Clinical Data Management
Empowering life sciences with intelligent, secure, and compliant clinical trial data solutions.
Overview
At SafeVig, we provide comprehensive Clinical Data Management (CDM) services designed to ensure the accuracy, integrity, and compliance of your clinical trial data. Our solutions leverage advanced technology, including AI, Machine Learning, and Automation, to streamline the entire data management process. Using SafeVig Solutions, we enable real-time, high-quality data processing and regulatory compliance at every step of your clinical trial lifecycle.
Data Collection & Validation
- Electronic Data Capture (EDC): Seamless integration with clinical sites, reducing manual data entry errors and boosting data quality.
- Real-Time Validation: Instant flagging of data inconsistencies, missing fields, and discrepancies for superior data integrity.
- Automated Data Cleaning: Tools to resolve data discrepancies and ensure high-quality, analysis-ready datasets.
Data Integration & Aggregation
- Multi-Source Aggregation: Unified datasets from EDC, PRO, laboratory reports, and CTMS for comprehensive analysis.
- Cross-System Integration: Integrates seamlessly with safety reporting, pharmacovigilance, and compliance platforms.
Data Analysis & Reporting
- Real-Time Analytics: AI/ML algorithms provide deeper insights into study performance, safety, and efficacy.
- Customizable Reports: Tailored for interim analysis, regulatory submission, or publication, with quick turnaround.
Regulatory Compliance & Submission
- Audit-Ready Data: Transparent, organized, and compliant with 21 CFR Part 11, GxP, and international standards.
- Automated Submission: Streamlines Clinical Study Report (CSR) generation and timely regulatory filings (IND, NDA, etc.).
Data Security & Confidentiality
- End-to-End Encryption: All data encrypted at rest and in transit, with regular backups.
- Role-Based Access Control (RBAC): Strict access management ensures confidentiality and study integrity.
Post-Trial Data Management
- Long-Term Data Storage: Secure, compliant archival for future reference, audits, or regulatory inspections.
- Post-Trial Analysis: Organized datasets for easy retrieval and follow-up studies or publications.
Why Choose SafeVig for Clinical Data Management?
- Advanced Technology & Automation: AI-driven tools and cloud-based access for fast, error-free data management.
- Compliance with Global Regulations: FDA, EMA, ICH, GxP, 21 CFR Part 11, and more.
- End-to-End Data Management: From collection to regulatory submission, always audit-ready.
- Real-Time Analytics: Make informed decisions throughout the trial with actionable, real-time insights.
- Data Security & Confidentiality: Highest security standards, role-based access, full encryption.
