Blog Category: News Articles

Understanding the CRO Selection Process

Understanding the CRO Selection Process

Small emerging biopharma companies typically choose a contract research organization (CRO) based on several key factors, including expertise, capabilities, reputation, cost, and flexibility. Below is an overview of how these companies might go about selecting a CRO...

FDA Common Rule- A Much Needed Update

FDA Common Rule- A Much Needed Update

In a sweeping gesture to better protect human research subjects, sixteen US federal agencies issued a revised Common Rule on January 19, 2017, the first update since 1991.  The final rule, officially known as Federal Policy for the Protection of Human Subjects, aims...

FDA Releases GCP E6 R2 Guidance

FDA Releases GCP E6 R2 Guidance

Released by the International Council on Harmonisation (ICH) in November 2016, Good Clinical Practice’s second revision, R2 has been making waves in the clinical research industry. In March 2018, the US FDA released E6(R2) Good Clinical Practice: Integrated Addendum...

Clinical Research Conferences 2018

Clinical Research Conferences 2018

Which Clinical Research Conferences to Attend in 2018? Happy new year and welcome to 2018! As the clinical research industry continues to grow so does the plethora of educational opportunities and conferences that cater to our industry. Clinical Research is a very...

Mastering the Informed Consent Discussion

Mastering the Informed Consent Discussion

Overview of Informed Consent Informed consent is the process through which a potential subject is informed about a clinical research study and volunteers to participate. This typically entails a discussion with a member of the clinical research team or study doctor,...

Utilizing a Patient Recruitment Specialist

Utilizing a Patient Recruitment Specialist

The Patient Recruitment Specialist (PRS) is a fairly new and emerging role in the clinical research industry. Their role varies between trials and sponsors though their primary duty is to support clinical trial recruitment both globally and at the site level. The role...

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