Shadow™ is an advanced clinical data de-identification tool for CROs, designed to help Life Sciences organizations accelerate regulatory submissions while maintaining complete compliance, control, and data integrity. As a next-generation data anonymization tool pharma companies trust, Shadow™ unifies EMA Policy 0070 compliance software, 21 CFR Part 11 data masking, CDISC SDTM anonymization, and clinical document redaction software into a single enterprise-grade platform.
Built for scalability and precision, Shadow™ enables CROs and pharma teams to reduce turnaround times, eliminate manual inefficiencies, and deliver submission ready outputs with confidence while remaining fully compliant with all major regulatory frameworks.
It automates the de-identification of structured clinical datasets (CDISC SDTM, ADaM), unstructured clinical documents (CSRs, protocols), and DICOM medical images, ensuring compliance with global data transparency regulations including EMA Policy 0070 (Initial and Revised), Health Canada, PHUSE GTP and De-Identification Standards, 21 CFR Part 11, and GDPR & TransCelerate Guidance Developed and maintained by GENINVO, Shadow™ is backed by ISO 27001, ISO 9001, and SOC 2 certifications.
Shadow™ is a purpose-built clinical data de-identification tool for CROs that transforms how organizations approach anonymization. Instead of relying on fragmented tools or manual processes, Shadow™ delivers an integrated platform that combines data anonymization tool pharma capabilities with automated clinical document redaction software.
With built-in EMA Policy 0070 compliance software and 21 CFR Part 11 data masking, Shadow™ ensures that every dataset, document, and image is processed in accordance with global regulatory requirements. Its native CDISC SDTM anonymization capabilities allow teams to handle structured datasets efficiently while maintaining analytical integrity.
| Regulation / Framework | Scope | Shadow™ Status |
|---|---|---|
EMA Policy 0070 (Initial & Revised) | Clinical data transparency for EU submissions. | ✔ Fully Compliant |
Health Canada | Health Canada public release of clinical Information | ✔ Fully Compliant |
EU CTR (Clinical Trials Regulation) | EU Clinical Trials Regulation data transparency and public disclosure obligations for clinical trial results | ✔ Fully Compliant |
21 CFR Part 11 (FDA) | Electronic records & electronic signatures for US submissions | ✔ Validated |
GDPR | EU personal data protection clinical data and patient records | ✔ Compliant |
PHUSE GTP and De-Identification Standards | Industry guidance for clinical data de-identification strategy application | ✔ Fully Compliant |
TransCelerate Guidance | Cross-industry de-identification guidance for pharma R&D transparency | ✔ Fully Compliant |
CROs and medical writers managing clinical data transparency face critical operational and compliance challenges that directly impact timelines, costs, and regulatory confidence—challenges that Shadow™ is purpose-built to solve as a leading clinical data de-identification tool for CROs:
Shadow™ by GENINVO solves all three challenges as a purpose-built clinical data de-identification tool for CROs. Organizations using Shadow™ report significant reductions in the time required to complete clinical document redaction compared to manual or script-based approaches. Teams managing large CDISC SDTM and ADaM portfolios benefit from pre-built strategy repositories that eliminate the need to rebuild de-identification rules from scratch for every study. And because Shadow™ generates audit-ready re-identification risk reports automatically, regulatory reviewers receive the documentation they expect without additional manual effort from your team.
Looking to enhance your organization’s impact?
GENINVO’s technology-empowered experts are available to assist you in the following areas:
Anonymize structured datasets (CDISC SDTM, ADaM), clinical documents (CSRs, protocols), and DICOM medical images in a single unified platform.
Store and apply de-identification strategies at Global, Therapeutic Area, Compound, Study, and Project levels. Comes with pre-built CDISC SDTM and ADaM strategies out of the box.
Define reusable templates to apply large sets of strategies in one action — dramatically reducing time and effort across recurring studies.
See the live effect of each de-identification rule applied to your data or document in real time before finalizing, eliminating costly errors.
Search a continuously updated repository of already-published Commercially Confidential Information (CCI) to inform redaction decisions before starting a new project.
Quantify re-identification risk before and after de-identification to demonstrate compliance with EMA and Health Canada thresholds with full audit trail.
Measure the impact of anonymization on analytical utility so downstream consumers can still reproduce key analyses from de-identified datasets.
Track and report on de-identification team precision, strategy effectiveness, and workflow throughput to optimize resource allocation.
Apply de-identification strategies created for an English document directly to foreign-language versions of the same document saving significant time for global submissions.
Automatically generate Redaction Proposals and Anonymization Reports required for regulatory submissions fully audit-ready.
Step-by-step workflow guidance for your entire project team through de-identification, review, approval, and final anonymization stages.
Shadow™ ships with full validation documentation to support GxP deployment in regulated environments without burdening your IT or QA team.
Shadow™ is a purpose-built clinical data de-identification tool for CROs, designed for Life Sciences professionals
working at the intersection of data transparency, regulatory compliance, and clinical science.
