Larix Clinical Trials Planning and Management Services
Larix is a full-service CRO providing assistance in all aspects of clinical trials. With our extensive experience we help you plan and manage your trials, from trial design and trial management to feasibility, clinical monitoring, database design and data management, statistical analysis, medical writing, and pharmacovigilance.
Our full attention is on our customers’ goals within their projects and on their specific needs. This is achieved by constant focus on communication, pro-activity and quality, delivered on time.
Clinical research services for drug development and trial management
Our department of clinical research offers many years of experience in drug development and trial management. We provide expert services in all key areas of the drug development process, including:
- Overall planning of drug development, e.g. trial design and synopsis writing
- Pre-trial feasibility
- Clinical trial management, including protocol writing and ongoing trial management
- Clinical trial monitoring, including site selection and site initiation, ongoing monitoring, and site close-out
- Medical writing: writing of regulatory documents including clinical trial reports, synopsis and investigator’s brochure; and proof-reading and editing
- Medical advice / drug development advisors
We offer out-sourced consultants as well as providing services from the Larix premises.
Data management services for clinical trials
Our department of data management offers many years of experience in data management. We provide expert services in all key areas of the data management process, including:
- Input to trial protocol
- Data management plans
- CRF design and annotation
- Database design
- Validation planning and validation checks
- Query process
- Coding (adverse events, diseases and medication)
- Database release and transfer of data
- Final data management reports and delivery of all data to sponsors
Our data management services are based on the eDM system from Omnicomm. The system is fully 21CRF part 11 compliant and validated to relevant standards. We can also work with our sponsors’ own data management systems, e.g. Oracle Clinical.
Statistics services for clinical trials
Our department of statistics offers many years of experience in handling all statistical tasks, all the way from clinical pharmacology trials to pivotal phase III trials and beyond, including:
- Input to trial protocol and statistical analysis planning
- Choice of trial design and power calculations
- Statistical programming and validation
- Statistical analysis planning
- The actual statistical analyses
- Separate statistical reports or input to integrated reports
- Interim analyses and meta-analyses, etc.
- Statistical input to publications
- Statistical support to regulatory issues, meetings, etc.
We also offer statistical services in non-clinical areas such as research and development laboratories, as well as statistical process control and statistics in production facilities.
Larix is a CRO with a professional staff of around 20 people, located near Copenhagen. We have a range of customers from within and outside of this area. With more than eight years of experience we have provided services to small and large pharmaceutical companies and to a number of biotech and device companies. We are the largest CRO unit in Denmark in the areas of data management and statistics.