Your Fastest Path to Global Trial Access Starts Here
Transforming Phase I biosimilars trials with AI, regulatory integration, and ministry-embedded infrastructure — at a fraction of the cost and time of traditional CROs, fully aligned with FDA and EU standards.
Kind Shark is a specialized, AI-powered Contract Research Organization (CRO) embedded within national health systems. We help sponsors start faster, access deeper data, and enroll real-world participants more efficiently, redefining what’s possible in early-phase trials.
Innovate with us. Accelerate results. Expand access.
A New Standard for CRO Partnerships
Our Mission
Kind Shark Inc. is redefining the clinical trial model for the Global South. As the official CRO partner to Indonesia’s Ministry of Health, we integrate directly with national EMR systems and regulatory frameworks—delivering the speed, insight, and compliance global pharma demands. Our platform was purpose-built to align trial design with public health goals and execute with AI-powered precision.
Our Vision
We envision a future where clinical trials are intelligent, efficient, and truly global. By embedding AI into every layer—from cohort discovery to reporting—and partnering directly with ministries of health, we reduce friction and increase feasibility for sponsors looking to scale faster and smarter.
Services
About the Founder
Dr. Diane Gu, Founder & CEO
Dr. Diane Gu is a global health innovator and the founder of Kind Shark, a specialized CRO transforming Phase I biosimilars trials in the Global South. She has partnered with ministries of health, the Gates Foundation, and leading pharmaceutical sponsors to accelerate access to medicines, build national clinical trial capacity, and drive AI-powered trial innovation.
Her career bridges science, business, and policy. Holding a PhD and extensive leadership experience across major health and research organizations, Dr. Gu has successfully led multi-million-dollar programs, raised capital for groundbreaking solutions, and built coalitions that unite governments, investors, and innovators. She is recognized internationally as a thought leader in clinical innovation, equitable access to medicines, and the responsible use of AI in healthcare.
Dr. Gu is driven by a commitment to equity and sustainability. She believes smarter trials not only speed innovation and save pharmaceutical sponsors billions, but also ensure patients everywhere — especially in underserved regions — gain faster access to life-saving therapies. For her, Kind Shark is proof that doing well by doing good is more than a motto — it’s a business model.
