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

 

  • Mandated all Pre-Clinical / Clinical data submissions be 100 % compliant with CDISC data standards. read more...

 

  • 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...