Melior Lifesciences offers a robust suite of services for your Phase I-IV clinical trials, registries, and other
clinical research initiatives.
Statistical Design and Analysis
Protocol design and pre-study feasibility
Statistical analysis plan
Central statistical monitoring
Data and Safety Monitoring Board support
Reporting and manuscript preparation
Protocol Development and Data Management
Protocol document review for consistency, completeness and clarity
Creation of electronic Case Report Forms (eCRFs)
Deployment of electronic data capture system
Site support, data cleaning and quality control processes to ensure data integrity
Investigator, Site and Patient Services
Site identification, recruiting, selection, activation, and monitoring
Site regulatory compliance monitoring
Patient recruitment, screening, registration, blinding and management
Electronic patient reported outcomes (ePRO) data collection and support services
Site auditing to ensure study progress
Safety and Pharmacovigilance Services
Safety monitoring using Melior’ EDC Software
Adverse Event (AE) and Serious Adverse Event (SAE) reporting on site and country levels
Case processing
SAE narrative writing and submissions
Aggregate safety reporting, event trend and signal detection services
Adverse event coding according to Medical Dictionary for Regulatory Activities (MedDRA)
Regulatory Affairs Support
Country and site-level regulatory authority applications
Investigational New Drug (IND) and Investigational Device Exemption (IDE) submissions
Maintenance of Biologics License Applications (BLAs), IND applications and Trial Master Files (TMFs)
Medical writing and Clinical Study Report compilation
Advantage eClinical Technologies
Suite of clinical data collection, management and analysis tools
Electronic data capture (EDC) of case report forms and other study data
Patient randomization and blinding
Inventory management/tracking of specimens and shipments
Pharmacovigilance monitoring and management
Electronic patient reported outcomes (ePRO)
Medical Writing
Protocols for both interventional and non-interventional trials or investigations
Informed consent forms
Data management plans, statistical analysis plans, monitoring plans, site operational manuals, etc...
Clinical study reports: interventional and non-interventional trials
Product or disease registries
Manuscripts, posters, and presentations for the trial result publication
Quality Assurance
Auditing of study data, sites, laboratories, 3rd party vendors, and Contract Research Organizations (CROs) to ensure operations follow established procedures
