Health Decisions has optimized time-critical processes in clinical trials of vaccines.

Health Decisions offers compelling advantages to sponsors of vaccine studies. Although reducing time to market is important in all studies, vaccine studies are often a high-stakes race against the clock. Deadlines are often determined by seasonality or the spread of disease. Furthermore, it is difficult to compress timelines in both the early and late stages of vaccine development and production. Health Decisions has optimized many of the time-critical operational processes in clinical testing of vaccines, especially in early phases.

Experience in Vaccine Clinical Trials

Health Decisions has conducted clinical trials of prophylactic and therapeutic vaccines for a variety of indications, including influenza, cytomegalovirus, and renal cell carcinoma. The methods that Health Decisions has developed for such studies are ideal for early phase studies of many types of prophylactic vaccines, including:

  • Cytomegalovirus
  • Hepatitis A, B and C
  • Herpes Zoster
  • HIV
  • HPV
  • Influenza, including TIV, H1N1
  • Meningococcal Meningitis
  • Pneumococcus
  • Rotavirus
  • Streptococcus
  • Varicella

Advantages in Vaccine Clinical Trials

  • Real-time access to reactogenicity data
  • Ability to ensure rapid data availability and processing and ensure timely response by DSMB/SMC
  • Access to sites and subjects through our network of proven enrollers, enabling us to meet challenging enrollment deadlines
  • Proven techniques for rapid study startup, including CRF setup, database development and site selection
  • Timely site and study performance metrics to ensure that investigative sites submit data promptly, follow study procedures closely, and meet schedules
  • An efficient multi-station approach with SmartPen data capture for rapid patient processing
  • The option to use electronic source documents, greatly reducing monitoring and source-data verification costs and accelerating site closeout and database lock
  • Knowledge and experience with the BLA process

View case studies of Health Decisions vaccine clinical trials: Universal Flu Vaccine Trial Case Study and “Cure for the Common Vaccine Trial.”

Download a fact sheet summarizing Health Decisions’ capabilities in vaccine studies.
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