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Clinical Research
Principles of Good Clinical Practices
Principles of Good Clinical Practices Principles of Good Clinical Practices - Role of the FDA In this post we will discuss about the basic principles of Good Clinical Practices and how they apply to clinical trials. Before discussing the Good Clinical Practice...
Oracle Siebel Clinical Overview
In this post we will be providing an overview of Oracle Siebel Clinical and how organisations use Siebel clinical to manage their clinical trials more efficiently and effectively. Learning Objectives - Oracle Siebel Clinical By the end of this post, you should be able...
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
SOP for Data Entry in Oracle Clinical
SOP for Data Entry in Oracle Clinical A SOP (Standard Operating Procedure) in clinical trials is a documented set of procedures and instructions that describes how specific tasks or activities are to be carried out in a clinical trial. It provides a standardized,...
Oracle Clinical and RDC upgraded to 5.4.0
Oracle Clinical and RDC upgraded to 5.4.0 We have been offering Oracle Clinical and RDC 5.0.1 software access as part of our Clinical Data Management and Oracle Clinical courses, as well as through our Oracle Clinical - software access subscription service. This has...
Electronic Data Capture
Electronic Data Capture is one of the new technologies have impacted the process of clinical data management and have been well accepted to ensure a more efficient and effective method of data collection. Electronic Data Capture Overview The CDISC defines Electronic...
Processes before Clinical Data Submission
Processes before Clinical Data Submission In this post we shall be discussing about the clinical data management processes and tasks performed before the submission of clinical data to the regulatory authorities. These are basically divided in Data Extract and Data...
Clinical Data Management – Processes after Data collection
Clinical Data Management - Processes after Data collection Clinical Data Management - Processes after Data Collection. After all the data has been collected and the Last Patient Last Visit (LPLV) has been completed, it should be made sure that all the discrepancies...
Clinical Data Management – Processes during Data Collection
Clinical Data Management - Processes during Data Collection Clinical Data Management - Processes during Data Collection. Once the CDMS has been installed and the configured and after the systems have been validated, the process of data collection can begin. The...
Clinical Data Management – Processes Before Data Collection
Clinical Data Management - Processes Before Data Collection Clinical Data Management - Processes Before Data Collection. A good data management method involves the defining of processes for collection of data and its management even before we begin to collect data....
Oracle Clinical Overview
Oracle Clinical Overview Oracle Clinical Overview and its use in Clinical Data Management Oracle Clinical Overview - Oracle Clinical provides the life science industry the most integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) application on the...
Clinical Data Management Systems
Introduction to Clinical Data Management Systems (CDMS) In this article we shall discuss about the overview of clinical data management systems, their origin, definition of a CDMS and its components. This will give you a broad understanding about the use of Clinical...
Clinical Data Collection Methods
Methods of Clinical Data Collection Clinical Data Management requires the collection of raw clinical data. Data collection methods are of three types: Paper-based methods Electronic methods Hybrid methods Paper-Based Methods Paper based methods involve collection of...
Introduction to Clinical Data Management
Introduction to Clinical Data Management The various phases of drug development we talked about in previous blog posts, churn out enormous amount of clinical data which needs to be processed, stored, cleaned and analyzed and finally submitted to the regulatory...
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
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...
History of Pharmacovigilance
In this post we discuss about the History of Pharmacovigilance, its definition and the events that led to the need for pharmacovigilance. Old Definition of Pharmacovigilance Pharmacovigilance is the detection in the community of drug effects, usually adverse....
Good Pharmacovigilance Practices
In this post we will learn about Good Pharmacovigilance Practices which includes its background, good reporting practices, Characters of good report forms, Developing a case series as well as Pharmacovigilance plan and Pharmacoepidemiology. Introduction to Good...
Software used in Pharmacovigilance
In this post we shall be discussing about some of the common Software used in Pharmacovigilance for the management and reporting of Adverse Events. Introduction to Pharmacovigilance Pharmacovigilance is the pharmacological science relating to the detection,...
Overview of Pharmacovigilance
In this post we shall discuss the Overview of Pharmacovigilance. This should help you understand the key terminologies associated with this field and provide you the basic knowledge to explore this domain. So let us start with the Overview of Pharmacovigilance....
Medical writing
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...
Statistics in Medical Writing
Statistics in Medical Writing In this post, we shall discussion about the significance of Statistics in Medical Writing. We shall look at the components of statistics, the types of data and errors that are commonly encountered while computing them. We shall also learn...
Good versus Poor Scientific Writing
Good versus Poor Scientific Writing In this post, we shall identify what good scientific writing is what is the difference between Good versus Poor Scientific Writing. Its goals and elements will also be explained along with some common myths and misconceptions. Good...
Periodic Safety Update Reports (PSURs)
Periodic Safety Update Reports (PSURs) In this post we shall discuss about Periodic Safety Update reports (PSURs). in this post we will cover the following topics: Origin The origin of PSUR stems from the following: 1992 - "International Reporting of Periodic Drug...
Introduction to Medical Writing
In this post we shall provide an Introduction to Medical Writing, its types and scope in today’s medical world and the in the clinical research industry. Introduction to Medical Writing Medical writing is defined as communicating clinical and scientific data for a...