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Clinical Research

Software Expertise for Clinical Research Careers

Software Expertise for Clinical Research Careers

Leveraging Software Expertise for Clinical Research Careers Introduction The intersection of software expertise and clinical research has transformed the landscape of medical innovation. In an era defined by digital transformation, professionals with a strong command...

Job Opportunities in Clinical Research Industry

Job Opportunities in Clinical Research Industry

Job Opportunities in Clinical Research Industry Introduction The clinical research industry stands as a pivotal pillar in healthcare advancement, facilitating the development of new treatments, drugs, and medical procedures. With the rapid expansion of medical...

Exploring Clinical Research Trends in 2024

Exploring Clinical Research Trends in 2024

Exploring Clinical Research Trends in 2024: A Glimpse into the Future of Medicine Clinical research is the backbone of medical advancements, providing the evidence necessary to develop new treatments, improve existing therapies, and enhance patient care. As we step...

Wearables in Clinical Research

Wearables in Clinical Research

Wearables in Clinical Research Introduction In the dynamic landscape of healthcare, technology continues to revolutionize the way we approach clinical research. One of the most impactful innovations in recent years is the integration of wearables into the realm of...

Technology Integration in Clinical Trials in 2023

Technology Integration in Clinical Trials in 2023

Technology Integration in Clinical Trials in 2023 : Transforming the Future of Healthcare Introduction In the ever-evolving landscape of healthcare, clinical trials play a pivotal role in advancing medical knowledge and improving patient outcomes. In recent years,...

Digital Health Technologies and Remote Monitoring

Digital Health Technologies and Remote Monitoring

Advancing Clinical Research with Digital Health Technologies and Remote Monitoring Introduction Clinical research is the backbone of medical progress, driving innovation in healthcare and ultimately improving patient outcomes. In recent years, digital health...

Precision Medicine in Clinical Research

Precision Medicine in Clinical Research

Precision Medicine in Clinical Research: Revolutionizing Healthcare Introduction In the ever-evolving landscape of healthcare, precision medicine has emerged as a groundbreaking approach that holds the promise of personalized and more effective treatments. Unlike the...

Risk Based Quality Management

Risk Based Quality Management

Enhancing Clinical Trial Quality through Risk-Based Quality Management Introduction Clinical trials play a pivotal role in the development of new pharmaceuticals and medical treatments. Ensuring their success and reliability is paramount, not only for the health of...

Decentralized Clinical Trials

Decentralized Clinical Trials

Revolutionizing Clinical Research: The Promise of Decentralized Clinical Trials Introduction Clinical trials are the backbone of medical progress, providing essential data to bring new drugs and medical devices to market. However, the traditional model of conducting...

SOP for Clinical Research Management Plan

SOP for Clinical Research Management Plan

SOP for Clinical Research Management Plan Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and instructions for the development and implementation of a clinical research management plan. This plan ensures the efficient and...

Principles of Good Clinical Practices

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

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

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

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...

 

Clinical Data Management

Clinical Data Management Trends 2024

Clinical Data Management Trends 2024

Clinical Data Management Trends 2024 Introduction Clinical Data Management (CDM) stands at the forefront of healthcare innovation, ensuring that the wealth of data generated through clinical trials and patient care is harnessed effectively to drive medical...

How is SAS used in Clinical Trials

How is SAS used in Clinical Trials

How is SAS in Clinical Trials: Transforming Data into Lifesaving Insights Introduction The field of clinical trials is a cornerstone of modern healthcare, responsible for bringing innovative drugs and treatments to patients. To ensure the success and safety of these...

Emerging Technology Trends in Clinical Data Management

Emerging Technology Trends in Clinical Data Management

Emerging Technology Trends in Clinical Data Management Introduction Clinical data management plays a pivotal role in the healthcare industry by ensuring the accuracy, integrity, and security of patient data. As the healthcare landscape continues to evolve, driven by...

SOP for Data Entry in Oracle Clinical

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

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

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

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 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 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 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 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

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...

Designing a Clinical Study in Oracle Clinical

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...

 

Pharmacovigilance

Is pharmacovigilance in demand?

Is pharmacovigilance in demand?

Is pharmacovigilance in demand? Exploring the Demand for Pharmacovigilance: A Critical Analysis In the intricate world of pharmaceuticals, where every drug brings hope for better health outcomes, ensuring safety remains paramount. This responsibility falls under the...

