Mainanalytics
mainanalytics is a company specializing in biometrical services, clinical data analysis, and regulatory support for pharmaceutical and biotech companies. With a team of 90 professionals, they focus on high-quality services in biostatistics, data standards, clinical data management, and regulatory submission support, aiming to advance medical research and improve patient well-being. They are committed to progress, innovation, and international collaboration, supporting global projects and engaging in industry conferences and workshops.
Industries
Nr. of Employees
small (1-50)
Mainanalytics
Services
Statistical design and analysis services for pre-clinical and clinical studies, development and validation of analysis datasets and outputs, interim/DMC analyses and integrated summaries.
Implementation and consultancy for CDISC standards (SDTM, ADaM, CDASH, define-xml), legacy data conversion to standard formats and standardization planning.
CRF design, EDC setup (including edit checks and UAT), test data generation, query management, electronic data transfers and database lock support.
Preparation of submission-ready datasets and deliverables for regulatory agencies, participation in responses to authority requests and support for advisory committee interactions.
De-identification of clinical datasets and anonymization of clinical images to support compliant data sharing and transparency initiatives.
Workshops and support for open-source tools and languages used in clinical analytics and data science, including training for standards-related tooling and programming skills.
Statistical design and analysis services for pre-clinical and clinical studies, development and validation of analysis datasets and outputs, interim/DMC analyses and integrated summaries.
Implementation and consultancy for CDISC standards (SDTM, ADaM, CDASH, define-xml), legacy data conversion to standard formats and standardization planning.
CRF design, EDC setup (including edit checks and UAT), test data generation, query management, electronic data transfers and database lock support.
Preparation of submission-ready datasets and deliverables for regulatory agencies, participation in responses to authority requests and support for advisory committee interactions.
De-identification of clinical datasets and anonymization of clinical images to support compliant data sharing and transparency initiatives.
Workshops and support for open-source tools and languages used in clinical analytics and data science, including training for standards-related tooling and programming skills.
Expertise Areas
- Biostatistics and statistical programming
- Clinical data management
- Clinical data standards implementation (CDISC)
- Regulatory submission support and eCTD preparation
Key Technologies
- Statistical programming languages (R, SAS, Python, Julia)
- Data query and scripting (SQL, JSON)
- Version control (Git)
- Clinical data standards (SDTM, ADaM, CDASH, define-xml)
News & Updates
Participation of colleagues at the German CDISC User Group Meeting, with talks on CDISC eTFL portal and FDA safety tables.
Participation in the PHUSE Single Day Event in Frankfurt, focusing on development of clinical trials and innovation.
Celebration of fasting traditions across religions, promoting diversity and reflection.
Participation and presentations on CDISC standards and FDA safety tables in Dreieich.
Co-organization of a virtual workshop exploring future opportunities in the pharmaceutical industry.
Participation in the EFSPI workshop with insights on Health Technology Assessment.
Participation of colleagues at the German CDISC User Group Meeting, with talks on CDISC eTFL portal and FDA safety tables.
Participation in the PHUSE Single Day Event in Frankfurt, focusing on development of clinical trials and innovation.
Celebration of fasting traditions across religions, promoting diversity and reflection.
Participation and presentations on CDISC standards and FDA safety tables in Dreieich.
Co-organization of a virtual workshop exploring future opportunities in the pharmaceutical industry.
Participation in the EFSPI workshop with insights on Health Technology Assessment.