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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...

What is Phase-III Clinical Trial?

"Phase III trials are conducted to confirm and expand on the safety and effectiveness results from Phase I and II trials, to compare the drug to...

Most Read

AZ’s Tagrisso scores priority review from FDA with EGFR-mutated lung cancer

October 20, 2020: "AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in...

Forxiga recommended for approval in the EU by CHMP for heart failure

October 19, 2020: "AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the...

AstraZeneca advances leadership in renal disease at ASN Kidney Week 2020 Reimagined

October 20, 2020: AstraZeneca will present 84 abstracts, including 12 oral presentations and three late-breaking abstracts, across its industry-leading renal portfolio which...

AbbVie’s VENCLEXTA® Receives FDA Approval for Acute Myeloid Leukemia

October 16, 2020: "AbbVie announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination...