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.  ...
Read More

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 ...
Read More

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 ...
Read More

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 ...
Read More

Are Virtual Clinical Trials the Key to Patient-Centric Drug Development?

Patient recruitment and sustained enrollment is absolutely essential to the success of drug development.  However, it’s been shown that nearly 80% of clinical trials fail to ...
Read More

Highlights from the PricewaterhouseCoopers 2017 FDA report

The FDA has hit a 20 year low in the issuance of new federal regulations according to the findings in a new report published by PricewaterhouseCoopers (PwC).  In 2017, we saw ...
Read More

Top 3 Attributes That Make an Excellent Clinical Research Coordinator

In the absence of a good clinical research coordinator (CRC), your trial has an increase chance of failing.  The crucial role of the CRC in facilitating the daily clinical ...
Read More

5 Tips for Running an Effective International Clinical Trial

Pharma and biotech companies are always looking for ways to increase market size to help get their drug to those who may benefit.  And, let’s be realistic here, they’d also ...
Read More

3 Key Steps for Optimizing Your Clinical Site Budgeting Process

This blog reviews key concepts in our new eBook, “How to Budget Sites for Clinical Trials”.  Click here to download your free copy. In part II of this blog series highlighting ...
Read More