ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

Signals Clinical streamlines clinical data workflows, reducing the time spent preparing data for analytics. Its comprehensive platform enables the rapid delivery of clinical insights that inform both clinical and operational study decisions.

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.

Experience higher data quality, retention and participant compliance by providing a truly engaging experience from data submission to reminders, appointment management, telemedicine and more -- from the phone, tablet, or desktop.

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.

Locate sensitive information and unusual behaviors, encrypt files, and prevent data theft.

Intelligently manage the entire file lifecycle, from creation and active usage to archival and removal.

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.