Clindata Cloud

Clindata Cloud is a regulatory-compliant, big data technology platform designed for biopharmaceutical and medical device companies conducting clinical trials. It consolidates study data from multiple CROs and investigative sites, automatically generating submission-ready CDISC-compliant datasets and analytics in real time throughout the life of a study. The platform addresses two core FDA requirements: mandatory CDISC data standards compliance for all pre-clinical and clinical data submissions, and the FDA-recommended Risk Based Monitoring approach to reduce site monitoring costs.

Clinical trials are typically 10–12 years long, cost over $1 billion, and carry a roughly 1% success rate. Key industry challenges include high site monitoring costs (approximately 20% of study cost), a 50% NDA rejection rate due to clinical data issues, lack of consolidated data visibility across sites, inaccurate analytics from raw EDC data, legacy technologies, and inadequate CRO oversight. Clindata Cloud is positioned to address these challenges by compressing clinical trial timelines by 8 months, cutting costs by approximately 5%, and eliminating data standards-related FDA rejections.

Clinical Data Standardization and Analytics

• Generates submission-ready eCTD Module 5 CDISC datasets — including SEND, CDASH, SDTM, and ADaM formats — in real time across the full study lifecycle.
• Provides a real-time consolidated view of study data across CROs and investigative sites.
• Eliminates data-related FDA submission rejections, which currently account for approximately 50% of NDA rejections.
• Reduces long FDA review cycles caused by non-standardized data, which can delay drug launches by up to 18 months at a burn rate of approximately $37,000 per day.
• Replaces the current practice of manual data standardization performed only at the end of Phase III studies with continuous, automated standardization throughout the study.
• Supports CRO oversight to ensure study integrity and compliance with FDA 21 CFR 312 standards.

Risk Based Monitoring

• Enables the FDA-recommended Risk Based Monitoring approach as an alternative to traditional 100% on-site source data verification.
• Analyzes both raw and CDISC-standardized datasets to comply with an FDA-approved Risk Monitoring Plan.
• Targets a reduction in investigative site monitoring costs of approximately 25%.
• Supports sponsor obligations to protect the rights, welfare, and safety of human subjects and to ensure the quality of clinical trial data submitted to the FDA.

Platform Features and Capabilities

• Conversion speed of 1 million records in approximately 12 minutes.
• Machine learning and pattern recognition algorithms for data processing and analytics.
• Graphical mapping hub for creating and modifying data mappings.
• Built-in audit trail, cross-study analytics, and regulatory and periodic reporting.
• Intuitive, role-based, system-guided navigation requiring less than 2 hours of user training.
• Supports unlimited users per study.
• Free support available 9 AM – 5 PM.

Compliance and Security

• Compliant with FDA 21 CFR Part 11, HIPAA, and GCDMP.
• Security certifications include FIMSA, PCI DSS, ISO 27001, SOC 1, SOC 2, SSAE 16, and ISAE 24.

Clindata Cloud is designed for sponsors, CROs, and clinical operations teams seeking an integrated platform that addresses both data standardization and risk monitoring requirements within a single regulatory-compliant environment.