Services
Althica supports its customers with the following capabilities. Note
that list is not exhaustive, if you have in mind something specific,
please let us know.
We have the required experience to know when
to commit and when not, as we do care first on your satisfaction for a
sustainable collaboration.
Should we work together, be
sure that we will complete it successfully with the best quality delivered in time.
-
All - clinical
project - Clinical
trial - Scientific
communication - CDISC
expertise - Consulting/
Training - Processes/
Systems
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Quote
Project leadership (biotech/start-up)
- Be sponsor representative- Coordinate biometry activities
- Set-up internal biostatistics capabilities
- Support junior team in submission prep.
IT for Health Research
- GCP/GLP systems validation- Biobank, eHealth and LIMS services
- Samples Management System
- System architecture/Data Exchange Interfaces
- Healthcare Information Systems
- Data transfer security
- Audit and process documentation
Clinical data management
- CRF design (EDC/Paper)- Database design
- Data cleaning
- Electronic Data Integration
- Data Management and Validation Plan
- Data Management Systems Audit
Consulting and Training
- Bayesian methods- Study designs
- Dose escalation studies
- Psychometric instruments validation
- Health Economics/Outcome Research
CDISC implementation
- Data conversion- Auditing
- Submission Datasets validation
- Training
Scientific communication
- Coordination of project- Statistical analysis plan
- Tables and figures programming
- Dynamic data visualization for web
- Collaboration with authors
Project/Program level
- Due dilligence- Clinical development plan
- Preparation of briefing documents
- Meeting with health authorities
- Integrated summary (ISE/SCE, ISS/SCS)
Statistical programming
- Development of analysis code (SAS, R, ..)- Documentation
- Project management
- CDISC compliant
Independent statistical center
- Independent statistician- iDMC analyses
- Interim Analysis
- Critical review of analyses/reports
Protocol development
- Design (fixed and adaptive)- Sample size computation
- Writing
- Amendments
Statistical Analysis Plans
- Analysis specifications (methods)- Estimands
- Handling of missing data
- Statistical outputs layout
- Analysis code for inferential analysis