Your solution to EMA Policy 0070
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Shadow™ is a leader in automating Data and Document De-Identification and Anonymization technology. Built from the ground up by the innovative teame at GenInvo, a team comprised of both life sciences and software development professionals committed to producing innovative and long-standing solutions that allow you to focus on innovative science and results.

Shadow™ alleviates the pain points of homegrown software utilities that often prove to be inefficient, difficult to maintain, and slow to match quickly evolving requirements.

Anonymization of documents has been particularly challenging for life sciences companies as they look to comply with EMA Policy 0070. Shadow™ has been developed to help our clients address these challenges now and into the future.

Shadow is a 21 CFR 11 and GDPR compliant solution to support global data sharing and deidentification requirements.

THE LATEST INDUSTRY BREAKTHROUGH

Data + Document
Anonymization

Shadow™ is a comprehensive solution to address the evolving landscape for data and/or document de-identification and anonymization

Anonymization
Reports

Reports to help drive, describe and monitor your anonymization project and the effectiveness of your teams.


Risk Analysis

Determine the risk for re-identification of your data before and after de-identification to ensure you meet required thresholds.


Data Utility

Evaluate the impact of your applied de-identification strategies to ensure consumers’ ability to reproduce analyses

Dynamic Strategy
Repository

Leverage the software’s “canned” (predefined) de-identification strategies for CDISC SDTM and ADaM along with those you develop to support your own data and document standards

Process
Workflows

Get right to work, or let Shadow™ guide you and your project team members through de-identification, review/approval and anonymization

Real-Time
Results

See the effects of your de-identification strategies as you apply them so that you can determine and tailor their effectiveness

Cutting Edge
Solution

Built from the ground up by the innovative time at GenInvo, a team comprised of both Life Sciences and software development professionals

Performance
Metrics

Evaluate precision/efficiency of strategy application and effectiveness of the de-ID teams/personnel

Full Features and Benefits List
of Shadow™

Shadow™ is a fully featured, EMA compliant solution

  • Data (and Document) De-Identification and Anonymization
  • Workflow component
  • Risk Analysis Tools: Ability to determine risk for re-identification
  • Tools to determine data utility after de-ID
  • Ability to generate Redaction Proposal
  • Ability to generate Anonymization Plan
  • Ability to generate Anonymization Report
 
  • Ability to store/Apply De-ID strategies in metadata repository at Global, TA, Compound, Study, and Project Levels
  • Ability to interactively Apply/Test Data and Doc Rules
  • Dual-frame before-n-after views of data and documents during de-ID process
  • Performance Metrics: evaluate precision/efficiency of strategy application and effectiveness of the de-ID teams/personnel
  • EMA Policy 0070 (Phase 1 and 2), Health Canada, France’s MR001-MR004, compliant

Contact Us

US Head Office

  • 1 Brickyard Drive
    Bloomington IL-61701

India Head Office

  • 6269/4, Nicholson Road, Ambala Cantt 133001 (Haryana) India