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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

  • 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

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