Biometry
Biometry Solutions
Translate your clinical practice into data-driven conclusions
Innovation in data collection and analysis is crucial to improve the clinical trial experience of all stakeholders.
The quality and integrity of the data collected during your clinical trial is key to the success of your product development project.
At Eurofins Optimed we are fully equipped to provide results-driven services underpinned by the highest traceability and transparency in order to successfully complete even the most complex data integrations, while meeting the strictest timelines
One-stop Biometry shop
Our in-house Biometry services span the entire continuum of data management, biostatistics and the writing of the final study report.
We customize, harmonize, visualize and interrogate your data in order to further enhance the coherency and robustness of your study, which will ultimately support and accelerate its regulatory submission and approval.
Our clinical Data Management professionals, statisticians and medical writers work in the same office, which allows the perfect synergy and engagement throughout the entire study.
Security: your data is securely stored and processed at all times in compliance with 21 CFR Part 11 requirements. It is saved on a daily basis on our secure internal server (NAS) and weekly on an external data tape drive.
Technology
Our integrated digital clinical development platform (LifeSphere Clinical) provides a single source of truth, enabling efficient data management, improved data quality and standardization, on-demand data extraction, ad-hoc reporting and the ability to efficiently gather business intelligence.
Click here to download LifeSphere’s EDC factsheet
Data Management
From database design and building, through data cleaning and query resolution, to database lock and archiving, we undertake all stages of your data management activities, while ensuring robust, secure and cost-efficient collection and delivery of accurate data in a customized output format.
- Data management plan
- Completion guidelines
- Database design, building and Implementation
- Customized programming
- CRF design and development/ annotation and review (electronic, paper or hybrid)
- Data validation plan
- Edit checks specification, programming and validation.
- Query management
- Data entry/review/cleaning/quality control
- External data set-up, load and reconciliation
- Medical coding (MedDRA and WHO Drug)
- SAE management and reconciliation
- Definition and programming of protocol deviations
- Data management report
- Database lock
- Data export and transfer
- Data Archival
- Web based site training
- User Acceptante testing (UAT)
- Real-time metrics viewing and reporting
- CDISC (SDTM and ADaM) approved formats
Biostatistics
We provide guidance on all aspects of the design, sample size estimation and conduct of trials to ensure seamless integration and interpretation of statistical elements into the reporting of clinical data.
Our experts apply scientific principles and knowledge of therapeutic indications to ensure that your study design, conduct or data collection are statistically consistent and meet all the regulatory requirements.
- Sample Size calculation
- Protocol and CRF review
- Modeling and simulation
- Statistical analyses plan (SAS®)
- Tables, listings and graphs (TLGs) programming
- Validation of programs
- TLGs printing
- Statistical report writing
- Epidemiological clinical report
- PK/PD analysis
- QT/QTc analysis
- Interim analyses
- Built-in system of randomization (list upload or IWRS) and supply management
- Module for planning and conducting the inventory of drugs and materials for a trial Agsupply
Final study report
Your study report must be clear, concise, scientifically accurate and fully compliant with regulations, and industry best practices.
We translate your scientific research and clinical practice into data-driven conclusions in order to demonstrate the therapeutic potential of your product and to improve patient safety.
Your final study report, including hyperlinks and text research will be fully compliant with:
- ICH E3, ICHE3 Q&As guidelines (report’s structure and content)
- eCTD ICH M4 R4 standards (synopsis, the text of the report and each appendix as an individual document)
- FDA recommendations (PDF Technical Specifications V4.1, Sept.2016)
