Regulatory, Clinical, Manufacturing for Pharmaceutical and Medical Devices

Solution by Countries

Our Industries

Data Migration is central, complex and daunting theme of a digital transformation initiative by organizations, whether large, medium or small. Artixio, with its deep domain experience and solid understanding of regulatory, clinical, manufacturing, supply chain and commercial processes and data, coupled with decades of experience in digital transformation, artificial intelligence / machine learning engineering and data science supports pharmaceutical, medical devices, biotech, food, nutraceutical, cosmetics and other life sciences industry with seamless data migration services.

Artixio’s Data Migration Support – Key Highlights

Comprehensive Phased Approach for Data Migration

Discover Legacy Systems and Data Inventory (MasterControl, TrackWise, Custom RIMS, SAP Systems, Excel Sheets, SharePoint and others)
Data Gap Analysis between Legacy Data Sources and Potential New Strcuture (such as Veeva Vault, RIMS)
Define scope of migration across products, markets, registrations, submissions, documents, SOPs, processes and activities)
Data cleansing, metadata mapping and data annotation strategies

Solutions We Have Built:

Our Team Composition:

Data Migration Architects (Veeva)
Data Migration Specialists (Veeva RIMS/QMS/Clinical)
Regulatory and Quality Data Subject Matter Expert
Integration Engineers / ETL
CSV / QA Validation Specialists
Project Managers
Data Analyst / Quality Specialists

Our Engagement Models:

Global Regulatory Intelligence Platform (QuriousRI)

Global Predicate Analysis for Drugs and Devices
Regulatory Classification Assessment
Regulatory Pathway Analysis
Regulatory Guidelines and Insights
Compare Regulations
Dossier Requirements
Dossier Gap Analysis
Assisted Document Authoring
Global Submissions Management
Ongoing Regulatory Intelligence Monitoring & Impact Analysis
Competitor Tracking and Intelligence

Success Stories

Artixio has deployed experienced Veeva data migration specialists for several mid sized pharma and consulting companies globally.

Why Artixio For Your AI Regulatory Services?

Deployed AI Solutions for Global Top 10 Pharma and MedTech/BioTech/HealthTech Startups
Proven Experience Across Drug/Device Development, Regulatory and Clinical Processes
Regulatory, Clinical Domain Experts and AI Architects for Solution Design
Data Governance, System Validation and Audit Trail Management
Full-Stack Engineers for Secure and Scalable Development
Efficient Product and Project Management
Regulatory/Clinical Experts for Data Management, Annotation and Ongoing Maintenance

FAQs

What are the tools and technologies used for Data Migration?

Multiple tools are used for different aspects through the data migration program. The tools include, but not limited to, Veeva Utilities: Vault Loader, Vault REST APIs; ETL Tools: Talend, Boomi, Informatica, Python, SQL; Validation Frameworks: CSV templates, 21 CFR Part 11 compliance and Reporting: Power BI / Tableau dashboards for data quality metrics.

What are the challenges faced during data migration?

There are many challenges faced by organization during data migration as part of digital transformation. Some of the challenges include, multiple, unstructured data sources, data quality issues, data consistency, complexity of data mapping and metadata structures, high volume of data, system performance leading to high upload times, downtimes, failures, validation and compliance issues, change management, communication, user adaption related issues, multi-system integration, audit readiness, governance issues.

How can Artixio can help with our Data Migration requirements?

Artixio’s team and wide network of experts include full pod data migration experts from strategic data migration consultants, architects, regulatory and clinical data subject matter experts, data migration experts, data quality and validation experts and others. Right from discovery and assessment, data migration planning through execution, Artixio can deploy the right experts to help you accomplish your business objectives.