Streamline your SAP writing

with a tool built by biostatisticains and data scientists.

Book a Demo

Generate SAPs informed by Guidance Documents

BlackCat Bio identifies relevant guidance for your indication and therapeutic area, ensuring your SAP incorporates the latest methodological recommendations from regulatory authorities. This reduces revision cycles and strengthens your regulatory submission strategy from the outset.

Optimize approval odds based on FDA statistical reviews

BlackCat Bio analyzes FDA Statistical Reviews and CRLs from approved and rejected drugs in your indication to identify the analysis approaches, endpoints, and methodologies that satisfied reviewers. This intelligence allows you to benchmark your SAP against real-world regulatory decisions, addressing potential FDA concerns before submission and designing studies that align with demonstrated approval pathways.

And get it all reviewed by an expert biostatistician at a fraction of the cost.

For Biostatisticians

Use BlackCat Bio to assist in your SAP generation and evaluation workflows to increase your contract capacity.

For Clinical Operations

Don't have a biostatistician you know to work with you on your study? Work with Barbara and BlackCat Bio to get your needs met at a fraction of the normal cost.

BlackCat Bio Team

Barbara Elashoff

I am a former FDA statistical reviewer who has reviewed hundreds of protocols and SAPs. I've also worked in pharma and biotech for the past 20 years. I have experience across a wide variety of therapeutic areas including pulmonary, autoimmune, metabolic, cardiovascular, dermatology and analgesia. I have a proven track record of successful regulatory submissions including NDAs, PMAs, 510(k)s, and BLAs.

View my CV

Publications

Shoham Das

AI-focused software engineer and data engineering leader with 7+ years of experience delivering scalable systems across biotech, healthcare, and venture. Skilled in building full-stack applications, data infrastructure, and AI-powered tools that support scientists, clinicians, and investors—spanning high-throughput experimentation, therapeutic discovery, and portfolio strategy.

Github

I highly recommend Barbara as a biostatistician, strategist and clinical development expert. As a biostatistician, Barbara is in her element, performing all aspects of stats-related development, from early protocol design and authoring, to high quality statistical analysis plans, to providing statistical outputs and clinical study reporting.

Abby Kennedy, VP Clinical Operations

See how BlackCat Bio can support your biostatistical needs.

Book a Demo