Comprehensive Pharmacovigilance Services for Safer Clinical Outcomes

Ensuring Patient Safety and Compliance

At Kinesis, our Pharmacovigilance (PV) services are dedicated to the proactive monitoring, assessment, and management of drug safety throughout the entire product lifecycle. We are committed to safeguarding patient well-being and ensuring rigorous adherence to global regulatory requirements, providing robust safety reporting and expert insights.

Why Kinesis for Pharmacovigilance?

Partnering with Kinesis for pharmacovigilance ensures that your drug safety operations are managed with expert oversight, regulatory acumen, and a proactive approach to patient well-being.

Unwavering Focus on Patient Safety

Our primary commitment is to patient safety, which drives our meticulous processes and vigilance in monitoring and reporting adverse events, ensuring responsible product stewardship.

Global Regulatory Compliance

We maintain an up-to-date understanding of evolving global pharmacovigilance regulations (e.g., EMA GVP, FDA 21 CFR Part 314/600, ICH guidelines), ensuring your activities are always compliant and submission-ready.

Proactive Risk Management

Beyond just reporting, we engage in proactive signal detection and risk management strategies, helping you identify and mitigate potential safety concerns early in the product lifecycle.

Experienced & Dedicated Team

Our team comprises highly experienced pharmacovigilance specialists, medical reviewers, and safety writers who bring deep therapeutic knowledge and operational excellence to every task.

Benefits for Your Product Lifecycle

Engaging Kinesis's pharmacovigilance expertise delivers critical advantages that safeguard your products and reinforce stakeholder confidence.

Enhanced Patient Protection

Our vigilant monitoring and robust reporting systems contribute directly to better patient safety outcomes by ensuring adverse events are promptly identified and managed.

Regulatory Audits & Inspections

With meticulously managed data and comprehensive documentation, you gain confidence in facing regulatory audits and inspections, minimizing findings and ensuring continuous compliance.

Optimized Resource Efficiency

By entrusting your pharmacovigilance activities to Kinesis, you can optimize your internal resources, reducing overhead and allowing your core teams to focus on development and commercialization.

Timely & Accurate Safety Insights

We provide timely and accurate safety data and insights, enabling quick decision-making regarding product safety profiles and risk-benefit assessments.

Individual Case Safety Report (ICSR) Processing

Serious Adverse Event (SAE) Reconciliation

Signal Detection & Risk Management

Medical Review & Safety Narrative Writing

Pharmacovigilance System Master File (PSMF) Management

Post-Marketing Surveillance & Safety Monitoring

Periodic Safety Update Reports (PSURs / PBRERs)

Your Data Deserves Precision.

At Kinesis, we don’t just manage data—we drive insights. Explore how our tailored biometrics solutions can elevate your clinical research.

Let’s Talk Clinical