Quality Management Software For Clinical Operations In Contract Research Organizations
•Brochure: TrackWise Enterprise Quality Management System
With the continued consolidation trend in the life science industry and increased pressures on R&D investment, the Contract Research Organization (CRO) is poised to be an even more important strategic outsourcing partner. This is coupled with the growing complexities of conducting clinical studies and increasingly stringent regulations that have been implemented.
CROs are gaining momentum as a major player within the healthcare space, driven by financial and risk mitigation pressures, as well as regulatory scrutiny. As pharmaceutical and biotechnology companies continue to outsource drug discovery, CROs will continue to grow and have a need for enterprise clinical quality management technologies like TrackWise to manage all critical quality and compliance processes using a single, centralized system.
The need to measure and ensure quality is paramount throughout all aspects of the clinical trial process. TrackWise provides a flexible and configurable platform for inherently tracking and managing quality and compliance events to ensure that clinical research activities are continually measured, monitored and improved upon. As a single platform, TrackWise manages incidents, structured audit programs specifically tailored around clinical trial execution, the associated CAPA and change control, as well as trial registration and trial documentation/SOPs. The benefit of having quality and compliance procedures built into a single clinical solution is that corrective and preventive actions as well as effectiveness checks can be easily tracked to ensure continual monitoring and improvement of globally-run clinical trial processes.
Benefits of using TrackWise Quality Management Software:
- An end to end solution to track and manage all quality events and processes from pre-clinical, clinical and post-market activities
- Capture and manage OOS events from laboratory testing in GLP/GCP environments
- Bring products to market faster and more efficiently with a holistic approach to the quality and regulatory processes is critical for CROs to maintain a high level of quality service
- Track clinical projects for sponsors on regulatory approval, ethics committee review, drug availability for studies and annual reporting to countries of submission
- Comprehensive CTMS system for managing protocols, studies, study sites, patients, monitoring visits and deviations
- Conducting internal and external audits of clinical sites, suppliers, internal processes, etc. and managing the observations, CAPAs, and change control in a closed loop system
- Product Registration tracking of all licensed products in all marketed countries
- QA/QC and GxP assurance to adhere to standard operating procedures and compliance with FDA Regulations and GCP Guidelines
•Brochure: TrackWise Enterprise Quality Management System