CENTRAL LABORATORIES WHITE PAPERS & ARTICLES

CENTRAL LABORATORIES APPLICATIONS & STUDIES

CENTRAL LABORATORIES PRODUCTS & SERVICES

Compliance, Collaboration, Control: Streamlining the Development Process.

Code and approve clinical trial data from any device and keep your safety and efficacy data clean, consistent, and ready for analysis.

Elevate Your Clinical Research Data Collection

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.

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.

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.

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.

Avance Clinical’s data management team has gained a world-class reputation for accuracy, precision, and quality of their biostatistics and pharmacokinetic (PK) analysis.