Clinical Trial Management
Clinical Trial Management — Phase I Through Phase IV
Zetalix manages the complete lifecycle of clinical trials across all phases. Our experienced clinical operations team ensures every study is designed for scientific validity, executed with GCP compliance, and delivered within timelines and budgets.
Capabilities:
- Protocol Development & Optimization — Scientifically robust protocols designed for regulatory acceptance and operational feasibility. Endpoint selection, sample size justification, adaptive trial design consultation.
- Site Identification & Qualification — Access to 500+ pre-qualified clinical trial sites across India.
- Investigator Selection & Training — Rigorous investigator assessment, GCP training, and protocol-specific training.
- Patient Recruitment & Retention — Data-driven recruitment, digital outreach, community engagement, patient-centric retention programs.
- Clinical Monitoring — Risk-based monitoring (RBM), on-site and remote monitoring, source document verification (SDV), real-time issue escalation.
- Clinical Supply Management — IP supply coordination, import licensing, cold chain management, labeling, accountability.
- Trial Master File (TMF) — eTMF setup, maintenance, and inspection-readiness.
Therapeutic Expertise: Oncology | Cardiology | Neurology & CNS | Metabolic & Endocrinology | Respiratory | Infectious Disease | Dermatology | Ophthalmology | Gastroenterology | Musculoskeletal | Immunology | Rare Diseases