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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...

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