10 Reasons to Learn Oracle Empirica Signal

10 Reasons to Learn Oracle Empirica Signal

10 Reasons to Learn Oracle Empirica Signal In today's data-driven world, pharmaceutical and life sciences industries are at the forefront of innovation, constantly striving to enhance patient outcomes, optimize operations, and ensure regulatory compliance. Amidst this...

11 Compelling Reasons to Learn Argus Safety

11 Compelling Reasons to Learn Argus Safety

11 Compelling Reasons to Learn Argus Safety Introduction In the realm of pharmacovigilance and drug safety management, Argus Safety stands out as a cornerstone software solution. Developed by Oracle, Argus Safety is a comprehensive platform designed to streamline the...

Navigating Pharmacovigilance Trends in 2024

Navigating Pharmacovigilance Trends in 2024

Navigating Pharmacovigilance Trends in 2024: Enhancing Drug Safety in a Dynamic Landscape Introduction Navigating Pharmacovigilance Trends in 2024. In the realm of healthcare, pharmacovigilance stands as a cornerstone for ensuring the safety and efficacy of...

Pharmacovigilance Market Growth in 2023

Pharmacovigilance Market Growth in 2023

Riding the Wave of Pharmacovigilance Market Growth in 2023: Numbers, Trends, and Outlook Introduction Pharmacovigilance, the science and practice of monitoring and assessing the safety and efficacy of pharmaceutical products, is a cornerstone of the global healthcare...

Pharmacovigilance Data management and Eudravigilance

Pharmacovigilance Data management and Eudravigilance

Pharmacovigilance Data management and Eudravigilance The Pillars of Drug Safety: Pharmacovigilance Data Management and EudraVigilance In today's fast-paced world, pharmaceutical companies are constantly striving to develop new drugs and therapies to improve human...

Emerging technologies in Pharmacovigilance

Emerging technologies in Pharmacovigilance

Exploring the Future: Emerging Technologies in Pharmacovigilance Introduction Pharmacovigilance, often referred to as drug safety surveillance, plays a critical role in ensuring that pharmaceutical products on the market are safe and effective for patients....

Signal detection and post authorization safety

Signal detection and post authorization safety

Signal Detection and Post Authorization Safety Ensuring Medication Safety Beyond Approval In the realm of pharmaceuticals, ensuring the safety of medications is an ongoing and multifaceted endeavor. While rigorous pre-authorization clinical trials are a crucial step...

Pharmacovigilance Workflows with AI & Automation

Pharmacovigilance Workflows with AI & Automation

Pharmacovigilance Workflows with AI & Automation Enhancing Drug Safety in the Digital Age Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays...

Big data and AI in pharmacovigilance

Big data and AI in pharmacovigilance

Big data and AI in pharmacovigilance Leveraging Big Data and AI for Safer Medicines: Revolutionizing Pharmacovigilance Introduction Pharmacovigilance, the science of monitoring and evaluating the safety of drugs, is undergoing a transformation driven by two powerful...

Patient-centric approaches in Pharmacovigilance

Patient-centric approaches in Pharmacovigilance

Embracing Patient-Centric Approaches in Pharmacovigilance Introduction Pharmacovigilance, the science and practice of monitoring and assessing the safety of pharmaceutical products, has evolved significantly over the years. Traditionally, this field primarily relied...

Pharmacovigilance in a Pandemic World

Pharmacovigilance in a Pandemic World

Pharmacovigilance in a Pandemic World: Ensuring Safety Amidst Crisis Introduction In a world marked by unprecedented global health crises, pharmacovigilance has emerged as a critical component in safeguarding public health. The COVID-19 pandemic, which swept across...

The Globalization of 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

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 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...

 

Medical writing

Trends in Regulatory Writing

Trends in Regulatory Writing

Navigating the Future: Trends in Regulatory Writing Introduction Regulatory writing is a crucial component of the pharmaceutical, healthcare, and biotechnology industries. It involves the creation of documents and reports that communicate complex scientific data and...

The Future of Medical Writing

The Future of Medical Writing

The Future of Medical Writing: Pioneering a Path to Precision and Accessibility Introduction Medical writing has long been a cornerstone of the healthcare industry, serving as the bridge between complex scientific research and the broader community of healthcare...

Guide to Narrative 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

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

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)

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

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...

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