Delivering meaningful insight to accelerate medical research.
Pentara Corporation offers clinical data analysis services to the pharmaceutical and biotechnology industries.
Pentara's work is featured in the
March 2024 issue of Nature!
By Esther Landhuis
Our Services
Pentara focuses on providing high-quality, efficient, and compliant solutions, and aims to be a trusted partner to our clients, providing innovative solutions to improve drug development outcomes.
Statistical Consulting
Pentara's Statistical Consulting Group specializes in supporting your clinical trial study design decisions with a customized and strategic approach:
- Power your study appropriately for efficacy or safety
- Measuring the right outcomes for optimal power or regulatory approval
- Use historical data or literature to improve a study’s chance of success
- Communicate complicated results effectively to a broad audience
Traditional Biostatistics
Pentara's Biostatistics Group provides traditional statistical services:
- Write statistical analysis plan with optimal statistical models and analyses
- Produce ADaM datasets and documentation for regulatory submission
- Produce tables, listings and figures for publications and statistical reports
Clinical Data Management
Pentara's CDM group will make sure your data comes in as cleanly as possible.
- EDC database set up for ease of use at the site and alignment with CDISC/CDASH standard data structures
- Ongoing review and assessment of data as it comes into the database
- Provide metrics on enrollment, data collection, and participant characteristics
- Data evaluation for rater training and fraud detection
Clinical Programming
Pentara's Clinical Programming team will ensure your study data is ready for regulatory submission.
- Creating SDTM datasets and supporting documentation for submission
- Ongoing assessment of data against SDTM standards as study progresses
- Mapping Legacy Data Into SDTM
- Custom SAS Edit Checks
- Data Visualization to support Clinical Trial Design and Execution
Medical Writing
Pentara’s medical writing team efficiently produces regulatory quality documents and publications including the following types of documents:
- Protocol / protocol synopsis
- Clinical study report
- ISS/ISE reports, clinical summary of efficacy, clinical summary of safety
- Journal articles, abstracts, posters and presentations
Regulatory Interactions
Pentara has extensive experience in regulatory interactions in the United States and Europe with expertise in neurology, psychiatry and rare diseases.
- IND submission through NDA/BLA/510K submission
- Briefing book / question formulation
- Submission of statistical methodologies for discussion, review and approval