With in-depth clinical and regulatory experience at every level of our Biostatistics team, Medpace understands the practical and scientific issues specific to your clinical data. From study inception to delivery of the Integrated Clinical Statistical Report, our skilled group of biostatisticians are involved at every phase of drug development – providing statistical programming and analysis to create a customized approach designed specifically to meet your project requirements.
Our experienced team of biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial efficiently and on time. Data analysis is performed using industry-standard SAS® software, ensuring that every phase of your trial is correctly focused for maximum results.
The Medpace Biostatistics team delivers
- Comprehensive data analysis plans, including sample size determinations, detailed descriptions of statistical methodologies, program specifications, generated randomization codes, and mock examples of all deliverables.
- Generation of customized programs thoroughly tested and validated according to documented procedures.
- Interpretation of study results and writing support for the preparation of study reports.
- Integrated efficacy and safety analysis for regulatory submissions, including electronic submissions.
- Adaptive design to help lower development costs and reduce time to market.
- Statistical support throughout – including post-Phase II and Pre-IND meeting support.