EDC & Data Management

Our databases fulfill important baseline attributes while allowing for the specialized configuration required for analgesic report outputs, and are configured with the end goal in mind: appropriate calculation of analgesic primary and secondary endpoints. Data management services include:

• Analgesic database design
• Manual and automated data validation on entered data. Our review focuses on typical issues with pain trials, such as rescue medication versus pain intensity and typical analgesic adverse events.
• Medical coding
• Electronic Case Report Form (eCRF) design using an internal template library of pain CRFs for streamlined build approach
• Rapid EDC development, implementation and management
• CDISC Study Data Tabulation Model (SDTM)
• Conversion services
• Online access to the system
• Custom reports tailored to each individual trial
• Management of third-party data (e.g. lab, pharmacokinetics [PK])
• Data cleaning, including query management and report/listings review
• Standard set of reports tailored to pain trials
• Serious Adverse Event (SAE) reconciliation

When interim analysis is required, time is of the essence. Precise, well organized data output allows biostatisticians to efficiently access the information required by the interim analyses in a timely manner. We perform test exports and analyses of dummy, protocol-specific data well before interim analyses take place to ensure that any kinks can be ironed out prior to “crunch time.”