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Clinical Research
Regulation Governing Computer Systems in Clinical Trials
Regulation Governing Computer Systems in Clinical Trials Introduction - Regulations Governing Computer Systems in Clinical Trials Regulation Governing Computer Systems in Clinical Trials. The FDA considers the pharmaceutical companies that conduct trials to be...
Drug Development Process
The Drug Development Process Once a compound (Drug candidate) is selected and patented, so as to secure space for innovation within the fast moving research arena, the compound has to undergo several stages of preclinical (animal) testing and clinical (human) testing...
Drug Discovery
Introduction to Drug Discovery Drug discovery is a research, but should not be confused with academic research. Most academic research involves researching on something for the sake of understanding and there is no final goal. However drug discovery has a focused...
Computers in Clinical Development
Computers in Clinical Development The use of Computers in Clinical Development has been evolving rapidly. The clinical development branches can broadly be categorized into two. Clinical Operations Clinical Data Management The Clinical operations team as the name...
Computers in Preclinical development
Computers in Preclinical development Computers in preclinical development has become an integral part of pharmaceutical research and development. Computers have found their importance as data management and data analysis tools in Pharmaceutical R&D. Pre-clinical...
Computers in Drug Discovery
Computers in Drug Discovery is now becoming mainstream. For over 40 years X –ray crystallography has been recognized as a standard for viewing three dimensional structures of proteins. This provides a detailed description of arrangement of atoms in a molecule, which...
History of Computers in Pharmaceutical Research
History of Computers in Pharmaceutical Research Origin of Computers in Pharmaceutical Research History of Computers in Pharmaceutical Research and Development. Twenty five years ago, one could not even imagine a computer at the desk of every scientist and company...
Clinical Data Management
Designing a Clinical Study in Oracle Clinical
In this post we shall discuss the process of Designing Clinical Study in Oracle Clinical using the Design subsystem. Before you read this post you may be interested in reading the process of Planning a Clinical Study in Oracle Clinical Already done that? Great. Let's...
Planning a Clinical Study in Oracle Clinical
Planning a Clinical Study in Oracle Clinical is the first step in clinical data management. It helps you define the key parameters of the clinical study as defined with the Protocol. The Planning of a clinical study within Oracle Clinical should start once the draft...
Oracle Clinical Program – Key Features
The Oracle Clinical program offered by ClinSkill is unique in several ways. We offer a breakthrough mechanism of learning that is self-paced, flexible, modular, practical and affordable. Let's have a look at what makes this program so unique. Online access to Oracle...
Pharmacovigilance
The Globalization of Pharmacovigilance
The Globalization of Pharmacovigilance: Safeguarding Health on a Worldwide Scale Introduction In our increasingly interconnected world, the pharmaceutical industry has undergone a significant transformation. Rapid globalization has not only expanded access to...
Powering Pharmacovigilance with Social Media
Powering Pharmacovigilance with Social Media The Rise of Social Media in Pharmacovigilance In an era defined by the rapid dissemination of information and the growing influence of social media, the field of pharmacovigilance has undergone a significant transformation....
Pharmacovigilance Jobs for Freshers
Pharmacovigilance Jobs for Freshers Pharmacovigilance is a crucial field within the pharmaceutical and healthcare industry that involves the monitoring, assessment, and reporting of adverse effects or any other drug-related problems associated with medications. If...
Dawn of AI in Pharmacovigilance
Dawn of AI in Pharmacovigilance: A New Era of Drug Safety Monitoring In the realm of healthcare, where precision and safety are paramount, the incorporation of artificial intelligence (AI) has emerged as a groundbreaking force, transforming various facets of the...
Individual Case Safety Reports (ICSRs)
Individual Case Safety Reports In this post we shall discuss about Individual Case Safety Reports (ICSRs). in this post we will cover the following topics: Introduction This post includes data elements of case safety reports for both pre and post approval periods and...
Oracle Empirica Signal upgraded to 9.2
Oracle Empirica Signal upgraded to 9.2 We have been offering Oracle Empirica Signal 7.3.3 software access as part of our Pharmacovigilance Signal Detection courses, as well as through our Oracle Empirica Signal - software access subscription service. This has allowed...
Oracle Argus Safety upgraded to 8.2.3
Oracle Argus Safety upgraded to 8.2.3 We have been offering Oracle Argus Safety 8.1.1 software access as part of our Pharmacovigilance and Argus Safety courses, as well as through our Oracle Argus Safety - software access subscription service. This has allowed...
Guide to Narrative Writing
This post is a Guide to Narrative writing that will help you understand the importance and various elements of Narrative writing. Introduction The idea of this guide is to introduce the newcomers to the basic writing principles. This is based on the initial writing...
WHO and Safety Reporting
WHO and Safety Reporting In this post we will talk about history, Present program structure, Current work, Guidelines and role of Uppsala Monitoring Centre in relation with WHO and safety reporting for adverse reactions. The WHO International Drug Monitoring Program...
Overview of MedDRA
Overview of MedDRA In this post we will learn about the Overview of MedDRA, its history and origin, MedDRA subscriptions, contents and uses of MedDRA. Introduction to MedDRA MedDRA is a registered trademark belonging to the International Federation of Pharmaceutical...
Qualified Person for Pharmacovigilance (QPPV)
Qualified Person for Pharmacovigilance (QPPV) This post will give you a brief understanding about who a QPPV is and what his roles ad responsibilities are. Introduction - Qualified Person for Pharmacovigilance (QPPV) In the European Union, the Qualified Person...
Audits and Inspections in Pharmacovigilance
Audits and Inspections in Pharmacovigilance Overview - Audits and Inspections in Pharmacovigilance This post describes how pharmacovigilance audits are performed, from the audit planning to writing an audit report. It gives an overview of several aspects of audit...
Post Marketing Surveillance
Post Marketing Surveillance Introduction to Post Marketing Surveillance The fundamental importance of safety and efficacy assessment throughout the drug development process has been emphasized many times. Efficacy is also considered throughout the drug development...
Signal Detection in Pharmacovigilance
Signal Detection in Pharmacovigilance Signal detection in Pharmacovigilance involves looking at the adverse reaction data for patterns that suggest new safety information and specifically whether the new information changes the benefit to risk ratio associated with...
Pharmacovigilance for Vaccines
Pharmacovigilance for Vaccines Pharmacovigilance for Vaccines, also known as Vaccine vigilance, is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of...
Medical writing
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