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) platforms create 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 and closeout phases.
Metadata Registry and Transformation (MRT): Enables metadata standards lifecycle management and metadata driven clinical study data transformation.
- Drug Development Insights (DDI): Offers Analytics and insights solutions for addressing multiple business contexts.
- Integrated Centralized Monitoring (ICM): Facilitates comprehensive risk management, signal detection and centralized monitoring.
- Connected Clinical Trials (CCT): Improves patient engagement, enhances medication adherence and enables adaptive trial approaches.
- Integrated Patient Safety (IPS): Covers all aspects of pharmacovigilance in a predictable and cost effective manner