Life Sciences

The relentless pace of scientific discovery in life sciences hinges on precision information management. Navigating immense data volumes, stringent global regulations, and intricate collaborative networks often challenges progress

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Accelerating innovation with controlled content in Life Sciences

Integrating historical R&D and clinical archives

Preservation of historical research and clinical insights. Transitions of legacy research findings and clinical trial data. Uninterrupted access for global research groups

Propelling development and submission timelines

Instant, secure access to visualize and annotate intricate study protocols, sensitive patient data, or vital submission elements, all within their native workflow environment, removing external application needs

Centralizing knowledge across scientific functions

Build a cohesive information framework. Unify documentation from R&D, clinical operations, regulatory, and quality management. Fortify GxP adherence, and simplifying audit preparations

Ensure end-to-end gxp compliance and audit readiness

Embed unyielding regulatory compliance throughout every life sciences operation (FDA 21 CFR Part 11, EMA guidelines, and GxP standards) with automated retention policies and stringent access controls

What is your context?
Lab discovery, global product launch, your context shapes the flow of critical scientific and operational information
 
If you are managing gxp-regulated data

 

ARender for versatile document access and review

ARender ensures universal, unhindered visibility into all life sciences documentation. It expertly renders diverse file formats such as intricate raw data outputs, high-resolution imaging, extensive study reports, and precise regulatory templates, streamlining critical review processes without requiring specific software

 

 

FlowerDocs search & indexing engine

The FlowerDocs NoSQL core integrates deeply within your infrastructure, providing powerful indexing and swift retrieval. Rapidly locate any unstructured GxP content, encompassing granular lab results, patient clinical notes, eCTD components, and rigorous quality records, for immediate data utilization

 

 

Fast2 for automated data ingestion pipelines

Fast2 engineers efficient pipelines for capturing and normalizing complex life sciences data streams. It intelligently automates the high-volume intake and structuring of disparate content, from direct lab instrument feeds and clinical site submissions to external CRO data, preparing every record for processing

 

 

Robust gxp data stewardship

Establish unwavering command over sensitive GxP datasets. Implement meticulous controls for data visibility and usage, configured precisely by content type, study phase, or specific regulatory classification, thereby ensuring absolute compliance with no added administrative burden

If you are migrating legacy gxp systems or moving to cloud environments

 

Fast2 for comprehensive system migrations

Fast2 provides a secure, high-volume conduit for transitioning extensive historical research, clinical trial records, and essential quality documents from legacy EDMS/QMS solutions. It meticulously ensures data integrity and preserves audit lineage during migration to modern platforms or validated cloud environments.

 

 

ARender for migration data validation

ARender confirms the fidelity of migrated GxP documents, ensuring continuous operational utility post-transfer. It allows immediate viewing of all converted files in their native format, enabling swift verification and validating that embedded annotations, electronic signatures, and redactions remain fully accessible

 

 

FlowerDocs as your next-generation gxp repository

Post-migration, FlowerDocs establishes a scalable, adaptive content foundation designed for all your GxP documentation. It unifies fragmented information from past systems into a single, intelligently structured repository that flexibly evolves with data models and regulatory needs

 

 

Auditable data transfer oversight

Maintain complete oversight and auditability throughout data transfers. Define and enforce precise access and transformation rules for migrated GxP content, aligning with all retention policies and regulatory mandates

 

If you need uncompromised gxp compliance and audit trails

 

ARender for secure data visualization

ARender actively protects sensitive patient data and intellectual property within documentation, initiating safeguards before content even reaches user interfaces. It executes high-volume, automated redactions, data masking, or file-level encryption at the point of origin, ensuring strict compliance with HIPAA, GDPR, and GxP data integrity before content is displayed

 

Fast2 for compliant data preprocessing

Fast2 ensures all incoming life sciences content meets stringent compliance standards immediately upon ingestion. It can automatically apply initial classification, tagging, and even pre-redaction protocols as records enter your system, establishing a framework for entirely compliant workflows

