Blog

Stay informed with insightful articles on pharmaceutical research and development. Learn about our latest learning initiatives, course launches, special offers and much more.
Software used in Pharmacovigilance

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

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....

Electronic Data Capture

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. The CDISC defines Electronic Data Capture (EDC) as: “Collection...

Processes before Clinical Data Submission

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 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

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

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...

Regulation Governing Computer Systems in Clinical Trials

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...

Oracle Argus Safety 8.1.1 – Whats new!

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...

Oracle Clinical Overview

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

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

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

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...

Drug Development Process

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

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...

Follow Along

We would love to stay connected with you. Get new articles, learning content, industry insights and special offers right in your Inbox.

Ready to get started?

Get in touch, or enroll in a course