About Us
About Us
eteraflex connects accelerates clinical programs in India for biotech and medical device companies. We deliver industry-leading regulatory clearance (4-5 weeks vs. 12–16-week average), 98% first-submission approvals, and operational excellence across 280+ completed trials. From early development through commercialization, our regulatory expertise, validated site network, and technology platform reduce risk and compress timelines.
Our Foundation and Operational Heritage
18 Years of Proven Regulatory Speed, Zero-Error Compliance, and Reliable Clinical Delivery.
Founded 18 years ago, eteraflex connects has completed 280+ clinical programs spanning Phase I-IV trials, medical device evaluations, and IVD validations. Our competitive differentiation: regulatory clearance in 4-5 weeks (vs. 12–16-week industry average), 98% first-submission approval rates, and zero critical audit findings over 24 months. This track record reflects deep CDSCO relationships, established investigator networks, and systematic operational discipline. We’ve built a reputation for predictable timelines, consistent quality, and regulatory excellence—enabling clients to reach market faster while maintaining rigorous compliance standards.
Executive Leadership Team and Organizational Structure
We’re not just participants in the clinical trial ecosystem—we are innovators reshaping it.
Our leadership combines FDA and CDSCO regulatory veterans, former pharmaceutical operations executives, and clinical research specialists with 150+ years combined experience. US-based executives manage client strategy and regulatory interaction while India operations lead site management, enrollment, and quality assurance. Specialized teams cover regulatory affairs, clinical operations, data management, medical writing, quality assurance, and technology—ensuring seamless program execution. This structure bridges regulatory expertise at client meetings with operational excellence in-country, eliminating coordination delays and ensuring accountability at every program level.
Network Infrastructure and Strategic Relationships
An Integrated Clinical Ecosystem Powered by Networks, Technology, and Strategic Partnerships.
Our validated network spans 240+ clinical research sites and 180+ investigators across India’s metropolitan centers and specialty hospitals. We provide ongoing investigator development, real-time performance metrics, and tiered site classification ensuring consistent quality. Our proprietary ClintrialX and HeliX platforms deliver end-to-end enrollment tracking, compliance monitoring, and data analytics—providing operational visibility competitors lack. Supporting infrastructure includes certified central/local laboratories, specialized imaging centers, and established CDSCO relationships accelerating regulatory interactions. This integrated ecosystem enables enrollment predictability and program success.
Advisory Panel
Committed to your success, our consulting firm delivers tailored strategies and expert guidance, ensuring business excellence through precise solutions and strategic expertise for sustainable growth.
Stephane Marzabal, PhD
Program Leadership, Governance & Execution Strategy
Stephane Marzabal, PhD, brings over 25 years of leadership experience across the pharmaceutical and biotechnology industry, with deep expertise in global program leadership, clinical operations, and organizational transformation.
Roland Winger
Clinical Operations & Medical Device Development
Roland Winger is a senior clinical operations executive with nearly two decades of experience leading global clinical programs across biotechnology and medical device development.
Dr. Balram Bhargava
Strategic Advisor – Public Health & Regulatory Leadership
Balram Bhargava is a distinguished physician-scientist and former Director-General of the Indian Council of Medical Research (ICMR), India’s apex biomedical research institution.
