“Thank you for all your hard work on this study! You are a great data manager - the proof was in our audit that shows your attention to detail and well-trained staff. THANK YOU, THANK YOU, THANK YOU!”
How We Do Data Management at Innovative Analytics
IA is recognized as a Society for Clinical Data Management CCDM® Industry Partner (www.scdm.org) and will provide an SCDM® certified data manager as the lead or overseeing DM for the life of the project. We are able to develop iMedNet databases in house, which often results in a smoother study process. iMednet is a fully integrated, cloud based, one login role-based system. (http://www.mednetstudy.com) Alternatively, we are able to work with any sponsor preferred eCRF provider and have supported multiple EDC systems, including Medidata Rave, DataTrack, IBM Clinical Development, Protocol First, Inform, and others.
IA clients can be confident that their data are managed by qualified professionals who are utilizing best industry principles and practices. Best in class practices include starting eCRF design from CDASH and CDISC based eCRF templates, involving the statistician and sponsor team members early in the review process, working with clients to find efficiencies based on study similarities, and performing proactive data QC/QA well ahead of data close. Our Clinical Data Managers apply exceptional judgment to resolve troublesome data cleaning issues. Our working processes result in data that are appropriately documented and qualified for regulatory inspection.
The IA data manager has oversight responsibility for all data collection, cleaning, and storage, and works closely with the statistician and database developers to ensure that the project objectives relating to the clinical database are met on time and that the integrity of the clinical database is maintained. The data manager will be supported by the database developer, data entry technician, medical coding technician, query programmer, output programmer, and Quality Control reviewers. Database lock is accomplished with timelines established by the sponsor, site monitors, and sites. IA has considerable experience in expediting database lock.
Innovative Analytics Works for You
Our client had a late FDA change but still wanted to meet the seasonal allergic rhinitis season or face major delay. Innovative Analytics accelerated the necessary data base design to accommodate the start of the study and implemented a ‘continuous’ review of study start materials.
Overview of Services
Innovative Analytics offers the following Data Management Services:
Clinical Data Management System Study Definition (SAS dataset structure)
eCRF Design, Development, QC and Execution
Assembly and production of data entry system
iMedNet inhouse build
Able to work in any sponsor preferred system; recent experience with:
Rave
Inform
DataTrack
IBM Clinical Development
Protocol First
Data Cleaning and Query Management
Data Coding
Data Management Plan
Database Lock and Unlock
Training of users
Help desk support
Login CDMS IDs
Database Definition (SAS dataset structure)
Database exports to EXCEL Database exports to SAS
Real time access to data via MS SharePoint
