Blogs

December 1, 2016

Quality Risk Management For Aseptic Processing!

According to the food and drug agency (FDA), sterile drug products are manufactured by two methods. They are terminal sterilization and aseptic processing. […]
November 29, 2016

7 Important Skills Needed To Become A Data Scientist!

A data scientist is broadly considered to be a person who gathers information/data on a large scale and uses his/her statistical, analytical, and […]
November 28, 2016

Best Practices For Selecting A Clinical Trial!

The best practices for clinical trial operations are difficult to define/describe due to clinical trials being diverse in nature. Yet there are certain […]
November 25, 2016

Regulatory Reporting Timelines For ICSRs In Pharmacovigilance?

When a healthy volunteer/patient suffers a negative health reaction to a drug being tested in clinical trials, an adverse event is reported and […]
November 23, 2016

What is Adverse Drug Reaction?

When a patient/volunteer being administered a drug under clinical trials or outside trials in the case of a treatment regimen, undergoes an adverse […]
November 21, 2016

Why Are Clinical Trials For New Drugs Expensive?

Clinical trials refer to and involve testing new drugs for diseases and other negative health conditions that affect human beings and discovering information […]
November 18, 2016

Ten Things to Know Before Joining Clinical Trials!

Clinical trials are how researchers and chemists working with drug companies check out the effectiveness of new drugs before they are made available […]
November 14, 2016

What Are the FDA’s New Compounded Drug Guidelines?

The FDA aims to protect the health of U.S citizens’ by assuring them safe and secure drugs as well as biologics. However, the […]
November 11, 2016

What Are The Phases Involved In A Clinical Trial?

Clinical trials are conducted for collecting data related to safety as well as the efficacy of new drug along with device development. There […]
November 8, 2016

Tips on Writing an Effective RBM Plan!

With risk based monitoring gaining importance in the clinical trials and with the release of the FDAs directives, it has become imperative to […]
November 7, 2016

How to Solve the Most Common Problems with Clinical Research?

Every year, millions of dollars are invested by pharmaceutical research and development companies due to clinical trial failures. All the capital invested on […]
November 4, 2016

The History of Clinical Research!

Each and every drug that is made available to the public in the market necessarily undergoes certain testing procedures. This process of medical […]
November 1, 2016

What Are The Biggest Biosimilar Challenges?

The term biosimilar refers to a pharmaceutical drug that is similar to an originally approved biological product with significant differences in safety and […]
October 31, 2016

Centralized or On-Site Monitoring – Which is a Better Approach for Risk Based Monitoring?

In the nascent stage of Risk Based Monitoring, it started on-site. But, with the passage of time, the focus shifted towards centralized monitoring. […]
October 27, 2016

Difference between AE and SAE in a Clinical Trial!

Clinical trials can result in several complications related to the medical conditions of the participants involved in a clinical trial. During a clinical […]