“Clindata Cloud” a disruptive Clinical Data Standardization & Risk Monitoring Platform, has been launched recently to enable Bio-Pharma and medical device companies to significantly reduce their drug development costs, risk, and duration; and comply with FDA, EMA and PMDA’s new clinical data standards (CDISC) mandate.
MON – 7th March, 2016 – 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; to get their new drugs approved for launch by FDA and other global regulatory agencies. The high cost and risk of conducting clinical trials, are a major driver in making new drugs unaffordable.
Conducting clinical trials to launch a new drug costs $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) for their IT needs. The industry’s dismal adoption of modern technologies such as big data and real time analytics, further exasperates the problem resulting in a 50 % FDA rejection rate of New Drug Applications (NDA).
To help lower the cost and risk of new drug development, FDA has mandated compliance withCDISC data standards starting from Oct, 2016. They also are recommending a Risk Based Monitoring (RBM) approach to Clinical trials to reduce site monitoring and oversight costs by 25 % and increase the safety of the subjects participating in the trials.
“We are glad to remediate this complex situation, with our disruptive Clinical Data Standardization & Risk Monitoring Platform, Clindata Cloud. Offered in an affordable Software-as-a-Service (SaaS) model. It helps companies compress their clinical trials by 8 months and costs by 5 %, hence reducing the overall cost of new drugs,” stated Sujan Thanjavuru, the founder of Clinical Data Inc.
Architected on big data and cloud computing platforms, Clindata Cloud consolidates and harmonizes clinical data from around the globe into a unified patient centric data model. It empower the clinical operations teams, with real time data insight, predictive analytics, Risk Based Monitoring and standardized data to comply with FDA data standards mandate.
“Specifically designed for clinical trials and 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,” said Paddy K. the CTO of the company.
“One of the unique features of Clindata Cloud is its ability to mine both raw and standardized clinical data, to alert of risk patterns that might lead to serious adverse reactions (SAR). The machine learning algorithms also learns over time and eliminates false alerts saving time and efforts.”
For more, log on to http://www.clindatainc.com
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