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iCRAS

iCRAS

San Diego, United States· Est.
icrasinc.com
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Private Company

Total funding raised: $2.5M

Overview

iCRAS Inc. is a San Diego-based clinical research auditing services firm founded in 2018, serving medical device, biotech, and pharmaceutical companies. Its core business is providing regulatory compliance services, including GCP audits and FDA inspection preparation, to ensure the credibility and accuracy of clinical trial data. The company operates as a specialized consultancy, partnering with seasoned ex-regulatory auditors to offer global audit coverage. It is a private, likely revenue-generating services business, not a therapeutic or platform technology developer.

AI / Machine LearningDrug Delivery

Technology Platform

Human expertise-based audit and compliance program for clinical research, leveraging a network of ex-FDA and certified quality auditors.

Funding History

1
Total raised:$2.5M
Seed$2.5M

Opportunities

Increasing regulatory complexity and globalization of clinical trials drive demand for specialized compliance services.
The trend towards outsourcing non-core functions in pharma and biotech R&D provides a growing client base.
Expansion of service offerings into adjacent compliance areas (e.g., data integrity, pharmacovigilance) represents a growth path.

Risk Factors

Revenue is vulnerable to downturns in biotech funding and clinical trial activity.
The business is highly dependent on its reputation and the retention of a limited pool of expert auditors.
Competition from large CROs and other boutique consultancies pressures pricing and client acquisition.

Competitive Landscape

iCRAS competes in the niche of clinical quality assurance consulting. Direct competitors include other specialized boutique audit firms and the internal QA services of large, full-service Contract Research Organizations (CROs). Differentiation is achieved through its focus on independent auditing, its network of ex-regulatory auditors, and its targeted service portfolio.

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