The Biometry Department of Eurofins Optimed ensures suitable management of your data, from the initiation of your project to the final report. Depending on the needs of your project, Eurofins Optimed can provide full or “à la carte” services.
The data of your study is managed by an experienced team and the system used LIFESPHERE® enables Eurofins Optimed to manage all your clinical data in a single system which is 21 CFR part 11 compliant, improving accuracy, visibility and data integrity.
Using the LifeSphereEDC®, we offer a complete e-solution for electronic data capture, in a secure environment and in compliance with international rules and guidelines (21 CFR part 11 compliance).
Our expert knowledge of the data management process also gives Eurofins Optimed the possibility to manage external data : central lab, e-diaries, coding data (MedDRA, WHO-Drug, …).
A dedicated team of senior statisticians for your project:
- Methodological advice & support for your study design
- Statistical reports according to ICH guidelines
- PK/PD analysis
- QT/QTc analysis
Using in-house or sponsor document templates, Eurofins Optimed covers the following areas:
In the preparation phase:
- Synopsis / Protocol (clinical trial, non-interventional studies or Clinical Investigational Plan for medical devices)
- Informed Consent form / Patient Information
- Case Report Form / Patient Diary
During or after the study:
- Clinical study report in line with ICH E3
- CDISC format (SDTM & ADaM)
- (Electronic) Common Technical Document (eCTD)
- Interim efficacy report / Safety reports
- Participation in Abstracts / Posters / Publications