Introducing Rave 5.6—EDC with Broad CDMS
With the new release of Rave, Medidata Solutions provides an easy-to-use, easy-to-learn solution that delivers both electronic data capture (EDC) and clinical data management systems (CDMS) functionality in a single, scalable system. Medidata Rave 5.6 enhances the role of the entire study team, allowing research sponsors to increase efficiency, reduce risk and scale to handle any size or phase study by:
- Improving efficiency of study build and life cycle management
- Improving productivity in data capture and management, and monitoring
- Improving ease and flexibility of reporting.
CDISC ODM V1.2 Certification—Medidata Rave is the first and only clinical trial technology solution to become certified on all eight available CDISC ODM cases for complete interoperability in importing and exporting clinical study data and meta-data.
Dynamic Tabulation Engine—Empowers clinical researchers to flexibly collate, extract and format real-time clinical data in a consistent manner across studies for analyses, reporting and submissions internally through Rave or with powerful third party tools such as Business Objects®, J-Review®, and SAS®. Benchmarked against SDTM. Replaces the need for separate ETL tool.
Global Library—Speeds design of multiple studies through the reuse of previous studies or study elements, and allows for the secure and controlled establishment of standards libraries that can be leveraged across enterprise wide e-clinical deployments. Guided by a Global Library Wizard, study designers can easily select and reuse components ranging from edit checks to entire forms and visit structures.
Architect Loader—Allows for study designs to be edited, moved and stored offline, providing a complete automatically-generated study specification and improving communication and collaboration between organizations within a sponsor, or between sponsors and outsourcing partners. Also uploads study-design metadata from any CDISC ODM compliant system, such as the Medidata Designer® protocol authoring tool.
Amendment Manager Enhancements—Extends Rave's capability to efficiently manage mid-study changes with analysis tools to determine differences between study versions, and to efficiently deploy selected changes, including automatic scheduling of migrations.
Lab Loader—Exports and imports lab set-up data in Excel-readable XML format for offline documentation and maintenance, and consistent lab-settings across multiple studies.
CRF Attachments—Allows storage of images, documents or other digital files as part of study records with the same level of security and compliance as other clinical data.
SAS On Demand—Scheduled email or FTP export for SAS analysis of data-sets, leveraging Rave's granular security permissions.
Local Lab Enhancements—Builds on Rave's start-of-the-art laboratory module by allowing simple referencing of sponsor-chosen ranges for local laboratory results.
Data Clarification Forms—Generates and tracks data clarification forms (DCF) for sponsors leveraging Rave's double data entry (DDE) capabilities.
Report Localization—Extends Rave's multilingual capabilities to reports, leveraging Rave's flexibility to present all information in the user's language of choice.