<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=7238636&amp;fmt=gif">

Safety & Pharmacovigilance Solutions

Empowering Safer, Smarter Clinical Trials with PV Technology

Improve safety data collection, reporting, and regulatory compliance with expert pharmacovigilance support and flexible technology solutions designed to meet the unique needs of your clinical trial.

SDC's safety and pharmacovigilance services helping sponsors ensure compliant, regulator-ready drug safety oversight with SafetyEasy

Why Is Safety & Pharmacovigilance Critical to Clinical Trial Success?

Patient safety is at the heart of every successful clinical trial. Effective pharmacovigilance (PV) is essential for identifying, assessing, monitoring, and reporting adverse events throughout the clinical development lifecycle. As regulatory requirements continue to evolve, sponsors need safety solutions that deliver accuracy, efficiency, compliance, and visibility across every stage of the study.

Managing serious adverse events (SAEs), adverse events of special interest (AESIs), and other safety data requires more than technology alone. It demands expert oversight, streamlined workflows, and rapid communication to ensure potential risks are identified early and regulatory obligations are consistently met.

At SDC, we combine deep clinical expertise with innovative technology to empower better safety decisions, reduce operational burden, and support the delivery of high-quality clinical trial outcomes.

How SDC Experts Support Your Pharmacovigilance Program

SDC delivers flexible, scalable pharmacovigilance solutions tailored to the specific requirements of your study. Whether your trial requires streamlined SAE management within an EDC environment or comprehensive global safety surveillance, our experienced safety professionals provide the oversight and support needed to maintain compliance and protect patient safety.

Integrated eSAE Workflows Within Your EDC
SDC offers embedded SAE reporting capabilities directly within leading Electronic Data Capture (EDC) platforms, SDC provides an innovative alternative to traditional safety data collection processes.

icon-start-up-planning

For studies that do not require global pharmacovigilance services, our integrated eSAE solution enables:

  • End-to-end safety data collection and reporting directly within iMedNet® and Medidata Rave®.
  • Reduced site burden by automatically leveraging adverse event data already entered into case report forms, eliminating duplicate data entry.
  • Integrated management of SAEs, UADEs, and AESIs through validated workflows that improve efficiency and data quality.
  • Automated SUSAR reporting alerts to help ensure timely safety monitoring and regulatory compliance.
  • Real-time notifications to designated safety team members for rapid assessment and action.

By embedding safety workflows directly into existing study systems, SDC helps sponsors improve operational efficiency while maintaining comprehensive oversight of critical safety information.

For studies that do not require global pharmacovigilance services, our integrated eSAE solution enables:

PV with SafetyEasy®

For clinical trials requiring comprehensive global safety reporting and surveillance, SDC offers SafetyEasy®—a proven Multivigilance management suite used across drug, device, and cosmetic studies.

SafetyEasy® supports full compliance with FDA, EMA, and MHRA requirements and adapts to evolving global pharmacovigilance regulations. With an intuitive user interface, the platform streamlines adverse event data capture, coding, and regulatory submissions.

safety_easy pharmacovigilence offered by SDC - Statistics & Data Corporation

Key Features & Benefits of SafetyEasy®

Smart MedDRA Coding

Accelerate adverse event classification with intelligent coding suggestions that improve consistency, reduce manual effort, and support accurate safety reporting.
Smart MedDRA Coding

Automated Narrative Generation

Create high-quality safety narratives quickly and efficiently, helping teams reduce administrative workload while maintaining reporting quality.
Automated Narrative Generation

Global Regulatory Submission Support

Generate and export reports in multiple regulatory formats, including MedWatch, CIOMS, MedDev, and other internationally recognized submission standards.
Global Regulatory Submission Support

Evolving Compliance Management

Stay aligned with changing FDA, EMA, MHRA, and global pharmacovigilance requirements through a platform designed to support ongoing regulatory compliance.
Evolving Compliance Management

Cross-Modality Flexibility

Support pharmacovigilance activities across a broad range of clinical programs, including pharmaceuticals, medical devices, and cosmetic products.
Cross-Modality Flexibility

Streamlined Safety Operations

Improve productivity through centralized case management, faster processing workflows, and greater visibility into safety activities across studies.
Streamlined Safety Operations

Enhanced Accuracy and Efficiency

Reduce manual data handling, minimize errors, and accelerate safety reporting through integrated, technology-enabled workflows.
Enhanced Accuracy and Efficiency

Partner with SDC for Confident Safety Oversight & Technology

Whether you need embedded SAE reporting within your EDC or a comprehensive global pharmacovigilance solution, SDC delivers the expertise, technology, and operational excellence required to protect patient safety and maintain regulatory compliance.

EMPOWER YOUR CLINICAL DECISIONS

Ready to Strengthen Your Pharmacovigilance Strategy?

Contact SDC today to learn how our safety experts and SafetyEasy® platform can help streamline safety operations, improve compliance, and empower better clinical decisions.