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A Specialist Clinical Research Organization Supporting San Francisco's Biotechnology Community

The Bay Area is home to some of the most scientifically ambitious biotechnology programmes anywhere in the world. Niche Science & Technology provides the specialist clinical research, regulatory strategy and medical writing support those programmes need to advance with precision, confidence and full regulatory compliance.
25+ years in clinical research
150+ biotech partners worldwide

Why Bay Area Sponsors Choose Niche as Their CRO Partner

The Bay Area is home to some of the most scientifically ambitious biotechnology programmes in the world. Niche Science & Technology provides the specialist clinical research, regulatory strategy and medical writing support those programmes need to advance with precision, confidence and full regulatory compliance.

From early-phase IND strategy through to clinical study reports, regulatory submissions and publication planning, we work as a seamless extension of your team, wherever you are in your development journey.

Over 25 years of experience, a multidisciplinary team and a genuine understanding of FDA expectations mean your programme moves forward on solid ground rather than uncertain footing. We bring the depth of a large CRO without the overhead, the bureaucracy, or the tendency to treat a small programme as a low priority.
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Three Disciplines, One Team, One Standard of Excellence

Our three core service areas cover everything a clinical development programme needs, from first-in-human studies through to regulatory approval and beyond.

Clinical Operations

Running a clinical trial demands rigorous operational execution from people who have done it before. We support sponsors through project management, Trial Master File and document management, study monitoring, site management and quality and vendor management systems.

Regulatory Affairs

The FDA demands clarity and an evidence base that leaves no room for ambiguity. We provide regulatory writing, strategic advice, agency submissions, QC and redaction services, and legal representation for non-US sponsors. We know what regulators need to see, and we help you present it with confidence.

Medical Communications

A strong clinical dataset deserves a strong publication strategy. We handle strategic communications, medical education, publication planning, editorial and submission services, medical illustration and grant applications. Your science, communicated with the credibility it deserves.

Supporting San Francisco's clinical development community

The Bay Area's density of biotech innovation is unlike anywhere else. South San Francisco, Mission Bay and the research networks connecting UCSF, Stanford and Berkeley create a constant pipeline of early-stage science making the transition into regulated clinical development.

That transition is where the right CRO makes an enormous difference. Whether you are filing your first IND or scaling across multiple trials, Niche brings the depth and flexibility Bay Area programmes demand.

Cell & gene therapy, from strategy to submission

Specialist experience in cell and gene therapy clinical development, one of San Francisco's fastest-growing therapeutic segments, from regulatory strategy through to clinical documentation and TMF management.
Read About The Rise of Personalised Gene Therapy

Early-phase oncology and IND-ready from day one

Supporting sponsors preparing IND submissions and early-phase oncology clinical trials, including phase 1 oncology CRO services, for biotechs working with Bay Area academic medical centres and research networks.
Read About Building a QMS For Your First-in-Human Trial

Free guides for clinical development teams in the Bay Area and beyond

Over 25 years of experience in clinical research, regulatory strategy and medical writing, distilled into practical, downloadable guides. Our Insider's Insights series covers Investigator's Brochures, clinical study reports, regulatory submissions, protocol development, publication planning and more. They are used by clinical teams at biotechs, pharmaceutical companies and academic research organisations around the world.

Explore the collection, download our guides for free and gain practical insight grounded in real-world clinical experience.

Recent Insider's Insights

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Holding a meeting

Meetings are a necessary evil but handled badly they can be a terrible waste of time. We provide insights on conducting...

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Handling Rejection

All authors will get some form of rejection from a journal at one time during in their careers. We offer some insights...

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Concept Protocols

Concept protocols are short, flexible documents that can be reviewed quickly and edited easily. We provide some insights...

Proven across programmes that matter

Our track record spans early-phase oncology trials, cell and gene therapy development, rare disease studies and large-scale regulatory submissions. The sponsors who work with us tend to stay with us, and that continuity reflects the quality of what we deliver.

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