Biostatistical Services for Medical Device Manufacturers
Alquest employs a highly experienced cadre of medical device-focused professional biostatisticians. Our team members average over 15 years of experience in biostatistics.
Our services include:
- Statistical and analysis planning for trial protocols
- Sample size calculations for clinical trials
- Participation in FDA meetings and teleconferences focusing on statistical design or data analyses
- Collaboration with medical experts to extract meaningful clinical interpretations from data analyses for use in scientific papers or regulatory submissions
- Randomization scheduling
- Statistical analysis and preparation of statistical sections for reports, e.g. Creation and validation of datasets, tables and listings for clinical trials
- Perform audits of project management, data management and statistical group
- Report writing for regulatory submissions or other reporting requirements
- Audit preparation and support for bioresearch monitoring (BIMO)