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.

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.

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.

Today’s clinical researchers need precise, timely, and reliable solutions for managing huge amounts of diverse data. TrialKit AI is here to meet this demand.

Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.

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.

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.

Seamlessly integrated with Curebase’s ePRO/eCOA suite, our EDC enables hybrid and site-based studies that users will love and that streamline all of your data collection into a single, modern experience.