Roadblocks impeding clinical trials standards management

Since December 2016, all drug data submissions to the US Food and Drug Administration (FDA) must conform to the standards laid down by the Clinical Data Interchange Standards Consortium (CDISC). However, most clinical data standards management solutions currently available are either suboptimal or lack end-to-end integration. This results in significant industry challenges:

• Costly protocol amendments due to rigid design as well as dissonance with downstream study design, data collection, and submission solutions
• Delays in study setup and creation of submission data due to functional standard siloes or the lack of company-wide standards integration
• Organic growth of system siloes creating various point-to-point and manual processes which are not scalable, leading to significant operational overheads

These business challenges often result in delays in study design as well as in data acquisition for meaningful analysis and reporting. The entire process is protracted, while 360-degree process workflows and collaboration tools are often absent. This extends study setup and execution timelines, significantly raising costs and resulting in unmet business needs for pharma and CROs.

Our Enterprise MDR approach
A comprehensive standards management suite for clinical data, our solution covers every stage from protocol to submission with built-in traceability. To successfully fine-tune protocol design, study setup, data collection, analysis, and creation of submission-ready deliverables, we embrace a metadata-led model.

Benefits

• Astute protocol design: Including only those procedures required to extract clinical outcomes relevant to a trial’s statistical and clinical analysis
• MDR and analytics-driven approach: Reducing amendments, data transformation, and submission to improve overall quality, efficiency, cycle time, and costs
• Reinforced compliance: Operations aligned to sponsor and regulatory requirements