Biometrics Solutions: Precision Data for Strategic Decisions
We specialize in delivering high-quality biometrics services that support decision-making throughout the clinical development process. Our team of statisticians, programmers, and data scientists utilizes advanced tools and methodologies to turn complex data into actionable insights.
Core Expertise:
- Biostatistics: Protocol development, sample sizing, SAP creation, and statistical analysis for reliable decision-making.
- Statistical Programming: : Expert statistical programming for SDTM, ADaM datasets, and TLF production.
- Data Management: Efficient data collection, quality control, integration, and compliance.
- Data Science: Advanced data curation, harmonization, and visualization for actionable insights.
Cutting-Edge Tools: We use EDC platforms like Rave, our own EDC, OC/RDC, Octalsoft, and Medrio to ensure the highest standards of data collection, management, and analysis, enabling accurate and reliable results throughout the analysis.
Guiding your Path in Regulatory Compliance
At Veeda Lifesciences, we provide strategic regulatory oversight to ensure your clinical trials run smoothly and efficiently. Our services include comprehensive preparation, submission, and tracking of regulatory applications, amendments, and renewals across various global jurisdictions. We monitor each application closely, managing the entire process to streamline approvals and minimize delays.
- Quality Management System: Our QMS ensures stringent risk management, robust training, vendor oversight, data integrity, documentation, validation, and continuous improvement. Centralized trial master file control ensures accurate, complete, and audit-ready documentation
- Inspection readiness: A comprehensive program ensures regulatory compliance through internal audits, QA oversight, document control, quality event management, gap analysis, change control, and proactive quality practices
- Risk Mitigation and Compliance Support: Our dedicated monitoring teams ensure strict adherence to ICH-GCP, GLP, and other global regulatory standards, giving you peace of mind throughout the trial process
Project Management Services: Ensuring Timely, Successful Outcomes
Effective project management is critical to navigating the complexities of drug development. Veeda Lifesciences offers tailored solutions to keep your projects on track, within budget and aligned with your objectives.
- Dedicated Project Manager: Your single point of contact throughout the project lifecycle.
- Clear & Efficient Communication: Ensuring transparency and smooth information flow.
- Risk Management & Mitigation: Identifying and addressing potential risks early to avoid delays.
Medical Affairs Services: Clear, Accurate Documentation for Regulatory Success
At Veeda Lifesciences, our Medical Affairs Services provide end-to-end support for clinical development and regulatory success. From study planning to post-trial support, our comprehensive suite of services ensures scientific accuracy, regulatory compliance, and timely execution.
- Medical Writing:
- Study Protocols & Amendments: Development and revisions aligned with global regulatory requirements.
- Clinical Study Reports (CSRs):ICH-compliant documentation of trial outcomes.
- Safety Narratives & Reports: Detailed adverse events and safety documentation.
- Regulatory Submission Documents:Expertly crafted dossiers, briefing books, and responses for successful approvals.
- Medical Monitoring:
- Continuous oversight of clinical trials to ensure participant safety and adherence to protocols.
- Expert analysis and management of safety signals.
- Scientific Support:
- Literature reviews and gap analysis to provide scientific context and strategy for trials.
- Development of Investigator Brochures (IBs) and manuscripts for publication in peer-reviewed journals.
- Advisory Support:
- KOL engagement and management for strategic insights.
- Participation in advisory boards and preparation of scientific presentations.
