About Us

Our Approach

InoRx is a next-generation Contract Research Organization (CRO) built to accelerate biotech clinical development through innovation, patient access, and operational excellence. Headquartered in the United States with operations in India, InoRx delivers faster, more cost-effective, and highly reliable clinical studies for sponsors worldwide.

Our foundation

What Sets InoRx Apart

InoRx combines integrated infrastructure, advanced technology, and rigorous quality standards to help sponsors design smarter studies and execute with precision.

Our capabilities

Therapeutic Expertise

InoRx brings focused clinical and operational experience across key therapeutic areas where patient access, site performance, and execution speed matter most.

Strategy & Planning

We help plan smarter clinical trials by focusing on patients, feasibility, and enrollment strategies that reduce risk and keep studies on track.

Our Vision

Improving lives through faster access to innovative therapies

We believe patients everywhere deserve timely access to safe and effective treatments. Our vision is to help advance global health by enabling high-quality clinical research that removes barriers, expands patient access, and supports medical innovation worldwide.

Our Mission

Helping innovators bring treatments to patients sooner

Our mission is to accelerate clinical research through patient-centric trial design, efficient execution, and strong clinical partnerships. By simplifying complexity and maintaining the highest quality standards, we help sponsors move their studies forward with confidence and speed.

Our Leadership Team

Meet the Experts Driving InoRx Forward

Dr. Avi Kulkarni

Chief Executive Officer

Divya Yerraguntla

Chief Client Officer

Gregory T. Simpson

Chief Marketing Officer

Dr. Melvin 1 - 2.26

Dr. Melvin George

Chief Medical Officer

Vinayaka Shahavi, PhD

Chief Operations Officer

Bharat Kshirsagar, PhD

Head of Regulatory Affairs

Dhanraj Vyankatrao Jadhav

Head of Quality

Dr. Nitin M Nagarkar - Distinguished Advisor

Special Advisor

Dr. Nagarkar brings over three decades of expertise in medical education, healthcare leadership, and clinical research. Former Director of AIIMS Raipur and current Pro Vice-Chancellor (MHS) I/C at SRMIST, he provides strategic guidance and advisory support to our organization.

He has authored 150+ scholarly articles, written two books, contributed to six book chapters, and holds three patents. During his tenure at AIIMS Raipur, he led major advancements in ENT and oncosurgery and participated in over 100 national and international conferences.

Recognized nationally for his contributions, he has received multiple awards including the Distinguished Service Award from Delhi Medical Association and the Times of India Icons of Health Award. His guidance drives innovation and excellence in medical education and healthcare.

Dr. Avi Kulkarni

Chief Executive Officer

As InoRx’s Chief Executive Officer, Dr. Avi Kulkarni leads the company’s mission to accelerate global clinical development through innovation, patient access, and operational excellence. He brings more than three decades of leadership experience across pharma, diagnostics, consulting, and clinical research.

Before leading InoRx, Avi served as Chief Executive Officer of ThoughtSphere, an AI-powered clinical data and analytics company. Earlier in his career, he held senior executive roles at Syneos Health, Cognizant, IQVIA, KPMG, and Booz & Company, guiding large-scale R&D and clinical transformation programs. He has also founded and managed molecular diagnostics and clinical research organizations focused on precision medicine and cell and gene therapy.

Avi holds a Ph.D. and M.S. in Pharmaceutics from Temple University, an MBA from Stanford University, and a B.S. in Pharmacy from the University of Bombay. He serves on the boards of ThoughtSphere and SRM Technologies.

Divya Yerraguntla

Chief Client Officer

Divya Yerraguntla is Chief Client Officer at InoRx, where she leads client partnerships, business development, and strategic growth across the biopharma and biotech sectors. She brings more than 25 years of experience in pharmaceutical commercialization and CRO leadership, with a strong record of helping sponsors advance therapies from development through launch.

Before joining InoRx, Divya served as Senior Vice President of Strategic Business Development at Syneos Health and held senior commercial roles at Sun Pharma, Novo Nordisk, and Johnson and Johnson. She has led more than 30 global product launches across multiple therapeutic areas and co-founded AI-Enabled Health, a healthcare innovation think tank.

Divya holds an MBA from Rutgers Business School and an M.S. in Mathematics from the Indian Institute of Technology Kanpur.

Gregory T. Simpson

Chief Marketing Officer

As InoRx’s Chief Marketing Officer, Gregory T. Simpson leads the company’s brand strategy, demand generation, and go-to-market execution to position InoRx as the preferred partner for biotech sponsors worldwide. He brings deep global marketing experience and a proven track record of scaling companies serving the life sciences industry from early-stage growth to billion-dollar outcomes.

