Speed
Scalability
Predictability
Drug development averages 6–7 years with less than 12% probability of success. A 2–3 month delay at Phase I can push launch by a year or more, stalling portfolio decisions and locking capital in early-stage assets. InoRx eliminates startup friction so sponsors reach first-patient-in faster.
Tufts
Overall clinical drug approval success rate
Phase I delay that can push launch timelines by 1+ year
McKinsey
Of multi-country Phase I trials experience startup delays
Big pharma pipelines carry 50–200 active clinical programs with billions invested annually. When Phase I is slow, capital locks in early-stage assets and portfolio rotation stalls. Biotech investors monitor time-to-first-patient and delays mean missed milestones and cancelled trials.
Site activation in 6–8 weeks. First patient in within 10 weeks of protocol finalization. Our pre-qualified investigator networks and volunteer registries eliminate traditional bottlenecks.
From single-cohort FIH studies to multi-arm adaptive designs — our infrastructure scales to your ambition. 20+ Phase I-ready units across 8 cities with unified oversight.
Milestone adherence you can build your IND around. Direct sponsor interaction — no multi-level global approval delays. Our standardized operating model delivers consistent execution.
From first-in-human dose escalation to complex PK/PD profiling, InoRx’s India operations cover the complete Phase I spectrum — one team, one contract, one accountable partner.
First-In-Human (FIH) Studies
PK/PD Profiling
Food Effect & Drug Interaction Studies
QT / QTc Thorough ECG Studies
SAD/MAD Dose Escalation
Biomarker & Bio-analytical Integration
Hepatic/Renal Impairment Studies
Oncology Phase 1 / FIH-Oncology
FIH & Complex Phase I
Established readiness for First-in-Human trials. Rapid mobilization in government-accredited centers on short notice.
Covaxin Phase I–III
Successfully completed Phase I–III Covaxin trials during the COVID pandemic at a single site, in collaboration with ICMR and Bharat Biotech.
Scalable Recruitment
Demonstrated scalability when recruitment load increased as sites were reduced. Strong performance in patient-based BA/BE studies.
Our lean delivery model eliminates handoff friction at every stage — one team, one contract, one accountable partner with no cold-start vendor delays.
Feasibility & Design
Protocol optimization, India-specific feasibility assessment, and site-design review with your team.
Regulatory Submissions
Parallel CDSCO CTA and IEC submissions managed by our in-house regulatory affairs team with deep CDSCO experience.
Site Activation
Contract execution, volunteer pre-screening, and site activation in 6–8 weeks using our pre-qualified Phase I unit network.
Study Execution
Dosing, PK sample collection, safety monitoring, and real-time data review managed through your sponsor portal.
Data & Reporting
Locked database, statistical analysis, and final CSR delivered on schedule — trial-ready and complete.
Talk to our Phase I team about your compound, timeline, and objectives. We’ll provide a feasibility assessment within 5 business days.