Safety & Pharmacovigilance Solutions | Streamlined Safety Reporting for Clinical Trials

The Critical Role of Pharmacovigilance in Clinical Research

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.

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
As the first CRO to offer embedded SAE reporting capabilities directly within leading Electronic Data Capture (EDC) platforms, SDC provides an innovative alternative to traditional safety data collection processes.

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.

Smart MedDRA Coding

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

Automated Narrative Generation

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

Global Regulatory Submission Support

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

Evolving Compliance Management

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

Cross-Modality Flexibility

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

Streamlined Safety Operations

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

Enhanced Accuracy and Efficiency

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

Empowering Safer, Smarter Through Integrated Pharmacovigilance

The Critical Role of Pharmacovigilance in Clinical Research

How SDC Experts Support Your Pharmacovigilance Program