New Life Saving Drugs May Finally Become Affordable, With Clindata Cloud

NORTH WALES, Pa. - March 12, 2016 - PRLog -- The cost of new drugs and medical devices is skyrocketing making them unaffordable to many in dire need. Bio-Pharma companies are required to conduct extensive clinical trials (studies); to get their new drugs approved for launch by FDA and other global regulatory agencies. The high cost, duration and risk of conducting clinical trials, are a major driver in making new drugs unaffordable.

Conducting clinical trials to launch a new drug costs about $1.2 billion over 10 years with a success rate of less than 1 % and requires several complex regulatory compliant IT systems. Many smaller bio-pharma and medical device companies cannot afford to have IT expertise or applications in-house and instead heavily depend on their Contract Research Organizations (CROs) creating data silos across the clinical trial. This resulting lack of consolidated view of data across all the data sources adversely impacts the performance and safety of the trial. This is further exasperated by a 50 % FDA rejection rate of New Drug Applications (NDA) (https://en.wikipedia.org/wiki/New_drug_application) due to data related issues.

To help lower the cost and risk of new drug development and shorten review time, FDA (http://www.fda.gov/forindustry/datastandards/studydatasta...) has mandated compliance with CDISC (http://www.cdisc.org/) data standards beginning October 2016. FDA is also recommending a Risk Based Monitoring (RBM) (http://www.fda.gov/downloads/scienceresearch/specialtopics/criticalpathinitiative/ucm277529.pdf) approach to Clinical trials to reduce site monitoring / oversight costs by 25 % and increase the safety of the subjects in the study.

"We are glad to remediate these chronic problems, with our disruptive Clinical Data Standardization & Risk Monitoring Platform, Clindata Cloud. Offered in an affordable Software-as-a-Service (SaaS) model, it helps companies of all sizes to compress their clinical trials by 8 months and overall study cost by 5 % and eliminate clinical data related FDA rejections. It also drives regulatory compliance and subject safety, all contributing to lower cost of new drugs." stated Sujan T, the founder of Clinical Data Inc.

"Architected on big data and cloud computing platforms, Clindata Cloud sits on top of disparate data sources, such as Oracle Clinical, Medidata Rave and Medrio EDC systems (https://en.wikipedia.org/wiki/Electronic_data_capture) and consolidates / harmonizes disparate data into unified subject (patient) centric data sets that are housed in its Clinical Data Warehouse (https://en.wikipedia.org/wiki/Clinical_data_repository). It then standardizes the datasets to FDA mandated CDISC data standards at a blazing speed of 1 Million records in 10 mins in real time. This speed now makes it possible to analyze standardized data in real time unlike in the past. Clindata Cloud, empowers the clinical operations teams, with real time data insights and predictive analytics to drive safety and performance" said co-founder & CTO Paddy K.

Specifically designed for clinical trials, it eliminates the need for a large IT landscape to run clinical trials. The platform is compliant with FDA CFR-Part 11, HIPAA and GCDMP regulatory standards and is hosted on a secure private cloud. With its unprecedented scalability it can host hundreds of clinical trials in one clinical data warehouse dedicated to a client and makes cross study analytics possible in real time.

For more, log on to http://www.clindatainc.com