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

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

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

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
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