Pharmaceutical firms want to reduce trial timelines in order to bring drugs faster, to patients in need–while managing safety, regulatory, and data quality requirements.
Sponsors face a multitude of challenges:
- Inconsistent, non-standardized, ever growing trial data in silos
- Inefficient clinical development processes
- Low visibility into treatment adherence and inefficient patient engagement
- Missing insights and analytics
- Complex regulatory requirements
These challenges prevent sponsors from leveraging the flexibility offered by adaptive trials.
Tata Consultancy Services’ (TCS’) Advanced Drug Development (ADD) is a suite of platforms for the entire clinical R&D value chain. Our platforms harness new digital technologies such as automation, AI, and IoT–to bring about disruption in clinical research and integrate key features of our intellectual property (IP) assets with commercial-off-the-shelf offerings.
This helps sponsors:
- Foster optimized study planning
- Accelerate study setup and execution
- Manage comprehensive and new data sources
- Derive meaningful insights
- Enable adherence to safety and regulatory needs
- Improve patient engagement
- Support adaptive trials
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ADD platform applies Machine First Delivery ModelTM (MFDMTM) based on Robotic Automation, Cognitive Computing, and Machine Learning, which enables resolution of industry problems to achieve business outcomes faster with reduced risks.
Key platforms of our ADD suite include:·
- Metadata Registry and Transformation (MRT): Enables metadata-driven standards lifecycle management and supports downstream clinical study data transformation
- Clinical Data Management (CDM): Enables robust EDC functionalities to support study setup, conduct and closeout phases.
- ClinOps and Insights: Provides Clinical Data Repository and monitors Clinical Operations with Analytics and Insights for addressing multiple business contexts
- Connected Clinical Trials (CCT): Improves patient engagement, enhances medication adherence and enables adaptive and virtual trial approaches.
- Integrated Patient Safety (IPS): Covers all aspects of pharmacovigilance in a predictable and cost effective manner
- Regulatory Insights: Provides analytics and insight on regulatory submission and ensures overall compliance