![[header_logo.jpg]](http://www.quantument.com/en/uploads/images/header_logo.jpg "Quantum Enterprises, Inc."){kind=logo}
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.