Arcsine Analytics

Why choose Us.

Expertise. Quality. Execution. Founded by industry veterans who routinely outsourced work to CROs and were often frustrated, Arcsine Analytics is a new kind of CRO with clients as our central focus marrying decades of experience with technology and automation.

Our Mission.

Our mission is to reduce drug development and commercialization costs and timelines by expediting statistical analysis planning and execution through automation thereby enabling patients to gain access to needed therapies faster.

What we Do.

We offer statististics and statistical programming services including study protocols, statistical analysis palns, clinical study reports, data derivations (SDTM/ADaM), data analysis (TFLs), ISE/ISS, eSubmission, HTA dossiers, publications, and other work needed by our clients.

Team

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CEO
  • >20 years in pharma at xxx and xxx
  • Global roles in US, EU (Germany), India
  • Built and led biostatistics and statistical programming teams
  • Immunology, CNS, Respiratory, Cardio, Rare/Orphan
  • Extensive experience working on:
  • Phase 1-4 studies
  • Global regulatory experience
  • FDA Advisory Committee Meeting
  • PRO analysis and development
  • HTA, Medical Affairs and Publications
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VP Biostatistics
  • >xx years in pharma at xxx and xxx
  • PhD in biostatistics, MBA
  • Lead for multiple mega blockbusters
  • Immunology, Oncology, Cardiovascular
  • Extensive experience working on:
  • Phase 1-4 studies
  • Global submissions
  • Key regulatory interactions
  • PRO analysis and development
  • HTA, Medical Affairs and Publications
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VP Statistical Programming
  • >15 years in pharma at xxx and xxx
  • Led statistical programming teams
  • Won PHUSE awards for best poster and paper on data visualization
  • Respiratory, Immunology, CNS, Cardio
  • Extensive experience working on:
  • Standards development
  • Data visualization
  • Phase 1-4 studies
  • Submissions (eSub, SDTM, ADaM)
  • HTA, Medical Affairs and Publications

Services

Study Protocol

Study design to meet objectives with a particular focus on statistical design and planning.

Study Reports

Execute statistical analysis plans to produce all analyses for the study report.

ISE/ISS

ISE and ISS statistical analysis plan and execution.

SDTM/ADaM

Specifications and derivations for SDTM and ADaM including reviwer's guide and define documents.

TFLs

Produce TFLs from descriptive statistics to complex inferential statistics.

Data Visualization

Develop clear and informative data visualizations.

Statistical Analysis Plan

Comprehensive statistical analysis plans including TOC and mock shells.

Publications

Analysis and publication ready outputs.

HTA

Analyses to support Health Technology Assessment dossiers.