Safer & Faster Clinical Trials 

25 %

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 

 

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 

Poorly Run Clinical Trials Drive Up New Drug Costs

Clindata Cloud Solution

Clinical Data Standardization & Risk Monitoring Platform

8

Months

100 

%

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. 

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

 

Real time consolidated view of study data across CROs / investigative sites

To reduce the cost and risk on clinical trials 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. 

  • 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

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

 

"Clindata Cloud"  generates submission ready CDISC Datasets & Analytics in real time throughout the life of the study eliminating the above challenges. Read more...

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. 

Regulatory Mandate & Guidance

Key Challenges on Clinical Trials 

© 2019 Clinical Data Inc