 

 

FlowerDocs for enterprise-wide gxp control

FlowerDocs embeds rigorous GxP compliance directly into your entire content lifecycle. It automatically enforces retention schedules, legal holds, and stringent version controls, ensuring every research record, clinical document, and quality interaction meets regulatory mandates and is fully auditable

 

 

Role-based access for regulated information

Control user access based on roles, GxP requirements, and content sensitivity. Manage permissions at a highly granular level across your entire repository, ensuring only authorized personnel can view or interact with sensitive data

 

If you are collaborating across global research or clinical sites

 

FlowerDocs for centralized project documentation

FlowerDocs provides comprehensive global visibility into study and project files while maintaining site-specific detail. It consolidates all documentation into a centralized view, yet accommodates local regulatory and privacy rules. This empowers global teams to manage R&D and clinical tasks efficiently, avoiding duplication and maintaining oversight

 

Fast2 for global data synchronization

Fast2 ensures all research and clinical documentation remains perfectly aligned across core systems, international sites, and partner organizations. It expertly manages format harmonization, incremental updates, and secure cross-entity transfers, providing fully traceable content flows at all times

 

ARender for secure cross-site review

ARender facilitates seamless, secure cross-jurisdictional collaboration on shared files, eliminating format incompatibilities and compliance worries. Every reviewer accesses precisely the version they are authorized to see, supported by audit-proof annotation and redaction tools, ensuring consistent insights globally

 

Adaptable global access controls

Manage document access based on study role, country, or data sensitivity. Control visibility at scale without multiplying infrastructure or increasing manual overhead, ensuring secure, controlled access to sensitive global research and clinical data

Optimizing the continuum: discovery to commercialization
 
 
Let's dive into the major lines of business of the Life Sciences Industry!

  • eTMF Trials

  • Preclinical Workflows

  • Regulatory compliance

Clinical trial execution and data management (eTMF)

Keep every clinical trial process structured, traceable, and in sync, from patient enrollment to database lock

 

Patient enrollment and informed consent

The clinical trial journey transforms patient screening into organized digital records. Upon enrollment, patient consent forms, source documents, and initial assessment data are swiftly uploaded or scanned. FlowerDocs immediately captures, tags, and structures information into a dedicated electronic Trial Master File (eTMF) for the subject. This includes instant content capture, indexing, and automated routing

 


Clinical data and document review

Clinical monitors and data managers pivot from document handling to focused data review. They instantly access CRFs, adverse event reports, and patient notes directly within their workflow. ARender ensures all documents are viewable, annotatable, and version-controlled, regardless of format:

  • Zero-download viewer for instant access for global teams
  • Integrated redaction capabilities for patient privacy
  • Comprehensive traceability for every review and data change

 

Study data finalization and database lock

The study approval and database lock phase confirms data finalization with confidence. Following data cleaning and validation, final study reports and statistical analyses are generated and securely signed. FlowerDocs immutably locks the final database version, logging the event and associating updates or amendments with clear version history. The study is then ready for regulatory submission

 


Ongoing site documentation and essential updates

Maintain precise control over evolving trial documentation with real-time content updates. Site visit reports, monitoring logs, and external lab results integrate flawlessly, free from duplication or formatting discrepancies. Fast2 automates daily processing of site uploads, vendor data, and emails, ensuring content routes to the correct eTMF and synchronizes with clinical operations teams

 


Trial closeout and long-term archival

Clinical trials are closed cleanly and archived with confidence. Once a trial is completed or terminated, FlowerDocs automatically applies predefined retention rules aligned with regulatory requirements. Fast2 facilitates migration of historical clinical data from older systems into a consistent structure, ensuring it is instantly ready for regulatory audits and compliance reviews:

  • Automated lifecycle management and robust retention enforcement
  • Meticulous metadata cleanup for data integrity
  • Ensures GxP compliance and inspection readiness

 

