2KMM
Contract research and clinical IT services provider offering end-to-end clinical trial support (design, execution, operations), biostatistics and validated statistical programming, clinical data management with validated EDC/SaaS deployments, regulated software development and computerized system validation, data integrity and compliance services (including ALCOA++ guidance), and audit/quality management software implementations. Maintains ISO 9001 and ISO 27001 certifications and provides hosting and managed infrastructure for clinical IT.
Industries
Nr. of Employees
small (1-50)
Products
Validated EDC platform (SaaS) with mobile integration
A validated, next-generation electronic data capture platform delivered as SaaS with no-code eCRF setup, real-time data validation, API integration for eSource and RWD, support for mobile ePRO/eCOA apps and modules for randomization and monitoring.
Project and quality management platform with LMS and SOP management
Multi-module platform for project management, SOP/document repository, learning-management functionality, and competency tracking to support quality-oriented organizations.
Audit and compliance management platform
Software to plan and execute audits, manage non-conformities and corrective actions, schedule recurring audits and generate analytics for continuous improvement across manufacturing and services operations.
Validated EDC platform (SaaS) with mobile integration
A validated, next-generation electronic data capture platform delivered as SaaS with no-code eCRF setup, real-time data validation, API integration for eSource and RWD, support for mobile ePRO/eCOA apps and modules for randomization and monitoring.
Project and quality management platform with LMS and SOP management
Multi-module platform for project management, SOP/document repository, learning-management functionality, and competency tracking to support quality-oriented organizations.
Audit and compliance management platform
Software to plan and execute audits, manage non-conformities and corrective actions, schedule recurring audits and generate analytics for continuous improvement across manufacturing and services operations.
Services
Operational and scientific support for clinical trials and observational studies including protocol development, monitoring, data management, biostatistics, medical writing, safety monitoring and rescue study audits.
Regulated software development, testing and computerized system validation for clinical systems; SaaS deployment of validated EDC and mobile data-collection applications; managed hosting and infrastructure.
Implementation and customization of audit and compliance management platforms to digitize audits, manage deviations and corrective actions, and provide analytics for continuous improvement.
Operational and scientific support for clinical trials and observational studies including protocol development, monitoring, data management, biostatistics, medical writing, safety monitoring and rescue study audits.
Regulated software development, testing and computerized system validation for clinical systems; SaaS deployment of validated EDC and mobile data-collection applications; managed hosting and infrastructure.
Implementation and customization of audit and compliance management platforms to digitize audits, manage deviations and corrective actions, and provide analytics for continuous improvement.
Expertise Areas
- Clinical trial management and operations
- Biostatistics and statistical programming
- Clinical data management and validated EDC implementations
- Computerized system validation and regulatory compliance
Key Technologies
- Electronic data capture (EDC) platforms and eCRF builders
- No-code study design tooling
- APIs for eSource and real-world data integration
- Mobile applications for ePRO/eCOA and connected device telemetry
News & Updates
Exhibited services at the MEDICA international medical trade fair and engaged with potential partners.
Presented offerings related to certification and clinical evaluation of medical devices and participated in industry conference on clinical trials outsourcing.
Modernization of IT infrastructure and deployment of a high-availability server cluster to support clinical IT services.
Joined a regional automotive and advanced manufacturing cluster to promote audit and quality-management platform adoption across manufacturing sectors.
Listed among Polish companies in a sector report highlighting market trends and international partnership opportunities.
Exhibited at the OCT DACH conference as part of ongoing industry engagement activities.
Exhibited services at the MEDICA international medical trade fair and engaged with potential partners.
Presented offerings related to certification and clinical evaluation of medical devices and participated in industry conference on clinical trials outsourcing.
Modernization of IT infrastructure and deployment of a high-availability server cluster to support clinical IT services.
Joined a regional automotive and advanced manufacturing cluster to promote audit and quality-management platform adoption across manufacturing sectors.
Listed among Polish companies in a sector report highlighting market trends and international partnership opportunities.
Exhibited at the OCT DACH conference as part of ongoing industry engagement activities.