Navigating drug safety in the era of innovation-driven medicine

The focus on drug safety and pharmacovigilance has never been more intense. Patient safety remains paramount throughout a product's lifecycle, even as sponsors and marketing authorization holders (MAHs) face increasing complexity in managing safety data. This complexity stems from huge volumes of data generated from scores of diverse sources, much of it rapidly expanding unstructured data. Innovation-driven medicine is a key factor. These dynamics are reshaping the landscape of drug safety, presenting both challenges and opportunities for innovation in pharmacovigilance practices.

Ergomed’s Meticulous Risk-Based Quality Management Approach

As a pioneer in providing comprehensive support for your clinical research, Ergomed champions an innovative Risk-Based Quality Management (RBQM) approach. This forward-thinking strategy ensures the highest patient safety standards, regulatory compliance, and data reliability. Ergomed’s proactive approach to managing clinical trials tackles clinical research complexity head-on.

Read about Philips New Standard in Sleep & Scratching Measurement.

The Australian Advantage is about saving time and minimizing costs while generating internationally accepted data in preparation for the next Phase.

Speed without shortcuts: AI in clinical development

Our vision is to develop AI solutions that enable faster delivery of new medicines to patients.

AI in Clinical Development is at the core of Parexel’s approach to accelerating first-time quality and milestone delivery through our strategic operating model, Parexel Precision Pathway. We’re committed to the development of innovative, high-value use cases for AI in clinical trials. AI empowers our people at critical decision points and our AI investments prioritize process optimizations that:

1. Simplify complex tasks to accelerate timelines
2. Apply insights with agility to enable better decision-making
3. Enhance data handling to drive first time quality through content generation and workflow automation.

It’s about time.
Modern ePRO/eCOA.
Solved.

Don’t wait a lifetime to launch a study that’s just “good enough”. Build and design a data collection experience that patients and sites will love to use.

Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

Locate and classify files quickly and automate reporting.