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Clinical Research
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
Introduction to Regulations Governing Computer Systems in Clinical Trials The FDA considers the pharmaceutical companies that conduct trials to be self-regulated. However it checks these pharmaceutical companies for compliance. Thus the FDA does not look out for how...
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
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 signifies works towards conducting the...
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 development involves the testing of a...
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 and Development
Origin 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 manager. Today, computers have become essential for storing, transmitting and managing information....
Clinical Data Management
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 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 have been resolved and all queries for any data sent out to...
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 process usually initiates with the CRFs coming in from the sites...
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. The processes involve identifying how data needs to be...
Oracle Clinical Overview
Oracle Clinical Overview and its use in Clinical Data Management Oracle Clinical provides the life science industry the most integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) application on the market. It was built based on hundreds of companies...
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
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....
Oracle Argus Safety 8.1.1 – Whats new!
Oracle Argus Safety - 8.1.1 - New Features Oracle Argus Safety 8.1.1 was officially few months back, so we thought we would share a question that came up recently from one of our prospective students who wanted to pursue a program in Pharmacovigilance and learn the...
Medical writing
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 Safety update summaries" (Council for...
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...