What You Need to Know Regarding Sharing Clinical Trial Data

With the onslaught of discussions relating to personalized medicine and patient centric approaches to drug development and our recent blog on scanning EHRs for clinical trial ...
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Top 3 Approaches using Machine Learning of EHRs to Increase Clinical Trial Recruitment

It is estimated that six million people per year are needed to fulfill US clinical trial recruitment goals, yet only two million people per year participate.  Low recruitment ...
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A Comprehensive Resource to Help Increase Your Clinical Trial Success

Results from the PwC Health Research Institute 2018 Clinician Survey indicated that physicians do not prioritize clinical trials as an option for patient care.  They found that ...
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How the FDA is Helping the Generic Drug Industry

To help facilitate efficient and successful generic drug application and approval processes, the FDA has published, a Manual of Policies and Procedures (MAPP).  This 11-page ...
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The Pros and Cons of Central IRBs

With the expanding number of human clinical trials and multi-trial sites, the need for organized, fast turn-around, and efficient Institutional Review Board (IRB) processes are ...
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Four Types of Real World Evidence to Use in Drug Development

  In an effort to make drug development more patient centric, the FDA encourages pharma and biotech companies to use real world evidence throughout all clinical trial phases.  ...
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Top Three Indicators that Your Clinical Trial is Performing Well

Tracking clinical trial performance as the study progresses allows you to measure how well it’s going and ultimately, its likelihood of success.  Yet, a clinical trial can have ...
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Bringing OTC Drugs to Market

Over-the-counter (OTC) drugs, products that can be used without a prescriber’s authorization, are developed under the OTC Monograph Process.  This three-phase process was ...
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What You Need to Know About Drug Compounding

Drug Compounding is the process of combining, mixing or altering ingredients to an existing drug to customize a drug to suit the needs of a particular patient.  For example, if ...
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