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Clinical Trial Protocol

"A protocol for clinical trials is a document outlining how a clinical trial should be performed, including the objective(s), design, methodology, statistical...

What is “Expanded access”?

"Expanded access, also referred to as "compassionate use," is a potential pathway for the patients with an immediately life-threatening disorder or severe...

Clinical Research Job Interview Questions and Answers 2020

This blog is written after consulting many interviewers and these are the common questions which are being asked in clinical research job...

Investigator Meeting: Planning to Success

"An Investigator Meeting is typically the responsibility of a sponsor, but this role can also be assigned to a CRO. For those...

Randomization in Clinical Trials: Definition and types

Randomization "As per the National Cancer Institute “In research, the process by which participants in clinical trials are assigned...

What is the electronic Common Technical Document (eCTD)?

Introduction: "The standard format for submitting submissions, modifications, supplements, and reports to the Center for Drug Evaluation and Research...

What is Clinical Trial Master File?

Introduction: "A trial master file is a collection of the important content for clinical trials that are overseen...

Placebo is?

"A placebo is anything that seems to be a "real" medical treatment -- but it doesn’t." What is Placebo?

Surrogate Endpoint (Marker): Definition and Examples

"As per National Cancer Institute : In clinical trials, an indicator or sign used in place of another to tell if a...

Informed consent in Clinical Research

"Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of the...

What is the Phase-IV Clinical Trial?

Phase IV trial is also known as post-marketing trial, or informally as a confirmatory trial. Phase IV trials include a drug's health...

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Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

April 21, 2021: A brand new oral treatment for an incurable blood cancer has been recommended for NHS use by NICE.

GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

April 20, 2021: "GW Pharmaceuticals, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicinesannounces that the European Commission has...

Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

April 16, 2021: "Amgen announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of...

JCVI issues new advice on COVID-19 vaccination for pregnant women

April 16, 2021: There have been no specific safety concerns identified with any brand of coronavirus (COVID-19) vaccines in relation to pregnancy.