Clinical Research Support Services
Strategic Clinical Development & CRO Selection
Efficient clinical development depends on rigorous planning across protocol design, population strategy, and regional execution pathways. Sponsors frequently encounter challenges such as variability in disease incidence across geographies, regulatory restrictions on early-phase units, constraints in special-population recruitment (for example, iris pigmentation requirements for ophthalmic safety assessments), and heterogeneity in contract research organisation (CRO) quality, data integrity systems, and prior regulatory inspection outcomes. These complexities intensify when navigating multi-region clinical strategies intended for the USFDA, EMA, MHRA, Health Canada, TGA, NMPA, ANVISA, and other authorities, where even minor design misalignments may compromise data acceptability or delay submissions.
Healios addresses these challenges by delivering an integrated approach that combines regulatory expertise, scientific rigor, and strategic CRO selection, enabling sponsors to proactively mitigate risks and optimize pathway design for successful global submissions.
Healios Clinical Development Engagement Approach
Needs Assessment & Discovery
Program Review & Gap Analysis
Clinical & Regulatory Strategy
CRO Identification & Due Diligence
Detailed Operational Planning
Healios offers scientific and regulatory-aligned clinical development consulting to ensure that study design, geography selection, and CRO alignment are optimised from the outset. A typical engagement with Healios encompasses several key phases: initial needs assessment and discovery, comprehensive program review and gap analysis, development of tailored clinical and regulatory strategies, CRO identification and due diligence, and detailed operational planning. Once the engagement scope is defined, Healios guides sponsors through pathway definition, study design refinements, and geographic region selection, while ensuring CRO alignment with program- and agency-specific expectations.
Additionally, Healios helps identify CROs capable of securing country-specific IND/NOC approvals and meeting prerequisite regulatory requirements for study initiation, ensuring selected regions are operationally feasible and regulatory-compliant.
This phased approach enables sponsors to reduce execution risk, accelerate recruitment, and maximize the likelihood of global regulHealios provides support that 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 prerequisites for participating clinical sites, and evaluation of CRO infrastructure regarding patient population, prior regulatory inspections, investigator experience, cold-chain/investigational medicinal product (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, Healios ensures access to FDA- or EMA-inspected Phase I units capable of first-in-human (FIH), single-ascending dose/multiple-ascending dose (SAD/MAD), micro-dosing (Phase 0), and controlled inpatient bioequivalence (BE) studies.
For example, Healios recently supported a mid-sized biotechnology sponsor developing an ophthalmic therapy that required recruiting patients with diverse iris pigmentation.
The sponsor had previously experienced slow enrollment due to narrow geographic targeting and insufficient regulatory readiness. Healios conducted a rapid feasibility analysis to identify optimal countries with high disease incidence and broad iris diversity.
Subsequently, they vetted local CROs with a proven track record in regulatory compliance and patient recruitment. By aligning protocol requirements with regional standards and efficiently securing IND approvals, Healios enabled the sponsor to achieve full enrollment within the targeted timeline and to satisfy regulatory requirements for both USFDA and EMA submissions.
Global CRO Network & Specialized Study Capabilities
Healios maintains a global network of more than 25 vetted CRO partners across the USA, India, Australia, Eastern Europe, Mexico, Western Europe, the UK, Africa, China, Eastern Asia, and LATAM.
Early-Phase Studies
Phase 0/microdosing, first-in-human studies, healthy-volunteer bioequivalence, and inpatient bioequivalence studies.
Clinical Development Programs
Proof-of-concept studies and Phase II–III multicountry programs.
Specialized Clinical Studies
Human-factors and usability studies, skin blanching, irritation and sensitisation, phototoxicity, allergen challenge, conjunctival redness, insertion ease and usability for implants, and switch studies (Rx-to-OTC conversions), among others.
Regulatory & Quality Assessment
ICH-GCP standards, regulatory inspection track record, data integrity systems, patient recruitment performance, therapeutic area expertise, and demonstrated compliance with global and local regulatory requirements.
These partners offer capabilities in Phase 0/microdosing, first-in-human studies, healthy-volunteer bioequivalence, inpatient bioequivalence studies, proof-of-concept studies, Phase II–III multicountry programs, and specialised studies such as human-factors and usability studies, skin blanching, irritation and sensitisation, phototoxicity, allergen challenge, conjunctival redness, insertion ease and usability for implants, and switch studies (Rx-to-OTC conversions), among others.
This network enables optimal matching of program needs with operational strengths. CRO partners are rigorously vetted for adherence to ICH-GCP standards, regulatory inspection track record, data integrity systems, patient recruitment performance, therapeutic area expertise, and demonstrated compliance with global and local regulatory requirements, assuring sponsors of quality and regulatory compliance throughout every engagement.
Additional support includes assessing the regulatory acceptability of sites and CROs, evaluating historical inspection outcomes, providing guidance on patient-pool projections, aligning 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.
Clinical Development Outcomes
Through this strategic, evidence-driven approach, Healios maximises clinical execution success while reducing development uncertainty. On average, sponsors partnering with Healios have achieved up to a 25% reduction in timeline delays, a 30% improvement in recruitment rates, and significantly higher success rates in meeting first-cycle global regulatory submission requirements, resulting in faster market access and improved predictability across clinical development programs.
