India is a top choice for early-phase trials due to its streamlined regulatory process and attractive R&D cash refund program

With nearly a decade of experience and involvement in over 400 early-phase studies, our clinical team is highly skilled and established as a trusted local provider in the India & North America market, making us the preferred partner for numerous international biotech companies.

India stands out as an ideal location for early-phase clinical trials due to its streamlined regulatory process and attractive R&D tax rebate incentives.

With nearly a decade of hands-on experience managing over 400 early-phase studies, our clinical team has earned a reputation as a highly experienced local partner in the India and North America region, trusted by numerous international biotech companies.

Our comprehensive early-phase clinical trial services include:

• End-to-end project management for both regional and global studies
• Protocol development and Investigator Brochure (IB) preparation
• Site identification and selection, including Phase I units for healthy volunteer studies
• Ethics submission and regulatory coordination for trial implementation
• eCRF design and setup
• Complete data management services
• Biostatistics support, including PK/PD analysis and modeling
• Site monitoring and management
• Coordination of third-party pathology/bioanalytical testing and result reporting
• Local sponsorship and Canada/North America entity support
• Serious Adverse Event (SAE) reporting and Local Medical Monitoring (LMM)
• Clinical Study Report (CSR) development

Accelerated Drug Development in Canada and North America

The regulatory landscape in Canada and North America presents a valuable strategic advantage for global biotech firms, offering an exceptionally streamlined and responsive pathway for initiating early-phase clinical trials. Greenline Clinical Research supports sponsors by conducting thorough gap analyses and expert reviews of preclinical and non-clinical data to ensure regulatory readiness and successful submissions.

Thanks to the straightforward and efficient regulatory and ethics (IRB) review processes in these regions, companies can often launch clinical trials and begin patient dosing within just 6 to 8 weeks of submission. This accelerated timeline allows sponsors to delay more  complex regulatory filings in other regions while progressing clinical development cost-effectively and quickly.

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Benefits Realized by Our Clients:

• Delay high-cost IND/CTA filings until absolutely necessary—if your program is IND/CTA-ready, it’s likely ready to begin in Canada or North America.
• Accelerate access to Proof-of-Concept (POC) or First-in-Human (FIH) data, moving your development program forward faster.
• Secure earlier-stage funding rounds by leveraging early clinical data to demonstrate value to investors.
• Enhance the quality of global regulatory submissions by submitting more comprehensive and robust IND/CTA applications.
• Facilitate quicker go/no-go decisions, enabling more efficient use of time and capital.
• Conduct Phase 1 studies under flexible ‘GMP-like’ manufacturing conditions, acceptable within the local regulatory framework.