Clinical Research Services
Emmes 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. Visit Biostatistics
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 Emmes’ Advantage eClinical
- 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) MORE
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