- SOPs, Templates, Style guides, Rule books, and so on .. Leading to lesser time for “Science”
- Documents and Data live in different worlds
- “Soft knowledge” not captured (all out of door, when people leave)
- QC and Oversight, drain on time
- Manual repetitive tasks a serious loss of productivity
| Persona | Motivation & Frustration |
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Head / Manager |
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Medical Writer |
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- Level 1: Apply Natural Language Processing (NLP) to capture any/all data of interest
- Level 2: Apply special logic on Tables/Images mining for additional/secondary data
- Apply business rules to map to ICH or Transcelerate or YOUR data models
- Align industry standard CV/Libraries (like CDISC)
- Apply customer specific rules or dictionaries
- Create base Clinical master content, Templates
- Author Clinical documents (Protocols, IB, CSR and others) either from Templates or Our Automated Authoring functionality. Or use MS Word
- Embed Clinical data (that’s Digitized in our tool or by linking any of your Source systems directly) in the documents
- Without the need of Templates, Style Guides, Rule books download “Fully Formatted” or “submission-ready” documents for various countries, in seconds
- Eliminate or Minimize QC & Reviews
- Add your “custom” business processes, workflows, rules, documents to extend the Automation further
Word is undoubtedly the world’s most popular word processing program.
You’ve got your document formatted exactly to specifications: titles are properly bolded, headers/footers with margins all well aligned, page/section breaks in place, bullets sit in perfect lines. Then you insert just one troublesome table or footnote — everything is shot. Goodbye beautiful formatting; goodbye well-arranged page.
What seems to be a ‘simple’ edit has added 18 minutes of formatting time. It doesn’t have to be like this.
REGai automates document formatting and most documents are auto-formatted in SECONDS. With 300+ extensive rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. You are in control as all this is done using a simpler user interface that’s cloud-based (or can be run as batch connecting to your EDMS or RIM systems).
ROI / Savings: 70% and above compared to your current manual costs. Guaranteed!
Functionality
Formatting Rules: Standard Out-of-box rules for most country requirements like FDA, EU, and other regions +you can use any custom formatting rules from our vast library on DOC or PDF (Layout, Style, Header/Footer, Tables, TOC, Bookmarks, Hyperlinks, and more).
Mode: You can do Real-time or run as Batch.
File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources.
Download: Source/Output files and Formatting Report, Output files are available as ZIP or have REGai upload to your EDMS or your servers.
Access: Cloud (hosted on Private Cloud in USA/Germany) For high-volume work, on-prem available.
QC is important. What makes this process a big drain of time (and $$) are too many checks (some important and some not-so) and manual steps.
In most companies QC is a Manual process. Whether you do in house, outsource or offshore, Manual QC is NOT acceptable when technology and options are available. Even if you outsource some of these, you are still spending time as part of “Oversight” that costs you time.
Several research articles and surveys point that QC takes 10 to 30% of overall time in Document life cycle. Imagine if the author or a senior resource is doing this task, you can do the math based on how many documents are being QCed per month. You can stop or minimize this $$ drain and free up time for your resources to do more value add tasks. Not just $$, but Cycle time can be improved drastically for faster turn-around.
REGai Automates QC. With 400+ QC checks built-in, you pick what QC to apply to which document. You are in control as all this is done using a simpler user interface that’s cloud-based.
ROI / Savings: 50% and above compared to your current manual costs. Guaranteed!
Functionality
Checks: Standard Out-of-box checks for FDA, EU, and other regions + you can use any custom checks from our vast library to comply/meet your Rule books and current QC checklists. Currently we have pre-defined packages for Clinical documents (like CSR), Labeling (USPI/SPC), and others.
QC + Fix: Opt to fix the way you want when an error is found while running QC checks. Saves lot of time instead of pushing back to authors or you open documents and fix manually
File Options: PDF, Word
Mode: Real-time or Batch (for large size files, tool can directly push/pull from your current EDMS).
File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources.
Download: Along with Source and Output file (if you opt for fix), detailed QC report included which you can file for compliance purposes (no need of additional manual QC reports).
Access: Cloud (hosted on Private Cloud in USA/Germany) For high-volume projects, on-prem available.