mainanalytics GmbH
Real-world evidence, clinical development services and biomarker analysis.
What they do
- Testing & analysis
- Regulatory & quality
From their website
Company website
- Pre-Clinical Projects (opens in a new tab)
- Clinical Studies (Phase I – IV) (opens in a new tab)
- Animal Health Projects (opens in a new tab)
- Interim, DMC, and Final Analyses (opens in a new tab)
- iDMC Support (opens in a new tab)
- Data Integration and Integrated Summaries (opens in a new tab)
- Periodic Safety Updates (opens in a new tab)
- Exploratory Data Analysis (opens in a new tab)
- Data Visualization (opens in a new tab)
- Publication Support (opens in a new tab)
- Registry Support (opens in a new tab)
- Statistical Consultancy (opens in a new tab)
- CDISC Consultancy (opens in a new tab)
- Legacy Data Conversions (opens in a new tab)
- Trainings and Workshops (opens in a new tab)
- CRF Design and Review (opens in a new tab)
- EDC Setup (incl. Edit Checks and UAT) (opens in a new tab)
- Test Data Generation (opens in a new tab)
- Data Quality Surveillance (opens in a new tab)
- Query Management (opens in a new tab)
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Company website
- Electronic Data Transfers (opens in a new tab)
- Preparation of eCTD Deliverables (opens in a new tab)
- BIMO related eCTD Deliverables (opens in a new tab)
- Support of eCTD Deliverables to NMPA (opens in a new tab)
- Health Authority Requests (opens in a new tab)
- FDA advisory committees (opens in a new tab)
- Study Data Standardization Plan (opens in a new tab)
- Compliance Review (opens in a new tab)
- Health Technology Assessments (opens in a new tab)
- Data De-Identification (opens in a new tab)
- Clinical Image Anonymisation (opens in a new tab)
- CyberRisikoCheck (opens in a new tab)
- Information Security Consultancy (opens in a new tab)
- CDISC Standards (opens in a new tab)
- CDASH (opens in a new tab)
- SDTM (opens in a new tab)
- ADaM (opens in a new tab)
- Define-XML (opens in a new tab)
- P21 (opens in a new tab)
- Health Level 7 Standards (opens in a new tab)
- Fast Healthcare Interoperability Resource (opens in a new tab)
- Observational Medical Outcomes Partnership (opens in a new tab)
- R (opens in a new tab)
- Python (opens in a new tab)
- JSON (opens in a new tab)
- JULIA (opens in a new tab)
- Git (opens in a new tab)
- Data Standards (opens in a new tab)
- Data Transparency (opens in a new tab)
- Open Source (opens in a new tab)
- Information Security (opens in a new tab)
Cyber risiko check
- Cybersecurity risk review (opens in a new tab)
- Cybersecurity recommendations (opens in a new tab)
- Information discussion (opens in a new tab)
- Current-state assessment (opens in a new tab)
- Results report and risk score (opens in a new tab)
- Action recommendations (opens in a new tab)
- Din SPEC 27076 (opens in a new tab)
- IT infrastructure risk identification (opens in a new tab)
- Risk score creation (opens in a new tab)
- IT systems and networks (opens in a new tab)
- Backup process review (opens in a new tab)
- Patch process review (opens in a new tab)