SAKK Consulting services – Support for your clinical trials and registries
Do you have a good idea for a research project, but need support in planning and conducting it? Are you sometimes struggling to understand results presented at congresses or in manuscripts? Our experienced team is ready to support you! Our consulting services include statistics, data management and education.
Our expertise
- In depth experience with multi-centric Phase I, II and III clinical trials and registries in Oncology
- Experienced team of biostatisticians, statistical programmers, database developers and clinical data managers
- Teaching experience at University, University of applied Sciences, internal and external courses
- Statistical expertise at congresses (e.g. Chicago in the Mountains, ESMO in the Alps)
Statistics
Are you unsure how many patients are needed for your clinical trial?
Planning
- Statistical design
- Sample size calculation
- Randomization schemes
- Statistical input into protocols
- Statistical analysis plan
Analysis
- Interim analysis including presentations at IDMC meetings, if applicable
- Primary and final analysis
Reporting & Publications
- Clinical study reports
- Statistical input into publications, including tables and figures
Quality control
- Double-programming, code or result review
- Independent statistics for 3rd party trials (e.g. interim analyses including IDMC meetings)
Your contact
Data Management
Do you still collect the clinical data for your clinical trials or registry projects with the help of confusing Excel spreadsheets or Access databases? Do you struggle with the quality of clinical data collected for your clinical trials or registry projects? The SAKK Clinical Data Management supports you!
Professional, clearly arranged and well-structured electronic Case Report Forms in secuTrial®
- eCRF and database development
- Database testing and validation
- Database hosting
- Database and user administration
Project specific, GCP compliant data validation procedures
- Development of Data Validation Plans
- Programming of electronic edit checks in secuTrial® eCRFs
- Programming of complex data discrepancy checks in SAS®
- Data validation procedures incl. electronic query management
Your contact
Education
As e.g. Altman and Bland stated in their article in BMJ in 1995, with the appropriate title “Absence of evidence is not evidence of absence”, just because a p-value is not significant, that does not mean that there is no clinical relevance in a study finding. There are many possible reasons why a result may not be statistically significant, e.g. lack of statistical power. So do not conclude from a non-significant p-value, that there is no effect.
Our statistical education program
- Trainings on basic or advanced statistical topics
- General presentations or tailored to specific questions
- Short presentations (e.g. Oncolunches), longer workshops or lecture series
- Expertise at congresses
- Advice on interpretation of clinical trial results, e.g. statistical comments on conference presentations or manuscripts
Your contact