Shadow™ by GENINVO is a globally deployed clinical data de-identification tool for CROs, supporting Life Sciences organizations across North America, Europe, and Asia-Pacific. Its compliance coverage spans all major regulatory jurisdictions where clinical data sharing obligations apply: the European Union (EMA Policy 0070), the United States (21 CFR Part 11, FDA), Canada (Health Canada). Whether your team is headquartered in the US, EU, or operates across multiple regions,
Shadow™ provides a single validated platform for all your clinical data transparency requirements.
As a purpose built clinical data de-identification tool for CROs, Shadow™ guides entire team through a structured, auditable workflow from strategy definition to submission-ready output ensuring speed, consistency, and regulatory confidence at every stage:
Define Strategy: Quickly select or configure de-identification strategies using the built-in CDISC SDTM / ADaM repository, or create custom rules at the Global, TA, Compound, Study, or Project level to standardize processes across programs.
Apply & Preview: Apply rules with an intuitive dual-frame, before-and-after view, allowing your team to validate changes in real time and eliminate errors before finalization.
Risk Analysis: Instantly assess re-identification risk to ensure your anonymized datasets meet EMA Policy 0070 and Health Canada thresholds with confidence.
Validate Utility: Leverage data utility analysis tools to maintain the analytical value of your datasets, ensuring downstream usability without compromising compliance.
Generate Reports: Automatically generate Redaction Proposals, Anonymization Plans, and Anonymization Reports—fully audit-ready and formatted for seamless regulatory submission.
Review & Approve: Streamline collaboration with built-in workflows that route content for review and sign-off by QA, regulatory, and leadership teams.
Shadow™ is trusted by Life Sciences companies and CROs globally to deliver compliant, auditable, and scalable clinical data anonymization. See how Shadow™ can replace your homegrown scripts, accelerate your EMA 0070 submissions, and give your team confidence in every de-identified dataset.
Shadow™ is a clinical data de-identification and anonymization software developed by GENINVO, a Life Sciences technology company. It is purpose-built for CROs, pharmaceutical companies, and medical writers who need to comply with EMA Policy 0070, Health Canada, 21 CFR Part 11, and GDPR data transparency requirements. GENINVO designed Shadow™ to replace inefficient homegrown scripts and manual redaction workflows with an enterprise-validated, audit-ready platform.
Shadow™ by GENINVO is fully compliant with both the Initial and Revised phases of EMA Policy 0070, covering both document-level Clinical Study Report (CSR) redaction and structured dataset de-identification. This means organizations can use a single platform to address all EMA 0070 obligations — from preparing the anonymized CSR for public disclosure to generating the required Anonymization Plan and re-identification risk documentation.
Shadow™ is a validated 21 CFR Part 11 compliant solution, and it ships with a complete validation documentation package. This means your IT and QA teams do not need to build validation infrastructure from scratch — the evidence required for GxP deployment is provided as part of the product. GENINVO’s Shadow™ is also GDPR compliant and certified to ISO 27001 and SOC 2 standards.
Shadow™ handles three types of content in a single integrated platform: structured clinical datasets (CDISC SDTM and ADaM), unstructured clinical documents (CSRs, protocols, synopses), and DICOM medical images. This makes Shadow™ by GENINVO one of the few clinical de-identification tools that eliminates the need for separate systems for data and document anonymization — a key advantage for CROs managing complex, multi-format de-identification programs.
Shadow™ by GENINVO is an enterprise-validated platform built specifically for Life Sciences regulatory compliance; ARX is a free, open-source, research-oriented tool that requires significant IT configuration and has no built-in regulatory workflow. Shadow™ includes pre-built CDISC SDTM and ADaM strategies, document-level CSR redaction, DICOM image anonymization, 21 CFR Part 11 validation, regulatory report generation, multi-language strategy support, and team performance metrics — none of which are available in ARX. For organizations with GxP requirements and regulatory submission deadlines, Shadow™ is the purpose-fit alternative.
Shadow™ by GENINVO includes a Multi-Language Strategy Import feature that allows de-identification strategies created for an English document to be imported and applied to the same document in any other language. For global pharmaceutical submissions where the same CSR is submitted in multiple languages, this capability can reduce the effort required to anonymize non-English document versions by a significant margin.
Shadow™ stores and applies de-identification strategies at five hierarchical levels: Global, Therapeutic Area (TA), Compound, Study, and Project. This means organizations can maintain a master strategy library while allowing study-level customizations — a critical capability for CROs managing multiple sponsors with different de-identification requirements on the same platform.
Shadow™ by GENINVO automatically generates Redaction Proposals, Anonymization Plans, and Anonymization Reports formatted for regulatory submission to the EMA, Health Canada, and other authorities. It also produces performance metrics reports for internal quality governance. These auto-generated documents eliminate the manual effort of assembling submission-ready documentation and ensure consistency across every project.
Replacing homegrown de-identification scripts is one of Shadow™’s most common deployment use cases. Homegrown utilities are difficult to validate for 21 CFR Part 11, hard to maintain as regulations evolve, and rarely generate the audit documentation regulators expect. Shadow™ by GENINVO provides a governed, validated replacement that keeps pace with regulatory changes — including EMA Policy 0070 revisions — without requiring your team to maintain custom code.