Accelerating Breakthrough Therapies with AI-Powered Clinical Intelligence

We partner with biopharma innovators, combining deep therapeutic expertise with advanced AI to deliver high-quality data, reduce risk, and bring life-changing treatments to patients, faster.

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An Integrated Suite of Services

We provide an end-to-end partnership, designed to support your clinical development journey from initial strategy to regulatory approval and beyond.

Full-Service Clinical Development

We provide end-to-end support for your clinical trials. Our expertise spans the entire lifecycle, from early-phase development, FIH, and dose escalation studies to pivotal Phase 3 trials and post-marketing commitments. We specialize in complex study designs for oncology, hematology, and rare diseases, ensuring diligent patient safety monitoring, robust data collection, and operational excellence across global sites.

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Clinical Development
Regulatory

Strategic Regulatory Support

Navigate the complex regulatory landscape with a proven partner. We specialize in strategies for expedited approval pathways, including Fast Track, Breakthrough Therapy, and Accelerated Approval. Our team has direct experience with over 27 INDs, 9 NDAs, and 3 BLAs, providing invaluable insights to de-risk your submission and optimize your path to market for high unmet medical need therapies.

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Safety & Pharmacovigilance

Comprehensive safety monitoring and PV operations to protect patients and support regulatory reporting. We provide signal detection, aggregate reporting, and inspection readiness to ensure your program meets global safety standards. Our physician-led safety oversight ensures expert benefit-risk assessment and regulatory preparedness.

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Safety & Pharmacovigilance
AI & Data Analytics

AI-Powered Data & Analytics

Our AI platform transforms clinical trial data into a strategic asset. We offer real-time data integrity checks, predictive analytics for site performance and patient enrollment, and advanced safety signal detection. By handling huge volumes of multi-modal data, we accelerate analysis and provide the high-quality evidence needed for faster, more confident regulatory submissions.

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Deep Therapeutic Expertise

Our profound understanding of complex diseases is the foundation of our success. We bring specialized clinical and operational experience to the most challenging areas of drug development.

Oncology & Hematology

Expertise in CAR-T, ADCs, and oncolytic virus therapies. Deep experience in relapsed/refractory metastatic cancers.

130+ Oncology Trials Led

Rare Diseases

Agile and patient-centric solutions for studies with unique challenges and high unmet needs.

Orphan Drug Designation Support

Cell & Gene Therapy

Navigating the complexities of advanced therapies from clinical strategy to regulatory filing and commercialization.

Direct CAR-T BLA Approval Experience

Value Delivered, Quantified

Our AI-powered, expert-led model delivers tangible results, improving the speed, quality, and efficiency of your clinical trials.

Our Leadership

Founded by industry veterans who have successfully bridged the gap between cutting-edge clinical science and transformative technology.

Dr. Ashok Srivastava

Dr. Ashok Srivastava

MD, PhD, MBA

President & Chief Medical Officer

A board-certified oncologist with over 17 years of global leadership in oncology R&D, instrumental in filing dozens of INDs/NDAs/BLAs and a leading expert in CAR-T cell therapies.

Elias Tharakan

Elias Tharakan

Chief Executive & Technology Officer

A visionary lifesciences technology executive who architected a leading unified eClinical SaaS platform that powered over 1,000 trials and contributed to dozens of drug approvals.

Ready to Redefine Clinical Development?

Let's discuss how AyurDatta can become the catalyst for your next breakthrough. Contact us to schedule a consultation with our experts.

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