Clinical Data Management eBook

Download Clinical Data Management eBook Clinical Data Management eBook icon

Clinical Data Management eBook

by: Kamal Akhtar

FREE DOWNLOAD 8.4 17

8.4 Users
rating

Screenshots

Description

Clinical Data Management - A Beginner’s Guide

Overview

Clinical Data Management (CDM) involves the process of collecting, storing, managing, analyzing, reporting, submitting and archiving clinical data generated from clinical trials which are conducted as a part of the drug development process, to ensure good quality, clean data that is fit for submission to the regulatory authorities.

About the Book

Clinical Data Management, A Beginner’s Guide is intended for students and enthusiasts willing to make a career in clinical data management.

The book first describes the processes involved in developing a new drug (drug discovery, pre-clinical development and clinical development) and then explains each of these processes in detail with special emphasis on computer systems and methods that are used for the same in the industry today.

The book is a resource on the following topics:

- Overview of R&D in the Pharmaceutical Industry
- Drug discovery process
- Phases of Drug development
- Overview of Clinical Data Management
- Methods of Clinical Data Collection and Management
- Clinical Data Management System (CDMS)
- Oracle Clinical – A Case Study
- 21 CFR Part 11 regulations
- Form and System Design
- Selecting, validating, installing and configuring a CDMS
- Patient Management
- Quality Assurance
- Handling AE’s and SAE’s
- Database Lock and Freeze
- Retention and Archival of Clinical Data
- Electronic Data Capture (EDC)
- Clinical Data Interchange Standards Consortium (CDISC)

Tags: clinical data management , oracle clinical screenshots , clinical data management inform , clinical data management comic , micromedex drugs information apk , ebook verwaltung , app clinical management , oracle clinical , micromedex drug information apk

Users review

from 17 reviews

"Great"

8.4

Users activity

Neelam

by Neelam

Downloaded

Лена

by Лена

Downloaded

Isafin

by Isafin

Downloaded

Outsourcedgeek

by Outsourcedgeek

Downloaded