PRODUCTS->EDC

Trial Management EDC features:

Easy-to-use design and layout tool lets you create CRFs to capture virtually any type of data, from simple blood pressure to free-form quality of life questions.

A wide variety of validation rules can be assigned to each data field, ensuring that data is entered correctly. You can set ranges of acceptable values or whether data is required within a field. You can even set multiple rules for a single field and validate field values against other fields.

Field grouping allows multiple data fields to represent a single data point. For example, three checkboxes (Yes, No, Unsure) can work together to represent a single answer to a question.

Users can enter clinical data into CRFs while tracking patient visits. This creates a single-point-of-entry for clinical data and study project and financial management information.

Enter adverse events and track their properties, including the type of AE, the date and time of the AE, whether it was serious, notes, and more.

CRFs and AEs can be submitted electronically for review. Study monitors can then flag problems or issue queries that clinical staff can respond to online. All interactions and field modifications are fully audited.

Study Manager EDC complies with the Code of Federal Regulations (CFR) Section 21 Part 11 and fully satisfies federal guidelines for clinical data entry and reporting.