Welcome to mainanalytics
Your CRO for Biometrical Services
Services
Biostatistics & Statistical Programming
- Pre-Clinical Projects
- Clinical Studies (Phase I – IV)
- Non-Interventional Studies
- Animal Health Projects
- Interim, DMC, and Final Analyses
- iDMC Support
- Data Integration and Integrated Summaries
- Periodic Safety Updates
- Exploratory Data Analysis
- Data Visualization
- Biomarker Analysis
- Publication Support
- Registry Support
- Statistical Consultancy
Data Standards
- Implementation of CDISC Standards (CDASH, SDTM, ADaM, Define-XML)
- CDISC Consultancy
- Customer Tailored Implementation of CDISC Standards
- Legacy Data Conversions
- P21 Expertise
- Trainings and Workshops
- CDISC Authorized Trainer (Newcomers, ADaM, Define-XML)
- Health Level 7 Standards Organization (HL7)
- Fast Healthcare Interoperability Resource (FIHR)
- Observational Medical Outcomes Partnership (OMOP)
Clinical Data Management
- CRF Design and Review
- EDC Setup (incl. Edit Checks and UAT)
- Test Data Generation
- Data Quality Surveillance
- Query Management
- Electronic Data Transfers
Regulatory Submission Support
- Preparation of eCTD Deliverables to FDA and PMDA including
– aCRF, SDTM, define.xml, cSDRG
– ADaM, define.xml, ADRG - BIMO related eCTD Deliverables
- Support of eCTD Deliverables to NMPA
- Participation in interdisciplinary teams involved in answering Health Authority Requests from EMA, FDA, PMDA and other agencies across the globe
- Support and attendance of FDA advisory committees
- Study Data Standardization Plan (SDSP)
- Compliance Review
- Health Technology Assessments
Data Transparency
- Data De-Identification
- Clinical Image Anonymisation
Open Source
- R, Python, JSON, JULIA
- Git
- Trainings and Workshops
Information Security
- CyberRisikoCheck
- Integrated Management Systems
- CQI/IRCA certified Lead/Auditor ISO 27001
- Consultancy and Audits
Outstanding quality
We are a team of 90 highly-motivated professionals.
We offer comprehensive expertise in all aspects of our services.
teamwork
flexibility
timeliness
accuracy