Data Migration Services
Regulatory, Clinical, Manufacturing for Pharmaceutical and Medical Devices
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
Regulatory, Clinical and GxP Data Experience and Expertise
Flexible and Scalable Engagement Models
Cross-Functional Technology and Subject Matter Experts Teams
Compliant Solutions for Validation and Audit Readiness
Comprehensive Phased Approach for Data Migration
Pre-Migration Discovery and Assessment
- 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
Validation and Testing
- Reconciliation and Verification of Data
- Audit Trails
- User Acceptance Testing for end users across business units
- Traceability documentation as per GXP compliance requirements
Mapping Data and Transformation Planning
- Build data maps between source data fields and new RIMS metadata fields
- Develop rules for transformation including data formats, data standardization, removing redundancies
- Develop Extraction Transformation Load logic
Post Migration Hypercare
- Continuous Data Quality Monitoring
- Improvements, Enhancement and Re-Mapping
Execute Migration
- Data extraction from legacy systems
- Transformation scripts
- Upload in new RIMS using APIs and migration utilities
- Validation of Uploaded Data
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:
- Time and Material Model: Hourly or Monthly retainer model for select specialist
- FTE Model / Contract Staff: Long Term deployment of team as part of continuous migration roll out
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.
Still Have Questions ?
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Specialized Regulatory
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Services Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
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USA
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Qatar
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