making new drugs affordable ....
Risk Based Monitoring | Clinical Data Standardization | Real Time Analytics
Clinical Trials drive up drug new drug costs
High Site Monitoring costs (20% study cost)
50% FDA submission 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
No CRO oversight and continuous risk management
Reguarlatory agencies require Bio-Pharma & Medical device companies to conduct extensive Clinical Trials as part of new drug development process.
Clinical Trails are long (10 Yrs) expensive ($1billion) and high risk with a success rate of mere 1 %.
The key to reducing cost of new drugs, is to reduce the cost & risk on clinical trials; by addressing the critical challenges. Read more ...
Key Challenges on Clinical Trials
Regulatory Mandate & Guidance
To reduce the cost of clinical trials / rejection rate 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. read more...
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Recommends Risk Based Monitoring approach to reduce site monitoring / oversight cost by 25 %. Read more...
Currently there is no affordable advanced integrated technology platform that adequately support the above requirements
Clindata Cloud Solution
Clinical Data Standardization & Risk Monitoring Platform
Real time consolidated view of study data across CROs / investigative sites
Clindata Cloud, our patent pending platform is designed and built, specifically for clinical trials; eliminating the need for a large and expensive IT landscape. Smaller sponsors and CROs can now manage their study risk and regulatory compliance affordably in a SaaS model.
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
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" to enable Risk Based Monitoring based on a combination of raw and CDISC standardized datasets as per FDA recommendation
Current Practice : Manual data standardization at end of the study to partial CDISC standards.
Current Practice Limitations:
1) 50 % data related FDA submission rejections
2) Long FDA review cycle due to non standardized data
3) Delays in drug launch sometimes upto a 12 - 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
Technology Platfrom "Clindata Cloud" that generates submission ready CDISC Datasets & Analytics in real time throught the life of the study. read more...
