H2O Clinical

H2O biostatisticians have a broad knowledge base in all aspects of the clinical trial process, from the initial set-up, including study design, article research for sample size calculations, power analysis, and interim analysis, to analyzing, presenting and interpreting the final analysis results in the final stages of the study. Our international team consists of PhD- and MS-level statisticians that adhere to a single set of global standard operating procedures and have detailed and extensive knowledge of worldwide regulatory requirements. H2O experts map the analyses you’ll need before the study begins, then provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses.

We can leverage our vast statistical experience to design studies in a way that speeds submissions. H2O quality control processes will ensure accurate results. By applying standard templates and programs with customization as needed, we will provide efficient, high quality analyses for your project.

Biostatistics Services include:
Protocol development, including sample size and power calculations
Writing statistical sections of protocols
Writing statistical analysis plans
Randomization schedules
Statistical analyses using current methodologies
Interpretation and reporting of data for clinical trial reports and publications
Statistical and strategic consulting for product development
Interim analysis for early decision-making
Adaptive design consulting and simulation support
Serving as a data safety monitoring board member
Communication with regulatory agencies
Data mining
PK/PD analyses and modeling