Clinical Research Services
Emmes offers a robust suite of services for your Phase I-IV clinical trials, registries, and other clinical research initiatives.
Clinical research management
- Infrastructure to manage clinical trials and registries
- Collaboration with research partners or oversight bodies, i.e., clinical sites, laboratories, data and safety monitoring boards, institutional review boards
- Tracking of study metrics and deliverables to ensure project objectives are met
Statistical design and analysis
- Protocol design and statistical analyses
- Central statistical monitoring
- Data and Safety Monitoring Board (DSMB) support
- Clinical Study Report (CSR) 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
- 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
Pharmacovigilance services
- Safety monitoring using Emmes’ Advantage eClinical
- Adverse Event (AE) and Serious Adverse Event (SAE) reporting on site and country levels
- Adverse event coding according to Medical Dictionary for Regulatory Activities (MedDRA)
Advantage eClinical technologies
- Suite of clinical data collection, management and analysis tools
- Electronic data capture of case report forms and other study data
- Patient randomization and blinding
- Inventory management/tracking of specimens and shipments
- Electronic patient reported outcomes (ePRO)
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 (CSR) compilation
Quality Assurance
- Auditing of study data, sites, laboratories and Contract Research Organizations (CROs) to ensure operations follow established procedures