San Francisco Bay Area Biometrics Consulting
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San Francisco Bay Area Biometrics Consulting
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Industry Solutions

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Curved
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Biopharma Industry Solutions

The journey of a novel pharmacological or biological therapeutic to market is one of many obstacles.  Only 9% of new molecules and biologics make it to Phase III of clinical trials.  From drug discovery to FDA approval, developing a new medicine on average takes 10 years, with a cost of $2.6 billion, which includes the cost of many potential medicines that do not make it through FDA approvals. In spite of these tremendous challenges, biopharmaceuticals companies have developed many Innovative Medicines that have drastically improved patient’s health and saved lives. We, at Clindata Insight, are committed to applying the latest statistical and computational science to support biopharma to advance the pipeline and to serve patients world wide. We are experienced with New Drug Application (NDA) of small molecule trials as well as oncology trials to FDA Center for Drug Evaluation and Research (CDER) and Biologics Licensing Application (BLA)  for biologics trials to FDA Center for Biologics Evaluation and Research (CBER).  We are equipped and prepared to bring in statistical and programming expertise and help you manage data-related challenges throughout this substantial undertaking, whether it is trial design issue, obtaining the necessary talent for various projects, submission data strategy,  or FDA clinical data structure compliance, we can catalyze specific stages of your pathway to success.

 

 

 

 

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Gregory Motta
17 May 2016
Theme: Metadata Repositories – Promises and Realities Description: The Pharmaceutical industry recog...
Richelle Serrano
23 May 2016
Over the last five years, the CSS has grown from its infant years, passed through adolescence and ma...
Admin
01 July 2016
Our team will be at WUSS 2016 Educational Forum and Conference.  Please come by and say hello. ...
Admin
19 January 2017
Clindata is proud to sponsor the next SF Bay Area CDISC meeting being held on February 9, 2017 at 12...

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Clindata Insight Inc, provides equal employment opportunities (EEO) to all applicants for employment without regard to race, color, religion, sex, national orgin, age, disability or genetics.  In addition to federal law requirements Clindata Insight complies with applicable state and local laws governing non discrimination in employment.

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