Clinquest - Your Partner From Bench to Market

Data Management and Biostatistics

Clinquest offers full data management and biostatistics capabilities either in support of our clinical trials or as a separate service area. In addition to statistical analysis of clinical trial data, our biostatistics consultants provide expert and creative support for clinical trial design, sample size calculations, and the defense of statistical strategy at FDA meetings. Data management runs on either Clintrial or Oracle Clinical platforms and undergoes exhaustive quality control testing and quality assurance oversight from CRF design through database lock.

Our Data Management Practice provides clients with the following services:

CRF design Database design and construction Independent double data entry
Data validation and quality control
Coding to preferred dictionary, including MedDRA, WHODRUG, or a sponsor’s customized dictionary
Data reporting and export according to project requirements
Data management training and consultancy

Our Biostatistics Practice provides the following services:

Biostatistics strategic consulting for product development and regulatory defense
Sample size calculations Statistical Analysis Plan (SAP) development Clinical trial randomization
SAS programming of tables, listings, and figures
Statistical analysis and report preparation
DSMB support and participation
Integrated Summaries of Safety and Efficacy




		Data Management and Biostatistics Clinquest offers full data management and biostatistics capabilities either in support of our clinical trials or as a separate service area. In addition to statistical analysis of clinical trial data, our biostatistics consultants provide expert and creative support for clinical trial design, sample size calculations, and the defense of statistical strategy at FDA meetings. Data management runs on either Clintrial or Oracle Clinical platforms and undergoes exhaustive quality control testing and quality assurance oversight from CRF design through database lock. Our Data Management Practice provides clients with the following services: CRF design Database design and construction Independent double data entry Data validation and quality control Coding to preferred dictionary, including MedDRA, WHODRUG, or a sponsor’s customized dictionary Data reporting and export according to project requirements Data management training and consultancy Our Biostatistics Practice provides the following services: Biostatistics strategic consulting for product development and regulatory defense Sample size calculations Statistical Analysis Plan (SAP) development Clinical trial randomization SAS programming of tables, listings, and figures Statistical analysis and report preparation DSMB support and participation Integrated Summaries of Safety and Efficacy