“Data Management” is a very generic and overused term in the industry. It means different things to different companies. At Innoventz, data management goes beyond simply following up on queries in the EDC system. It means following up on excessive queries from a particular site or CRF and determining their root cause(s). For example, excessive queries from a particular CRF could indicate poor training or a breakdown in a fundamental assumption; in either case the issue should be addressed immediately, so as not to further compromise the quality of the data.

Our comprehensive data management services include:

• In-depth protocol review
• CRF design and standardization
• Data management plan and SOP development
• Clinical monitoring plan development
• Training on EDC platform, study-specific material, and site set-up and training
• Query management and analysis
• Adverse and Serious Adverse Event reconciliation
• Coding of Concomitant Medications and Adverse Events
• Analysis and reporting for internal data review meetings, Interim Analysis, Annual and Final FDA Submissions, and Risk Assessment
• Aggregation of protocol deviations for trending analysis
• Process optimization and re-engineering analysis
• Project management

Get started today by contacting Innoventz.

Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.