Historical clinical document conversion

Address the challenge of managing years of historical clinical trial records. Fast2 efficiently migrates legacy eTMFs or paper trial files into your current structured environment. It harmonizes metadata, aligns various document formats, and transforms dormant archives into readily usable, living resources for ongoing research and regulatory compliance

Preclinical workflows and R& D

From initial hypothesis to preclinical validation, ensure your R&D data is precisely captured, securely managed, and readily accessible

 

Experimental data capture and documentation

New research hypotheses and experimental designs drive the process. Raw lab data, researcher notes, and study protocols are captured. FlowerDocs immediately stores and organizes this diverse intake into a structured digital folder for each project. This ensures instant content capture, indexing, and automated folder assignment, reducing delays

 


Study design and protocol lifecycle

Researchers need clarity for robust experimental design. ARender provides immediate access to view and annotate study protocols, lab reports, and experimental data. This eliminates tedious downloads and format issues. Comments and approvals link to the document version, ensuring meticulous tracking and auditability for every review

 


Preclinical data analysis and reporting

Following successful experiments and analysis, rapid data reporting is essential. Preclinical study reports and findings are swiftly produced, validated, and secured with electronic signatures. FlowerDocs immutably locks the signed versions, recording the reporting event. Subsequent updates or annexes are systematically stored, maintaining clear lineage. Reports are instantly finalized for review

 


Continuous knowledge and ip integration

Evolving research demands continuous data flow. As new data points, publications, or intellectual property documents emerge for ongoing projects, they are ingested in real time and precisely indexed. Fast2 expertly manages batch injections of external data, ensuring all content is clean, structured, and instantly searchable as the project file expands

 


R&D record retention and archival compliance

Upon research completion or IP filing, complete documentation is paramount. Every action is meticulously recorded, IP disclosures are properly filed, and predefined retention rules are automatically applied. This ensures no operational step is ever left undocumented or unverifiable, guaranteeing full audit readiness for every new discovery

Regulatory affairs and quality systems management

Maintain stringent compliance and ensure rapid market access through robust regulatory and quality content control

 

Regulatory submission dossier preparation

Regulatory teams gain instant, secure access to all required documentation for submission dossier assembly through FlowerDocs. This includes R&D reports, clinical summaries, and manufacturing details, meticulously organized for eCTD compilation, eliminating waiting time or misplacement


Quality document control & versioning

Precision is paramount when processing SOPs, quality records, or regulatory amendments. ARender enables immediate viewing and annotation of all related document changes, guaranteeing every reviewer accesses the accurate version:

  • All modifications are thoroughly tracked
  • Ensures a complete audit trail for GxP compliance

Quality event management & CAPA documentation

Efficiently manage deviation reports, non-conformances, and CAPA documentation. Fast2 ensures all incoming quality-related documents, whether from internal systems or external audits, are precisely tagged, routed, and seamlessly integrated into the correct quality record in real time. This allows the QMS file to expand while remaining perfectly organized and instantly searchable:

  • Handles content from internal systems or external audits
  • Allows the QMS file to expand dynamically
  • Ensures records remain perfectly organized and instantly searchable

Agency communication & correspondence

Every interaction with regulatory agencies, including submissions, queries, and approvals, is automatically captured, indexed, and meticulously stored within the regulatory dossier. This robust process establishes a complete audit trail and ensures seamless communication continuity, making every agency touchpoint traceable

 


Regulatory record retention & auditability

Throughout a product's lifecycle and upon its market withdrawal, preserving its complete regulatory and quality history is vital. FlowerDocs automatically enforces predefined lifecycle rules and retention policies (e.g., for 21 CFR Part 11). All historical regulatory data, including superseded versions and associated correspondence, is securely archived and remains entirely auditable for agency inspections and future reference

Read more about what we do @Uxopian...
Training

Introducing Uxopian Academy

Join Uxopian Academy for free self-paced courses on Flowerdocs, eProcess, ARender and Fast2. Start with our Fast2 practitioner course to grow your...

Uxopian Software Jul 3, 2025

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