, I offer step-by-step instructions to create a batch sequence that allows for the efficient processing of hundreds or thousands of documents.

Note that this article does not cover every aspect of the FDA's guidance for PDF creation, but I plan to address additional topics in the future.

Continue reading "Batch OCR using Acrobat Professional" »

Posted by Rick Borstein at 01:31 AM | Permalink | Comments (1)

FDA 1572 Forms,Converting 1572 forms

The U.S. Food and Drug Administration (FDA) provides Statement of Investigator forms—commonly known as 1572 forms— in downloadable PDF format.

Download the form from the FDA (Opens in a new window)

The FDA-supplied 1572 form is an XML-based form in the Acrobat 7 file format (PDF version 1.6). The date on the form indicates that it is valid through May 31, 2009.

XML-based files are convenient for data collection workflows and may be digitally signed using SAFE signatures.

However, for IND and NDA submissions, the FDA seems to insist on receiving Acrobat 5 (PDF 1.4) level files.

On the surface, it does seem that this is an example of the agency not following its own guidelines.

What should you do?

• Submit the forms in the same format supplied by the FDA?
• Convert the files to PDF 1.4?

In this article, I’ll discuss what I’m hearing from the various Pharma firms I work with and also suggest ways to convert these forms to Acrobat 5-level files.

Continue reading "FDA 1572 Forms: Convert or not?" »

Posted by Rick Borstein at 11:05 AM | Permalink | Comments (0)