Before joining InoRx, Greg held senior marketing leadership roles at Medidata Solutions, and Saama Technologies where he drove transformative growth, market expansion and brand visibility. He also served as Chairman of a $4B financial institution.

Greg holds an MBA in Marketing and an M.S. in International Business from Seton Hall University, along with governance certifications from Columbia Business School and the National Association of Corporate Directors.

Dr. Melvin George

Chief Medical Officer

Dr. Melvin George is InoRx’s Chief Medical Officer, where he leads medical and scientific oversight across all clinical programs. He brings more than 15 years of experience in clinical pharmacology, academic research, and hospital-based clinical trials, guiding InoRx’s commitment to scientific integrity, patient safety, and operational excellence.

Dr. George is also a Professor and Head of the Centre for Clinical Pharmacology and Centre for Clinical Trials & Research at SRM Medical College Hospital and Research Centre, overseeing multi-disciplinary studies in areas such as coronary artery disease, acute coronary syndrome, heart failure, COPD and dengue. He has acted as Principal Investigator or Co-Investigator on more than 65 clinical studies, including multi-center international randomized controlled trials. He is currently Principal investigator for the Indian Council for Medical Research’s Phase 1 Clinical Trials Centre for Advanced Research at SRM Hospital.

Dr. George has published over 1600 peer-reviewed papers and 10 textbook chapters, holds an h-index of 24 with 1,600 citations, and is a frequent invited speaker on research methodology, bioethics, and biostatistics.

He earned his DM and MD in Clinical Pharmacology from JIPMER, Pondicherry, and his MBBS from the same institution.

Vinayaka Shahavi, PhD

Chief Operations Officer

Dr. Vinayaka Shahavi is Head of Clinical Operations at InoRx, where he leads global clinical trial execution and delivery excellence across therapeutic areas. He brings more than 20 years of experience in clinical development and operations, supporting biopharma sponsors through complex, regulated trial environments.

Before joining InoRx, Vinayaka held senior clinical operations leadership roles at CROs and sponsors such as Clininvent Research, Sanofi Aventis and Alkem Laboratories, where he managed multi-country studies from feasibility through closeout. His experience spans multiple therapeutic areas and complex indications, with a strong focus on patient safety, data integrity, and compliance with global regulatory and quality standards.

Vinayaka holds a PhD, an MBA in Project Management, is ARCP certified, and is currently pursuing an LLB. He is known for his disciplined, execution-focused leadership style, combining deep scientific understanding with operational rigor to help sponsors deliver reliable trials and advance therapies efficiently.

Bharat Kshirsagar, PhD

Head of Regulatory Affairs

Dr. Bharat Kshirsagar is the Head of Regulatory Affairs at InoRx and a seasoned clinical regulatory professional with over 17 years of experience across regulatory affairs, clinical development, and global regulatory submissions. His expertise spans regulatory strategy, clinical and CMC documentation, and lifecycle management for small molecules, biologics, biosimilars, peptides and drug–device combination products across the United States, Europe, India and other global markets.

Prior to joining InoRx, Bharat held senior regulatory leadership roles at Parexel, Biocon Pharma Limited, and USV Private Limited, where he contributed to global regulatory submission strategies and preparation of key regulatory documents for IND, NDA, BLA, MAA, ANDA, and IMPD submissions, including CTD modules and regulatory briefing packages. He has also supported interactions with regulatory authorities such as the USFDA, EMA, and CDSCO. Earlier in his career, he gained experience in clinical operations and clinical trial management, providing him with a strong understanding of the drug development lifecycle.

He holds a PhD in Pharmacology, along with a Master’s degree in Pharmacy (Pharmacology) and a Bachelor’s degree in Law (LLB). Bharat is recognized for his ability to integrate clinical development strategies with regulatory pathways, enabling sponsors to successfully navigate complex global regulatory environments.

Dhanraj Vyankatrao Jadhav, RQAP-GCP

Head of Quality

Dhanraj Vyankatrao Jadhav is Head of Quality at InoRx, where he leads the development and oversight of the company’s Quality Management System, ensuring compliance with global regulatory standards and client expectations. He brings nearly two decades of experience in clinical quality assurance across generic, innovator, and biosimilar drug development programs.

Before joining InoRx, Dhanraj held senior clinical quality and regulatory compliance roles at Lupin, Fortrea, Syneos Health, and Reliance Life Sciences, where he led global GxP audit programs, hosted regulatory inspections, and drove risk-based quality strategies. His expertise spans investigator site audits, vendor qualification, mock inspections, CAPA management, and global inspection readiness across multiple regions including Asia-Pacific and Europe.

Dhanraj is a Registered Quality Assurance Professional in Good Clinical Practice and holds degrees in Pharmacy, Law, and Business Administration. He is recognized for his proactive leadership approach and commitment to building robust quality systems that ensure safe, compliant, and efficient clinical development.