Clinical Data, Inc

Clinical Data Inc is a Healthcare IT Platform company based in the USA and operating internationally. It has developed a disruptive Clinical Data Standardization & Risk Monitoring Platform called Clindata Cloud. Clindata Cloud makes new drugs affordable by greatly reducing drug development costs and duration.

Designed on big data and cloud computing platforms, Clindata claims that it "compresses clinical trial duration by several months, drives significant cost savings, and improves patient safety through predictive analytics and machine learning algorithms."

Factors Driving New Drug Costs.

Clinical Trial Management: Bio-Pharma companies (Sponsors) are required to conduct extensive clinical trials to get their new drugs approved for launch by FDA and other global regulatory agencies such as the European Medicines Agency (EMA)[1] and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.[2] It costs over $1.2 billion over 10 years with a success rate of less than 1% to get a new proprietary drug to the market after extensive evidence based clinical trials.

Clinical trials are very complex and involves complex operations such as Patient and Site Recruitment, Supply Chain Management, Regulatory Affairs, Clinical Analytics etc. and should ideally be run by seasoned program and portfolio managers. However program / project management discipline and rigor is often missed on clinical trials leading to huge cost over runs and chronic delays.

Clinical Data Standards:

Large amount of subject centric clinical data is generated throughout the life of a clinical trial / study. However there is no binding mandatory requirement to submit this clinical data in a standardized format, leading to divergent data submission formats to regulatory agencies such as FDA / EMA / PMDA. This lack of uniformity of submitted data, results in longer review time of NDAs and hence more operational costs and longer duration of the trials.

Site Monitoring Costs:

It is believed that site monitoring costs account for about 20% of the clinical trial budget. Site monitoring involves among other things, 100% source data verification. This is a very exhaustive and expensive process and often prone to errors resulting in FDA citations.

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