Clinical Research Support​

Efficient clinical development requires rigorous planning across protocol design, population strategy, and regional execution pathways. Sponsors routinely encounter challenges such as variability in disease incidence across geographies, regulatory restrictions on early-phase units, constraints in special-population recruitment (e.g., iris-pigmentation requirements for ophthalmic safety assessments), and heterogeneity in CRO quality, data integrity systems, and past regulatory inspection outcomes. These complexities are further amplified when navigating multi-region clinical strategies intended for USFDA, EMA, MHRA, Health Canada, TGA, NMPA, ANVISA and other authorities, where even minor design misalignments can compromise data acceptability or delay submissions.

Healios provides scientific and regulatory-aligned clinical development consulting, ensuring that study design, geography selection, and CRO alignment are optimized from the outset. We support sponsors in defining clinical pathways, refining early-phase and late-phase strategies, evaluating global patient-pool distributions, and identifying CROs with validated capabilities that meet program-specific and agency-specific expectations. As part of this process, Healios also assists in identifying CROs capable of securing country-specific IND/NOC approvals and meeting the prerequisite regulatory requirements for study initiation, ensuring that selected regions are operationally feasible and regulatory-compliant. This approach enables sponsors to de-risk execution, accelerate recruitment, and maximize the likelihood of global regulatory acceptance

Our support includes clinical development pathway definition, protocol refinement from a feasibility perspective, identification of regions with the highest disease incidence or fastest recruitment potential, assessment of regulatory pre-requisites for participating clinical sites, and evaluation of CRO infrastructure with respect to patient population, prior regulatory inspections, investigator experience, cold-chain/IMP handling capabilities, ophthalmic imaging standards, or device-use compliance as applicable. For ophthalmology programs, Healios evaluates geographies with suitable iris pigmentation diversity; for early-phase studies, we ensure the availability of FDA/EMA-inspected Phase I units capable of FIH, SAD/MAD, micro-dosing (Phase 0), and controlled inpatient BE studies.

Healios maintains a global network of 25 + vetted CRO partners across the USA, India, Australia, Eastern Europe, Mexico, Western Europe, UK, Africa, China and Eastern Asia, and LATAM covering capabilities in Phase 0/microdosing, first-in-human studies, healthy-volunteer bioequivalence, inpatient BE studies, proof-of-concept studies, Phase II–III multicountry programs, and some of the special studies like human-factors/usability studies, skin blanching studies, irritation and sensitization studies, phototoxicity studies, allergen challenge studies, conjunctival redness studies, insertion ease & useability studies for implants, switch studies (Rx-to-OTC conversions) among others enabling optimal matching of program needs with operational strengths.

Additional support includes assessment of regulatory acceptability of sites/CROs, evaluation of historical inspection outcomes, guidance on patient-pool projections, alignment of study design with regional ethics committee requirements, and ensuring that the selected CRO’s operational framework adheres to ICH-GCP and the expectations of global regulatory agencies. Through this strategic, evidence-driven approach, Healios maximizes clinical execution success while reducing development uncertainty.