Saturday, March 6, 2021

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Clinical data management

CRASH COURSE ON CLINICAL DATA MANAGEMENT

Specially designed Course for Freshers and entry Level Professionals on Clinical Data Management  is going to be held 29 Nov (Sunday) from...

Interview Questions on Institutional Review Board(IRB)

“The Institutional Review Board (IRB) also known as an Independent Ethics Committee (IEC), Ethical Review Board (ERB), or Research Ethics Board (REB),...

Introductory Session on Clinical Data Management

Hello everyone, Introductory Session on Clinical Data Management for Freshers is going to be held on Aug-30-2020 (Sunday)...

Institutional Review Board

"The Institutional Review Board (IRB) also known as an Independent Ethics Committee (IEC), Ethical Review Board (ERB), or Research Ethics Board (REB),...

Free Course on Clinical Data Management

Freshers and job seekers  often search for clinical data management courses and they are ready to pay a good amount but this...

Basics of case report form

"Case report form (CRF) is designed to collect the patient data in a clinical trial as per the clinical trial protocol"

CLINICAL RESEARCH

Terminologies of Clinical trial terms

Adverse Event "A undesirable change or medical occurrence that occurs during a clinical trial or within a certain time...

What are Cancer biomarkers?

"Cancer biomarkers (CB) are biomolecules produced in response to the tumour by either the tumour cells or other cells within the body....

What are Biomarkers? What are the types of Biomarkers?

According to the National Cancer Institute, a biomarker is “a biological molecule found in blood, other body fluids, or tissues that is a...

Medical writing

Clinical Study Report

“A clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of...

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scientific writing

Difference Between Medical Writing and Scientific Writing

There are different views on using these two terms- medical writing and safety writing. Hence we tried to put some light on...

Impact Factor

Since a long time, Impact factor (IF) has been used as a key indicator of importance of a journal in a...

Let’s learn how to write an ABSTRACT

What you need to include in a research paper is ABSTRACT: ...

Lets learn how can You summarize any Story/ article or Research Paper

What is summarizing: Giving a short statement of the important points by removing all extra fat. Why is it important: It allows...

Pharmacovigilance

Pharmacovigilance Interview Questions 2020

We have written this blog especially for freshers after consulting many job aspirant who has experienced interviews in PV recently (in 2019-20)....

Two days Crash-Course on Pharmacovigilance

Specially designed Course for Freshers and entry Level Professionals on Pharmacovigilance is going to be held On 10 Oct (Saturday): 04:00-06:00pm and...

Development Safety Update Report (DSUR)

"DSURs are new, globally harmonised safety documents (which became obligatory in the Member States of the European Union in September 2011) covering...

regulatory affairs

Drug Approval Process in China

The National Medical Products Administration (NMPA) ( Chinese name translation in English “State Drug Administration” or China Food and Drug Administration CFDA) ...

Approval pathways of Fixed dose combination (FDC) in India

Fixed dose combination (FDC) approval process is a little different from the drug approval process in India. ...

Drug Approval Process in India

Regulatory Bodies for Drug approval in India The Drug and Cosmetic Act 1940 and Rules 1945 was enacted...

Orphan Drug Designation in US, EU and Japan

Orphan Drug Designation in USA: There are two routes (criteria) for obtaining orphan designation of a drug and...

The Drug approval process in EU:

50 regulatory authorities from the 31 European Economic Area (EEA) countries (28 EU Member States, including Iceland, Liechtenstein and Norway), the European Commission and...

HEOR

centralized monotoring

Centralized Monitoring in Clinical Trial

"The FDA definition of centralized monitoring states that it: "Consists of a remote evaluation performed by sponsor personnel or representatives (e.g., clinical...

Clinical researh associate

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...

Clinical Research Associate: Role, Responsibilities, Skills, and Salary

Introduction: Clinical Research Associate may be employed directly by the sponsor companies of clinical trials or by ...

clinical coding

What is Medical Coding?

"Medical coding is the transformation into necessary medical alphanumeric codes of healthcare diagnoses, treatments, medical facilities, and supplies. The...

LATEST ARTICLES

FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

March 05, 2021: "The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by...

EMA issues advice on Lilly’s bamlanivimab with etesevimab for confirmed COVID-19 in EU

March 5, 2021: "Eli Lilly and Company announced that the EMA Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion...

MHRA says modified COVID-19 vaccines for variants to be fast-tracked

March 04, 2021: "Authorised COVID-19 vaccines that are modified in response to new variants will not need a brand new approval or “lengthy” clinical studies,...

Co-WIN Covid-19 vaccine registration prosess

Co-WIN Covid-19 vaccine registration: The registrations for the Covid-19 vaccine registration opened from 9 AM on March 1 till 3 PM every...

Rotavirus vaccines made available for use in humanitarian crises

March 04, 2021: "Médecins Sans Frontières (MSF), Save the Children, UNICEF and the World Health Organization (WHO) welcome the opportunity to make...

ConserV Bioscience and LLNL to Collaborate on Development of Coronavirus Vaccine

January 19, 2021: ConserV Bioscience Limited (“ConserV”), a clinical-stage biotechnology company focused on developing vaccines that protect against endemic and emergent infectious...

Who can take the Pfizer-BioNTech COVID-19 vaccine?

"WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has issued its policy recommendations for the rollout of  the first COVID-19 vaccine approved for...

First JAK-Inhibitor Baricitinib Demonstrate for Hair Regrowth in Phase 3 Trial

March 3, 2021: "Eli Lilly and Company and Incyte announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety...

US court decision favours Symbicort in patent litigation

March 03, 2021: The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation...

ERS Genomics licenses CRISPR gene editing technology to Otsuka Pharmaceutical

March 03, 2021: "ERS Genomics Limited, which was formed to provide broad access to foundational CRISPR/Cas9 intellectual property today announced the signing...

Idorsia submits European marketing authorisation application of daridorexant for insomnia

March 3, 2021: "Idorsia Ltd announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for daridorexant,...

AstraZeneca advances mass global rollout of COVID-19 vaccine through COVAX

March 02, 2021: "The first of many millions of doses of AstraZeneca’s COVID-19 vaccine have begun arriving in low and middle-income countries...

Other

Tools Used in Writing Thesis and Research paper

"If you are a student or a researcher or a scholar, then you should use some tools that will help you focus...

What is the process for Submission of Synopsis?

1.1 a. "Prior to submission of a thesis synopsis, a comprehensive assessment of the research work should be carried out by a...

What Is a Synopsis? What is the Process for Submission of Synopsis?

"A synopsis is a brief summary that gives audiences an idea of what a composition is all about. The...

What Is a Blockbuster Drug?

What Is a Blockbuster Drug? "Blockbuster drugs are those that generate at least $1 billion of revenue per...