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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 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...
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 - 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 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...
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...