Turning Data into Insights

At Worldwide Flex, we understand that clean data is the foundation of successful analyses. We are an accredited Medidata Partner and certified study builders in multiple platforms.

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.

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.

Developing a therapy for a rare or ultra-rare disease is life-changing work with unique challenges. Examine how natural history data is being used to inform the clinical development process.

Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.

Zelta’s EDC has been used in more than 4,000 studies from startup to submission, across all phases, including over 500 phase 3c trials and 23 therapeutic areas.

Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services and statistical reports are customized and designed specifically to meet your project requirements.

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.