Wednesday, June 23, 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

Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of OS and PFS

June 22, 2021: Merck known as MSD outside the United States and Canada announced that the pivotal Phase 3 KEYNOTE-826 trial investigating...

EU approve Koselugo for children with neurofibromatosis & plexiform neurofibromas

June 22, 2021: "AstraZenecaand MSD's Koselugo (selumetinib) has been granted conditional approval in the EU for the treatment of symptomatic, inoperable plexiform neurofibromas (PN)...

FDA Approves First Oral Blood Thinning Medication for Children

June 21, 2021: The U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years...

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

JUNE 22, 2021: "Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have...

Bayer and Zydus announce continuity of their successful Joint Venture

June 21, 2021: Bayer and Cadila Healthcare Limited announced the extension of their Joint Venture by three years from June 2021.

UN statement on renewal of humanitarian lifeline to millions of people in north-west Syria

June 18, 2021: "Millions of people are pressed up against the border in an active war zone in north-west Syria and remain in...

AstraZeneca welcomes Court ruling on supply of its COVID-19 vaccine to Europe

June 18, 2021: "AstraZeneca welcomed the ruling by the Court of First Instance in Brussels. The European Commission...

FDA Approves a Nasal Antihistamine for Non-prescription Use

June 17, 2021: "The U.S. FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription...

Lilly Launches Think Talk Treat Migraine™ to Help Improve Diagnosis and Treatment of Migraine

June 17, 2021: Based on results from a large population-based survey, it is estimated that approximately half of people with migraine hesitate...

CureVac’s COVID-19 vaccine CVnCoV misses the mark in late-stage study

June 16, 2021: "CureVac, a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”) announced...

Lilly Announces Head-to-Head Study Comparing Once-Monthly Emgality® with Every-Other-Day Nurtec® ODT for the Preventive Treatment of Migraine

June 15, 2021: To advance the science of migraine treatment and aid the understanding of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs)...

Scientists develop ‘game-changing’ antibody test to detect new variants

June 15, 2021: Antibody tests that can detect whether people have been exposed to new variants of Covid-19 have been developed by...

Other

GPAT 2021-Results-Announcement

 The National Testing Agency (NTA) has announced GPAT (Graduate Pharmacy Aptitude Test) 2021 on 19-Mar-2021 and you can access the result at below...

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...