Our Service
Clinical Trials Services
At Globaxa, we specialise in early-phase clinical development (Phase I and Phase II) — the critical first steps in translating your novel therapies into clinical success.
Descriptions
From initial study design to human dosing, our services span the full early-phase spectrum:
Study design & planning: clear protocol development, feasibility assessment, risk mitigation.
Clinical trial conduct: site initiation, patient recruitment, oversight of dosing, safety and tolerability.
Patient & site management: efficient site selection, training, patient retention strategies for seamless execution.
Clinical pharmacology services: detailed PK/PD profiling and bioanalysis to characterise your molecule’s human behaviour.
Data management & analysis: robust data capture, cleaning, statistical review to drive timely decision-making.
Specialized capabilities: adaptive trial design, master protocols (a single protocol addressing multiple objectives), dose-escalation frameworks.
Regulatory & compliance support: navigating local and global ethics, GCP standards, and regulatory submissions.
Integrated services: we act as your single point partner, uniting strategy, execution and data under one roof.
Late-Phase Clinical Development
When your programme advances to Phase III or moves into post-marketing Phase IV, Globaxa stands ready to deliver late-phase clinical development services that ensure your product is proven at scale, prepared for market entry, and post-launch success.
Our late-phase service offerings include:
Clinical study design & planning: large-scale trial architecture, endpoint strategy, global site coverage.
Study management: full project oversight, milestone tracking, resource alignment and vendor/sponsor coordination.
Monitoring & data collection: onsite and remote monitoring, electronic data capture, safety event tracking and query resolution.
Data management & biostatistics: advanced biostatistical modelling, database design, interim and final analyses.
Pharmacovigilance & safety monitoring: proactive risk management, signal detection, global safety compliance.
Regulatory affairs: dossier readiness, regulatory liaison, submission support and compliance across markets.
Commercialisation & market access: linking trial evidence to market strategy, reimbursement considerations, real-world data support.
Technology integration: advanced platforms for remote monitoring, e-consent, patient engagement and real-time insights.
When you partner with Globaxa for your late-phase programme you benefit from:
Scalability: capacity to manage large, multicentre, multiregional trials seamlessly.
Cost & time efficiency: optimised processes reduce overheads and accelerate path-to-market.
Compliance assurance: rigorous adherence to GCP and international regulatory standards ensures data integrity and credibility.
End-to-end alignment: from trial execution to market readiness, our services transform evidence into commercial success.
Why Choose Us
