Safer & Faster Clinical Trials
To reduce the cost and risk on clinical trials and speed up the review process, FDA has mandated / guided as below :
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Mandated all Pre-Clinical / Clinical data submissions be 100 % compliant with CDISC data standards.
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Recommends Risk Based Monitoring approach to reduce site monitoring / oversight cost by 25 %.
Currently there is no affordable advanced integrated technology platform that adequately support the above requirements
Poorly Run Clinical Trials Drive Up New Drug Costs
High Site Monitoring costs (20% study cost)
50% NDA rejection rate- due to clinical data issues
Changing global regulatory requirements & data standards
Driving data blind - no view of consolidated data across sites
Inaccurate analytics based on raw data from EDC systems
Old legacy technologies and data management practices
Inadequte CRO oversight and continuous risk management
Key Challenges on Clinical Trials
Regulatory agencies require Bio-Pharma & Medical device companies to conduct extensive Clinical Trials as part of new drug development process.
Clinical Trails are long (10-12 Yrs.) expensive (Over $1billion) and high
risk with a mere 1 %success rate.
The key to reducing cost of new drugs, is to reduce the cost & risk of conducting clinical trials; by addressing
the key challenges.
Regulatory Mandate & Guidance
Clindata Cloud Solution
Clinical Data Standardization & Risk Monitoring Platform
Real time consolidated view of study data across CROs / investigative sites
Clindata Cloud is a big data, regulatory compliant technology platform that consolidates study data from multiple data sources / sites and automatically generates submission ready (eCTD Module 5) CDISC - SEND / CDASH / SDTM / ADaM datasets and analytics in real time through out the life of the study. Read more..
Key Features
FDA CFR Part 11, HIPAA & GCDMP compliant
Blazing conversion speed of 1 million records / 12 Mins
Machine learning & pattern recognition algorithms
Intuitive role based ; system guided navigation
Security Compliance : FIMSA, PCI DSS, ISO 27001, SOC1/ SOCC 2 / SSAE 16 / ISAE 24
Minimal user training (less than 2 hrs)
Graphical mapping hub to create / change data
Built-in Audit trial, cross study analytics and regulatory / periodic reporting
Unlimited Users per study
Free 9 AM - 5 PM Support
FDA mandates sponsors provide oversight of clinical trials to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.
Current Practice : On site monitoring -100 % source data verification
Key Limitations : Expensive, error prone & source of FDA citations
FDA Guidance : Sponsor's adopt Risk Based Monitoring approach
Our Solution
Risk Monitoring Platform "Clindata Cloud" enables Risk Based Monitoring by analyzing both raw and CDISC standardized datasets to comply with the FDA approved Risk Monitoring Plan.
Current Practice : Manual data standardization at end of Phase III study to partial CDISC standards.
Limitations & Challenges:
1) 50 % data related FDA submission rejections
2) Long FDA review cycle due to non-standardized data
3) Delays in drug launch sometimes up to 18 months
4) Millions in additional spend @ $ 37K / day burn rate
5) Millions in lost revenue due delay in drug launch
6) Competition launching similar drugs due to delay in launch
Our Solution
"Clindata Cloud" generates submission ready CDISC Datasets & Analytics in real time throughout the life of the study eliminating the above challenges. Read more...
