Clinical Research Services

Emmes offers a robust suite of services for your Phase I-IV clinical trials, registries, and other clinical research initiatives.

Advantage eClinical is Emmes’ clinical trials electronic data capture platform for collecting and managing clinical trial data

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)

Emmes supports clinical trials with pharmacovigilance, eclinical technologies, regulatory affairs and quality assurance services

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
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