Clinical trial data management

Traceable. Compliant. Ready for submission. 

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Clinical trials produce a wide range of data, from structured CRFs to free-text lab notes and consent forms. However, fragmented formats and disconnected systems hinder effective tracking, integration, and governance of this information. 

Datavid helps sponsors, CROs, and regulatory teams transform complex clinical content into structured, validated, and submission-ready knowledge, reducing risk, saving time, and enhancing patient safety. 

The complexity of clinical data today

Fragmented data delays trials and increases risk 

Clinical trials depend on their data. But when key information is spread across incompatible formats and systems, important insights are lost or, worse, submissions are delayed.  

While CRFs provide structured inputs, most study information stays unstructured and inconsistently formatted. 

Common pain points include: 

DataPipeline
Reconciliation gaps between CRF and non-CRF data
ProcessAutomation
Manual work to prepare submission documents
Time
Audit delays caused by missing metadata or traceability
DataSilo
Disparate systems used by sites, CROs, and sponsors
ComplianceAudit
High volume of data quality checks and regulatory compliance

And with strict oversight from agencies like the FDA and EMA, any mistake in clinical data management can lead to delays, rework, or costly risk exposure. 

Quote
Datavid has talented & very knowledgeable people with expertise in data, digital & AI problem solving. I like their flexibility & speed, friendly mannered team & ease of collaboration.
Ameeq Mohammad, ​Molecular Diagnostics Account Specialist, Roche
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Where Datavid delivers value

A smarter, structured way to handle trial data 

Datavid provides a clinical data framework that automates trial content's transformation, validation, and traceability throughout its lifecycle.  

Our approach connects structured and unstructured content, ensuring submission deadlines are met while boosting confidence in the data. 

Our platform is designed to: 

Reconcile
Reconcile CRF and non-CRF data streams
Transform content
Transform content into reusable, standardized formats
Ensure traceability
Ensure traceability is audit-ready at all stages
Support clinical document
Support clinical document authoring and governance
Seamlessly integrate
Seamlessly integrate with current clinical systems and workflows.
Whether you’re managing a global Phase III study or preparing your first eCTD submission, Datavid helps decrease the chaos. 

Key features

Everything you need for structured, compliant clinical content.
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KnowledgeGraph

Semantic enrichment of clinical content

Tag, organize, and connect data across protocols, notes, CRFs, and submissions for machine-readability and interoperability.
Quality Assurance

Data Quality Controls (DQC)

Automated validation and error detection ensure content complies with internal and regulatory standards before review.
Metadata

Metadata modeling pipelines

Design and oversee ingestion workflows that use consistent metadata, taxonomies, and terminology throughout the trial stack.
DataArchitecture

Modular & low-code architecture

Adapt quickly to new document types, regulations, or site-specific requirements–without heavy rework or vendor lock-in.
Cycle

Lifecycle automation

Monitor every stage of a clinical document’s life cycle, from initial authoring to final structured output, ensuring traceability and compliance.

Outcomes that matter

Faster timelines. Reduced risk. Improved visibility. 

Datavid enables clinical and regulatory teams to: 

rocket

Accelerate site onboarding and data ingestion

ProcessAutomation

Eliminate manual reconciliation across document types

Feature Icon

Enhance traceability for audits and agency inspections

Future

Accelerate CTD/eCTD preparation with structured outputs

DuplicatedData

Minimize reviewer fatigue and avoid duplicated effort

Compliance

Ensure compliance with FDA, EMA, and ICH guidelines

The outcome: increased confidence in submissions, fewer delays, and more effective use of internal resources.

Specific use cases we support

Flexible with sponsor, CRO, & reg teams

Flexible with sponsor, CRO, & reg teams

Datavid integrates with your CDMS, eTMF, and CMS systems, enhancing their value without replacing them.
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Biopharma sponsors

Biopharma sponsors

Unify disparate trial systems and improve submission readiness with reusable data assets and content pipelines.
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Contract research org

Contract research org

Standardize and streamline data across trials, sponsors, and platforms, enhancing service quality and operational capacity.
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Regulatory affairs

Regulatory affairs

Manage metadata and document history across eCTD modules with complete traceability and built-in validation.
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Clinical docs & trial designers

Accelerate protocol development and ensure precise document reuse with structured authoring and AI-ready formats.
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A trusted partner in Life Sciences

Datavid has extensive experience supporting clinical and research data environments. Whether you’re managing adaptive trials or coordinating global studies, our semantic and metadata-driven approach helps you scale confidently. 

We develop systems as rigorous as your science, supported by real-world delivery in regulated environments. 

Real Results for Leading Scientific Publishers

Roche

rom bottlenecks to breakthroughs: Modernizing clinical data at scale

Datavid transformed Roche’s clinical data platform by migrating it to a scalable, cloud-native architecture and introducing automation across the delivery pipeline. The result was a faster, more reliable, and compliant system that significantly improved performance, streamlined operations, and empowered research teams with timely access to critical data.
  • 1B+ documents processed
  • 360+ clinical trials
  • 50+ TB of harmonized data
  • ~2 days AWS migration downtime
Roche Case Study case study

Frequently Asked Questions

How can Datavid help make clinical trial data submission-ready?

Datavid structures and reconciles CRF and non-CRF data, applies semantic enrichment, and enforces metadata standards. This ensures every dataset is traceable, compliant, and aligned with FDA, EMA, and ICH guidelines - reducing submission delays and audit risks.

Why is clinical trial data management so complex?

Clinical trials generate structured CRFs alongside unstructured lab notes, consent forms, and reports. Disparate formats, manual reconciliation, and siloed systems make it hard to ensure consistency, traceability, and compliance. Datavid automates ingestion, validation, and lifecycle management to minimize errors and speed up trial timelines.

How does semantic enrichment improve clinical trial data quality and AI readiness?

Semantic enrichment links trial data to ontologies, vocabularies, and metadata models, creating standardized, machine-readable outputs. This not only improves traceability for audits but also makes trial data “AI-ready,” enabling advanced analytics, predictive models, and GenAI applications for faster insights.

Is your trial data well-structured, traceable, and ready for submission?

Let’s make your clinical data support your timelines and compliance objectives.
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