Our specialists offer innovative and cost-effective services of the highest quality. With our excellent expertise and as dedicated team players, we proactively support interdisciplinary study teams and contribute to the success of your studies with a high level of commitment. Working in compliance with industry standards and processing your projects according to internal company standard procedures are just as much a matter of course for us as the binding adherence to agreed milestones. We offer a complete service portfolio for your projects or individual services as required.
Ilka Strehlau Head of Clinical Data Management
Data management
Your study teams can rest assured: We give our best for your success. We impress with proven expertise, team spirit, and genuine enthusiasm for your project. As a result, you receive complete, consistent, reliable, and, above all, reproducible data of excellent quality at all times. We work in accordance with industry standards and move your projects forward with internal company standard procedures. It goes without saying that we adhere to agreed milestones. We have been a CDISC Gold member since 2012 and work according to the CDASH and SDTM standards.
Excellent services: We support you with these services
- Strategic advice on selecting the best e-clinical solutions for your project
- Application of good clinical data management practice throughout the project
- CRF design according to CDISC CDASH standard
- Database specifications according to in-house libraries (CDISC standard)
- Implementation of user-friendly eCRFs and other CDM systems
- Development of all essential DM documents for your successful project management and realisation
- Targeted data review and cleaning in close collaboration with the clinical team
- Coding of medical terms according to MedDRA and WHO Drug Global
- Reconciliation of safety data with our customers' database
- Integration and validation of external data such as laboratory data
- Quality checks
- CDISC - SDTM mapping
- Meaningful status reports and metrics
- Electronic data transfers during the project course and for archiving
Achieve complete, consistent, reliable and, above all, reproducible data of excellent quality with the guidance of our competent and experienced data management team.
Contact: dm [at] x-act-cologne.com
Andreas FichtnerHead of Biostatistics
Biostatistics
From the planning and execution of the statistical analysis to the interpretation of the results to the report and presentation - our biostatisticians bring their years of experience to your study. Experienced and committed. We think about your project from the end. This is how we ensure that our analyses answer your questions. We translate your scientific question into an adequate and operationalisable plan.
Detailed: We support you with these services
- Study design and sample size determination
- Statistical sections in clinical trial protocols
- Statistical analysis plans
- Randomisation lists
- Statistical programming using SAS
- CDISC - ADaM Mapping
- Quality review and assessment of the study data and the planned statistical analysis methods
- Data review meetings
- Interim and final statistical analyses
- iDMC / DSMB Meeting support (blinded or unblinded)
- Cross-study analyses e.g. DSUR, PBRER
- Meta-analyses, preparation of historical studies
- Biostatistical reports
- Statistical sections in clinical study reports
- Support in the presentation of results in publications
- Study data in submission ready CDISC standards
We ensure high-quality and timely results. In doing so, we adhere to valid quality standards such as "Good Clinical Practice" (GCP).
Contact: bs [at] x-act-cologne.com
Kornelia Höschen Head of Quality Management
Quality
We ensure high quality standards in all processes, keep our experts' knowledge up to date, continuously develop ourselves further and always strive to improve. In doing so, we always have your individual wishes in mind. We reliably reconcile your study-specific requirements with the legal and regulatory requirements. Naturally, in excellent quality. If required, we can on board experienced external consultants for your project.
Always supportive: the services of our QM team
- Development of Standard operating procedures (SOPs) for the specialist departments
- Creation and maintenance of SOPs for legal and regulatory requirements
- Customised onboarding of new employees
- Regular feedback meetings
- In-house training and further training from external providers
- Participation in congresses
- Audits to monitor and optimise internal workflows and the associated documentation
- by our customers or external consultants
- Comprehensive and risk-based qualification and auditing of external vendors
- CAPA management for continuous quality assurance and process optimisation
- including root cause analysis and risk assessment
Our QM team goes above and beyond every day. And of course, we are happy to have this certified: Through audits carried out by our customers, by external consultants, or, as in 2023, by the BVMA for the third time!
Contact: qm [at] x-act-cologne.com