India stands out as a leading location for early phase clinical trials due to its streamlined regulatory pathway and attractive R&D tax incentive programs.

With nearly a decade of experience across more than 400 early phase studies, our clinical team brings unparalleled expertise in the Canada and North America region, making us a trusted partner for international biotech companies seeking local knowledge and proven results.

Our early phase offerings encompass:

• Comprehensive study project management at both regional and global levels
• Development of protocols and writing of Investigator Brochures (IBs)
• Identification and selection of trial sites, including Phase 1 units for healthy volunteer studies
• Execution of studies, including coordination with ethics committees and regulatory authorities
• Design and deployment of electronic Case Report Forms (eCRFs)
• End-to-end data management services
• Biostatistical analysis, including pharmacokinetics/pharmacodynamics (PK/PD) modeling
• On-site management and monitoring
• Coordination of third-party pathology and bioanalytical lab testing and reporting
• Sponsorship and entity services across Canada and North America
• Serious Adverse Event (SAE) reporting and local medical monitoring (LMM)
• Authoring of Clinical Study Reports (CSRs)

Accelerated Product Development Through Canada and North America
Canada and North America present a compelling opportunity for international biotech firms seeking to expedite early phase clinical development through a streamlined and responsive regulatory framework. Greenline Clinical Research offers expert gap analysis and thorough evaluation of preclinical and non-clinical data to ensure each client’s submission package meets requirements and is ready for review.

Thanks to the region’s efficient and straightforward regulatory and ethics (IRB) processes, companies can often launch clinical programs in Canada and/or North America and begin patient dosing within a single 6–8 week review cycle. This flexibility may allow clients to delay regulatory submissions in other jurisdictions while accelerating development milestones locally.

The benefits for our clients include:

• Postponing expensive IND/CTA submissions when funds are limited – if you’re prepared for IND/CTA submission, you’re likely ready to start trials in Canada or North America.
• Securing Proof of Concept (POC) or First-In-Human (FIH) data sooner in the development process.
• Accessing earlier funding for the next phase, backed by POC/FIH data.
• Submitting more thorough and impactful IND/CTA applications.
• Making quicker, more informed go/no-go decisions.
• Accepting ‘GMP-like’ standards for Phase 1 studies.