Services

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Services

Clinical Research Services

We work in a range of settings and manage randomized clinical trials, case-control studies, registries, observational studies, animal experiments, gene transfer, field surveys, nutritional surveys, quality of life surveys, and medical data monitoring studies.

Collaboration between researchers and practitioners is critical, and our team understands how to blend practicality and rigor in every study. We’re proud of our long, successful track record in all phases of managing a research project, from selecting the right sites to recruiting patients … from study design to protocol development … from biostatistical analysis to reporting.

Clinical Research Management

  • Infrastructure to manage clinical trials and registries
  • Collaboration with all other research partners or oversight bodies, such as clinical sites, reading centers, labs and Data and Safety Monitoring Boards (DSMBs)
  • 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

Clinical Site Management

  • Site qualification, selection and contracting
  • Site training and site improvement plans
  • Site enrollment planning
  • Site monitoring

Pharmacovigilance Services

  • Safety monitoring using Emmes’ Advantage eClinical
  • Adverse Event (AE) and Serious Adverse Event (SAE) reporting
  • Adverse event coding according to Medical Dictionary for Regulatory Activities (MedDRA) and drug coding according to World Health Organization (WHO) Drug
  • Country and site-level reporting of SAEs

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 sites, laboratories and Contract Research Organizations (CROs) to ensure operations follow established procedures
Disease Areas

Our experience encompasses a diverse set of disease areas

Allergies

Autoimmune Disorders

Cardiovascular

Communication Disorders

Oral Health

Infectious Diseases

Maternal/Child Health

Nephrology

Neurology

Oncology

Ophthalmology

Respiratory

Substance Abuse

Transplantation

Case Study

Vaccines to combat epidemics

Emmes’ early work in clinical trials for avian and swine flu vaccines was followed by a truly Herculean effort: two trials associated with the potential of large avian influenza threat. This required innovative approaches, absolute accuracy and dramatic speed, because our researchers needed to simulate how quickly the government could respond in a public health emergency while still performing valuable research. We launched the studies in just five business days. Our team made important contributions to vaccine science and to the planning and preparation for potential epidemics. Our newest challenge: studies that consider genetics in understanding how immune cells respond to vaccination.