Our expertise in clinical trial management ranges from safety & efficacy studies to studies with new medical devices and therapies in various phases from feasibility to post-marketing.
The e-capture.net platform features an easy-to-use web interface, complex validation, advanced reporting and secure access throughout the whole application.
The platform is designed to be 21CFR, part 11 compliant.
Visit the e-capture website here.
edc2go allows you to easily set-up your eCRF by using available templates or by starting from scratch. Create your own views by adding your logo and by adapting color scheme to your wishes.
Sign up today and enjoy a 30-day free trial.
Visit edc2go here.
core lab tracker
Transferring large image data sets has never been easier. Ensuring immediate and automated tracking, the central communication platform allows all parties to stay up-to-date. No installation is required at the sending or receiving site.
Visit core lab tracker here.
Data Management services include:
- Data Management Plan development
- Case Report Form (CRF) / eCRF design and review
- Data Validation specification (Data Validation Plan)
- Edit checks programming and testing
- Ongoing data review and query management
- Customized status reports / trackers
genae statisticians are experienced in the statistical analysis of clinical trial data in general and in advanced statistical analysis methods for power calculations, interim & final statistical analysis and stopping rules in specific. Our ability to link databases from the core lab with the trial databases results in an unsurpassed data pool for strategic, scientific and marketing decisions.
Medical coding of Adverse Events (MedDRA)
Reconciliation of Serious Adverse Events and other data
Senior Clinical Data Manager Medical Device Industry
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