Accelerating Phase 1 Clinical Development

An India Model Delivering:

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.

The Challenge’s

<12% Tufts

Overall clinical drug approval success rate

2-3 Months

Phase I delay that can push launch timelines by 1+ year

70-80% McKinsey

Of multi-country Phase I trials experience startup delays

Phase I Startup Delays Are Extending Global Timelines and Slowing Pharma Portfolio Decisions

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 — delays mean missed milestones and cancelled trials.

Speed

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.

Scalability

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.

Predictability

Milestone adherence you can build your IND around. Direct sponsor interaction — no multi-level global approval delays. Our standardized operating model delivers consistent execution.

Everything Phase 1 requires. Under one roof.

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

SAD/MAD Dose Escalation

PK/PD Profiling

Biomarker & Bio-analytical Integration

Food Effect & Drug Interaction Studies

Hepatic/Renal Impairment Studies

QT / QTc Thorough ECG Studies

Oncology Phase 1 / FIH-Oncology

Proven Track Record

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.

From protocol to package. A proven path.

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.

Start your Phase I program in India today.

Talk to our Phase I team about your compound, timeline, and objectives. We’ll provide a feasibility assessment within 5 business days.