Pharmaceutical firms want to reduce trial timelines in order to bring drugs to patients in need. However, regulatory requirements for patient health and data quality are increasingly becoming stringent.
Consequently, sponsors face a multitude of challenges:
- Inconsistent trial data
- Operational inefficiencies
- Low visibility into treatment adherence
These challenges hinder mid-course corrections during trials, preventing sponsors from leveraging the flexibility offered by adaptive trials.
TCS Advanced Drug Development (ADD) platform creates a comprehensive, readily accessible data source that fosters accelerated study setup and execution, integrating key features of our intellectual property assets with commercial-off-the-shelf offerings.
This helps sponsors:
Make informed, timely decisions concerning clinical trials by provisioning varied platforms for the entire clinical R&D value chain.
Derive real-time, meaningful insights for enabling adherence to global safety and regulatory needs.
Key modules of our cloud-based platform suite include:
Integrated Data Management (IDM): enables robust EDC functionalities to support, study, setup, conduct, & closeout phases with online multilingual capabilities.
Drug development insights (DDI):, enabling multiple business use-cases, risk-based monitoring, site feasibility etc.
Integrated patient safety (IPS): covers all aspects of Pharmacovigilance (PV) including instream Workflow Management and Operational KPI’s.
Metadata Repository and Transformation (MRT): embraces a robust metadata management framework, workflow management and governance, and Bi-Directional Integration with EDC.