Bioforum the Data Masters
Bioforum is a data-focused clinical research services provider that offers integrated data management, biostatistics, statistical programming, medical writing and biometrics project management for pharmaceutical, biotech and medical device sponsors. The company provides EDC and analytics implementation, SDTM/ADaM conversion and regulatory submission support, risk-based data oversight, and functional service provider (FSP) engagements aimed at reducing manual work and improving data quality for regulatory dossiers and trial decision-making.
Industries
Nr. of Employees
medium (51-250)
Bioforum the Data Masters
Products
Analytics and visualization platform
A clinical data analytics and visualization platform that integrates raw data and metadata to provide interactive dashboards and operational views.
SDTM conversion platform
A platform for converting raw clinical data to SDTM submission-ready packages, including automation and machine-learning-assisted mapping recommendations.
CDISC validation tool
A CDISC CORE-based validation tool for checking compliance of study data with CDISC standards.
Risk and validation management tool
A toolset for risk management and validation oversight supporting data integrity and compliance activities.
Analytics and visualization platform
A clinical data analytics and visualization platform that integrates raw data and metadata to provide interactive dashboards and operational views.
SDTM conversion platform
A platform for converting raw clinical data to SDTM submission-ready packages, including automation and machine-learning-assisted mapping recommendations.
CDISC validation tool
A CDISC CORE-based validation tool for checking compliance of study data with CDISC standards.
Risk and validation management tool
A toolset for risk management and validation oversight supporting data integrity and compliance activities.
Services
Database builds, data review and reconciliation, medical coding, query management and data cleaning for clinical trials.
Production of TFLs, SDTM/ADaM dataset generation and preparation of submission-ready data packages.
Statistical analysis plan development, protocol statistical review, optimized trial design and support for regulatory submissions.
Preparation and QC of protocols, clinical study reports, investigator brochures, manuscripts and eCTD-ready materials.
Project initiation, risk management, monitoring and control, and quality assurance for biometrics activities.
Provide embedded biometrics teams that operate under sponsor SOPs to augment internal capacity without direct hiring.
Database builds, data review and reconciliation, medical coding, query management and data cleaning for clinical trials.
Production of TFLs, SDTM/ADaM dataset generation and preparation of submission-ready data packages.
Statistical analysis plan development, protocol statistical review, optimized trial design and support for regulatory submissions.
Preparation and QC of protocols, clinical study reports, investigator brochures, manuscripts and eCTD-ready materials.
Project initiation, risk management, monitoring and control, and quality assurance for biometrics activities.
Provide embedded biometrics teams that operate under sponsor SOPs to augment internal capacity without direct hiring.
Expertise Areas
- Clinical data management
- Biostatistics and statistical programming
- Medical writing and regulatory documentation
- Clinical data analytics and visualization
Key Technologies
- CDISC SDTM/ADaM
- Controlled terminology and submission packaging
- Electronic data capture (EDC) systems
- Machine learning for data mapping
News & Updates
Participation as exhibitor, sponsor or attendee at regional industry conferences and meetings.
Discussion of clinical data oversight and the role of monitoring trends, KPIs and KRIs in ensuring data integrity for trials.
Overview of applications of artificial intelligence in clinical development and decision making.
White paper and discussion on applying machine learning to assist SDTM source-to-target mapping and improve conversion workflows.
Participation as exhibitor, sponsor or attendee at regional industry conferences and meetings.
Discussion of clinical data oversight and the role of monitoring trends, KPIs and KRIs in ensuring data integrity for trials.
Overview of applications of artificial intelligence in clinical development and decision making.
White paper and discussion on applying machine learning to assist SDTM source-to-target mapping and improve conversion workflows.