Tuesday, May 11, 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

Sanofi establishes three-year collaboration with Stanford Medicine to accelerate immunology research

May 6, 2021: Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine. Together, the...

Imfinzi, tremelimumab combo boosts survival in lung cancer

May 07, 2021: "POSEIDON was a Phase III trial of AstraZeneca’s Imfinzi (durvalumab) plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in...

Vectura and Inspira Sign Agreement to Develop Potential Inhaled Treatment for COVID-19

May 06, 2021: "Vectura Group plc, an industry leading inhalation CDMO, and Inspira Pharmaceuticals Limited, a new UK-based company focused on developing therapies...

Nirsevimab MELODY Phase III trial met primary endpoint of reducing RSV lower respiratory tract infections in healthy infants

April 26, 2021: The MELODY Phase III trial for nirsevimab met its primary endpoint of a statistically significant reduction in the incidence...

Zydus ‘Virafin’ receives Emergency Use Approval from DCGI moderate COVID-19 infection in adults

April 23, 2021: Zydus Cadila announced that the company has received Restricted Emergency Use Approval from the Drug Controller General of India...

Amarin receives great britain authorization for vazkepa from MHRA

Apr 22, 2021:  "Amarin Corporation announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorization for VAZKEPA...

BMS Invests in Europe with New Cell Therapy Manufacturing Site Planned in the Netherlands

April 22, 2021:Bristol Myers Squibb announced the company has selected Leiden, Netherlands to house a new cell therapy manufacturing site in Europe,...

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

April 21, 2021: "The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously.

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

April 22, 2021: "The U.S. FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that...

WHO launches effort to stamp out malaria in 25 more countries by 2025

April 21, 2021: Ahead of World Malaria Day, marked annually on 25 April, WHO congratulates the growing number of countries that are...

Novo Nordisk to initiate phase 3a development in obesity with oral semaglutide

 April 21, 2021: "Novo Nordisk announced the decision to enter phase 3a development in obesity with oral semaglutide 50 mg.

Lilly and Incyte’s Baricitinib Improved Hair Regrowth for Alopecia Areata Patients

April 20, 2021: Eli Lilly and Company and Incyte announced results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety...

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...