Clindata

Clindata Inc. develops Clindata Cloud, a cloud-based clinical data standardization and risk-based monitoring platform designed for biopharmaceutical and medical device companies conducting clinical trials. The platform addresses two core regulatory requirements: FDA mandates for 100% CDISC-compliant data submissions and FDA guidance recommending a Risk Based Monitoring approach to reduce site oversight costs.

Clinical trials are typically 10–12 years in duration, cost over $1 billion, and carry a roughly 1% success rate. Clindata Cloud aims to reduce the cost and risk of conducting these trials by consolidating study data from multiple CROs and investigative sites, automatically generating submission-ready datasets, and providing continuous risk monitoring throughout the life of a study. The platform claims to compress clinical trial timelines by 8 months and reduce investigative site monitoring costs by approximately 25%.

Key Challenges Addressed

• High site monitoring costs, which can represent approximately 20% of total study cost
• A 50% NDA rejection rate attributed to clinical data issues
• Changing global regulatory requirements and data standards
• Lack of consolidated visibility across investigative sites
• Inaccurate analytics derived from raw EDC system data
• Reliance on legacy technologies and outdated data management practices
• Inadequate CRO oversight and continuous risk management

Clinical Data Standardization and Analytics Platform

• Automatically generates submission-ready (eCTD Module 5) CDISC datasets — including SEND, CDASH, SDTM, and ADaM formats — in real time throughout the study
• Eliminates data-related FDA submission rejections
• Reduces long FDA review cycles caused by non-standardized data
• Addresses delays in drug launch, which can extend up to 18 months, and associated costs estimated at $37,000 per day
• Replaces the current practice of manual data standardization performed only at the end of Phase III studies
• Provides real-time consolidated view of study data across CROs and investigative sites

Risk Based Monitoring Platform

• Enables Risk Based Monitoring by analyzing both raw and CDISC-standardized datasets in accordance with an FDA-approved Risk Monitoring Plan
• Supports CRO oversight to ensure study integrity and compliance with FDA 21 CFR 312 standards
• Targets a 25% reduction in investigative site monitoring costs compared to the current practice of 100% on-site source data verification
• Addresses limitations of on-site monitoring, which is characterized as expensive, error-prone, and a source of FDA citations

Platform Features and Compliance

• Compliant with FDA 21 CFR Part 11, HIPAA, and GCDMP
• Security certifications include FISMA, PCI DSS, ISO 27001, SOC 1, SOC 2, SSAE 16, and ISAE 24
• Data conversion speed of approximately 1 million records in 12 minutes
• Machine learning and pattern recognition algorithms incorporated into the platform
• Graphical mapping hub for creating and modifying data mappings
• Built-in audit trail, cross-study analytics, and regulatory and periodic reporting
• Role-based, system-guided navigation designed to minimize user training to under 2 hours
• Supports unlimited users per study
• Free support available 9 AM to 5 PM

Clindata Cloud is positioned as an integrated technology platform for biopharmaceutical and medical device sponsors seeking to meet current FDA data standardization mandates and risk monitoring guidance while reducing the overall cost and duration of clinical trials.