Configurable Clinical Trials Management Software & Services

QE understands the business processes and criticality of roles around the conduct of clinical trials. Domain expertise in these areas has evolved over a period of time, with an opportunity for QE to improve its internal procedures and quality control in processes related to these areas. For a validated clinical trial or content management system, achieving a high level of software configurability is essential in driving business processes mapped to specific technology categories. We have developed a flexible, secure enterprise architecture and backbone to achieve this in a validated manner. Our service is backed by the following:

  • Experienced core team : Headed by senior, Ph. D. level professionals with extensive experience related to NDA / PMA submissions and FDA interaction related to statistical issues
  • Enterprise-wide approach to trial analysis, meta-data/taxonomy and programming with reusable libraries & techniques
  • Configurable XML-driven data entry form creation tool
  • Patient registration, visit planning tools, providing trial updates, monitoring and trail status
  • Periodic SAS-based reporting of analysis data for various therapeutic and DMAs
  • Generating audit trials for all events
  • Protocol/site management for managing site, protocols and other trial related meta-data
  • Working with randomization plans, multi-site trial & visit plans, our CT support team augments required expertise identified by trial managers.
  • Drug codes, protocols, discovery compounds database/data management
  • Adverse event notification and recording for Pharmacovigilance studies and periodic study report notification purposes
  • Configurable CSR and FDA related tracking and reporting requirements for specific trials, time-periods, sites, countries, drugs and data analysis purposes.