X-act Cologne
Independent, privately owned contract research organisation (CRO) based in Cologne, Germany, founded in 1994. The organisation focuses on clinical data management and biostatistics, providing end-to-end support from study planning to delivery of results for the life science industry. Offers services in data management, biostatistics, quality management and tailored project packages with emphasis on industry standards and reproducible data.
Industries
Nr. of Employees
small (1-50)
X-act Cologne
Cologne, North Rhine-Westphalia, Germany
Products
Datenmanagement
Professionelles klinisches Datenmanagement mit Kompetenz und smarten Technologien für valide Studienergebnisse.
Data management
Professional clinical data management services to pave the way for valid data with expertise and smart technologies.
Biostatistics
Scientific and operational biostatistics services to ensure project success with reliable study results.
Quality
Quality management and GCP quality assurance services delivering high quality standards for clinical studies.
Qualität
Qualitätssicherung und Qualitätsmanagement für klinische Studien.
Datenmanagement
Professionelles klinisches Datenmanagement mit Kompetenz und smarten Technologien für valide Studienergebnisse.
Data management
Professional clinical data management services to pave the way for valid data with expertise and smart technologies.
Biostatistics
Scientific and operational biostatistics services to ensure project success with reliable study results.
Quality
Quality management and GCP quality assurance services delivering high quality standards for clinical studies.
Qualität
Qualitätssicherung und Qualitätsmanagement für klinische Studien.
Services
Provider of end-to-end clinical data management services including CRF design, eCRF implementation, database specification, data cleaning, coding, quality checks and data transfers.
Statistical planning and execution services including study design, sample size calculation, statistical analysis plans, programming, interim and final analyses, and support for DSMB/iDMC activities.
Quality assurance services including SOP development and maintenance, audits, vendor qualification, CAPA management, and training to align projects with regulatory and contractual requirements.
Customised service packages combining data management, biostatistics and quality management to meet project-specific needs with transparent costing.
Provider of end-to-end clinical data management services including CRF design, eCRF implementation, database specification, data cleaning, coding, quality checks and data transfers.
Statistical planning and execution services including study design, sample size calculation, statistical analysis plans, programming, interim and final analyses, and support for DSMB/iDMC activities.
Quality assurance services including SOP development and maintenance, audits, vendor qualification, CAPA management, and training to align projects with regulatory and contractual requirements.
Customised service packages combining data management, biostatistics and quality management to meet project-specific needs with transparent costing.
Expertise Areas
- Clinical data management
- Biostatistics and statistical analysis
- CDISC data standards implementation
- Quality management and SOPs
Key Technologies
- CDISC standards (CDASH, SDTM, ADaM)
- eCRF and eClinical system implementation
- Statistical programming
- Medical terminology coding (MedDRA, WHO drug dictionary)
News & Updates
Company audited by BVMA in 2023 (third time) as part of quality assurance activities.
Member status indicating ongoing use and support of CDISC standards for clinical data.
Reported number of clinical studies conducted to date.
Company founded and established as an independent CRO in 1994.
Company audited by BVMA in 2023 (third time) as part of quality assurance activities.
Member status indicating ongoing use and support of CDISC standards for clinical data.
Reported number of clinical studies conducted to date.
Company founded and established as an independent CRO in 1994.