
Biostatistics and Statistical Programming
Cmed offers a complete range of biostatistical and statistical programming services.
Many members of our biostatistics and programming team have pharma company experience ensuring a client-oriented approach to their activities. This includes a great understanding for flexibility and the need for a timely and quality product. A specially developed global statistical programming environment supports our efficient processes and, more importantly, our experienced teams.
How does this benefit you?
Cmed’s biostatisticians’ and statistical programmers’ knowledge and expertise are combined as they work together on all projects. Meaning clear presentation and maximised accuracy are assured.
Our experience and knowledge ranges from Phase I to Phase IV, across a comprehensive portfolio of therapeutic areas, most notably in the oncology area. We’ve also gained significant expertise in bioequivalence, drug-drug interaction and pharmacodynamic studies.
Timaeus, our own groundbreaking iDAM technology, allows us to offer a full service for the design, conduct, analysis and reporting of adaptive trial design studies. These capabilities are also relevant to all study designs that require rapid data access to help decision-making. We also use a regulatory-compliant, global, version-controlled programming environment using SAS® version 9.
Central to our success is our commitment to delivering high quality products at all times, coupled with the need to maintain the flexibility to respond to changes in requirements. This is supported through:
- Indication specific training provided to all staff allocated to new projects
- Operating to specifically defined standards, set from start to completion – including a QC plan for each project and programming QC via independent coding
- Clear analysis plans, analysis dataset specifications and full table, listing and figure shells
- Careful and frequent project and resource planning
- Pre-load work – programmed outputs produced in test run(s) for review well ahead of database lock
Biostatistics & Statistical Programming Services:
- Protocol development
- CRF/eCRF development
- Sample size calculations
- Randomization generation
- Statistical consultancy
- Statistical analysis
- Statistical management of adaptive design studies
- Analysis, tables, figures and listings programming
- Statistical reporting
- Overall summaries of safety and efficiency
- DSMB support
- FDA, EMEA experience