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Pentara Corporation offers clinical data analysis services to the pharmaceutical and biotechnology industries.

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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

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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

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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

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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

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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

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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

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