Clinical Research Services
Comprehensive, technology-driven clinical research support from study design to post-marketing surveillance.
Overview
At SafeVig, we offer comprehensive Clinical Research Services designed to support pharmaceutical, biotechnology, and life sciences companies at every phase of the clinical trial lifecycle. Our goal is to enhance the efficiency, accuracy, and compliance of clinical trials—from early-phase research to post-marketing surveillance. Using SafeVig Solutions, we deliver cutting-edge services that optimize clinical trial management, streamline data collection, and ensure timely regulatory compliance.
Study Design & Planning
- Protocol Development: Experts develop robust protocols aligned with regulatory guidelines to ensure study integrity.
- Site Selection & Management: Data-driven selection of clinical trial sites for the right patient population and operational excellence.
- Risk-Based Monitoring (RBM): AI-driven RBM strategies for efficient resource allocation and enhanced patient safety.
Clinical Trial Management
- Project Management: Dedicated managers ensure adherence to timelines, budgets, and regulatory requirements.
- Site Management & Monitoring: Real-time monitoring, streamlined communication, and automated data entry for seamless execution.
- Data Management & Monitoring: Continuous data monitoring with SafeVig Solutions for accuracy and compliance.
Patient Recruitment & Retention
- Targeted Recruitment Campaigns: AI-powered tools for efficient identification and engagement of patient populations.
- Patient Retention Strategies: Personalized engagement and ongoing support to maximize retention and minimize dropouts.
Clinical Data Management & Analysis
- Data Collection & Validation: Accurate data collection and real-time validation with AI/ML across all study sites.
- Data Analysis & Reporting: Automated analytics and actionable real-time reporting for interim and final study insights.
Regulatory Submissions & Compliance
- Regulatory Strategy & Consultation: Guidance on regulatory pathways and compliance for FDA, EMA, ICH, and global standards.
- Clinical Trial Submissions: Preparation and submission of CTAs, INDs, and CSRs in compliance with international regulations.
- Audit & Inspection Support: Inspection-ready data and documentation to minimize risks during audits.
Post-Marketing Surveillance
- Real-Time Safety Monitoring: Integration with pharmacovigilance systems for ongoing tracking of product safety.
- Market Access Studies: Evaluation of long-term performance, patient outcomes, and cost-effectiveness after trial completion.
Why Choose SafeVig for Clinical Research?
- End-to-End Solutions with SafeVig Technology: Integrated AI-powered platform for data management, analytics, compliance, and recruitment.
- Global Expertise & Regulatory Compliance: Experienced team with deep regulatory knowledge, supporting FDA, EMA, ICH, and global standards.
- Customized & Scalable Solutions: Flexible services for all company sizes and all clinical trial phases.
- Enhanced Efficiency & Cost Savings: Automation and AI minimize costs and accelerate trial timelines.
