Clinical Trials Services (A-Z)
Supporting clinical development from pre-clinical feasibility and bioequivalence studies through Phase I–IV clinical trials and post-authorization research.
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Clinical Operations
HORUS provides integrated clinical research services supporting the full development lifecycle—from bioequivalence studies and early-phase research to Phase I–IV clinical trials. Our multidisciplinary teams combine scientific expertise, regulatory knowledge, and operational excellence to deliver efficient, compliant, and high-quality clinical trials.
Study Operations
- End-to-end clinical trial management including feasibility assessment
- Site evaluation and selection, site initiation
- Site monitoring (on-site and remote)
- Patient recruitment and retention
- Vendor management, project management
- Contract execution, ethics committee submissions
- Trial master file management, archival, and study close-out
Data Management
Comprehensive clinical data management ensuring data integrity and quality throughout the study lifecycle.
Data Management & Quality
- CRF/eCRF design and EDC configuration
- IWRS and eTMF configuration
- Data monitoring and query management
- Database lock and data transfer
- Medical coding and data review
Biostatistics
Statistical design and analysis services to ensure robust, high-quality clinical data that meets regulatory requirements.
Statistical Analysis
- Statistical Analysis Plan (SAP) development
- Sample size calculation and power analysis
- Randomization and blinding support
- CDISC SDTM and ADaM dataset preparation
- TLF (Tables, Listings, Figures) generation
- Integrated Summary of Safety/Efficacy
Regulatory & Medical Writing
Expert scientific and regulatory writing services to support submissions and publications across global markets.
Scientific & Regulatory Writing
- Clinical Study Reports (CSR)
- Investigator Brochures (IB)
- Module 2 CTD Summaries
- Study protocols and amendments
- Informed Consent Forms (ICF)
- Regulatory submissions (IND, NDA, BLA)
Clinical Pharmacology & Safety
Comprehensive pharmacology and pharmacovigilance services ensuring patient safety throughout clinical development.
Pharmacology & Drug Safety
- PK/PD analysis and modelling
- Bioanalytical method validation support
- SAE/SUSAR reporting
- Pharmacovigilance database management
- Signal detection and risk management
- DSUR and PBRER preparation
Trial Supply & Logistics
End-to-end investigational medicinal product management and clinical supply chain solutions.
Trial Supply & Logistics
- IMP importation and customs clearance
- Storage and distribution management
- Cold-chain logistics
- Dispensing and accountability
- Destruction and reconciliation
- Comparator sourcing