Clinical Data Management System Professional training
Price On RequestDescription:- Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Course Include Clinical Research, Clinical Trial, Pharmacovigilance, Clinical Data Management and Medical Writing 1/5Clinical Data Management Courses Training OnlineEnquiry Form Clinical Data Management Professional Company Connect Consultancy offers top quality courses in clinical research, Clinical Data Management and Data Analysis with strong emphasis on practical training and projects. Company Connect Consultancy aim to provide an efficient integration of academic knowledge and industry oriented expertise. We ensure to provide assistance for freshers to enter into the clinical research Industry , as well to the professionals who wish to achieve excellence at their professional world. All clinical research and clinical data management courses offered by Company Connect Consultancy are top quality and job oriented . The certificate Program in Clinical Research and Clinical Data Management and SAS provide students more opportunity to build a successful career In Clinical Research, CDM and SAS industry .We help the students to prepare their CV. Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in Clinical Data Management. Clinical Data Management Section 3 of Pharmacovigilance Course
Module 1.Clinical Trail Process and Design
Module 2.ICH-GCP and GCDMP
Module 3.Clinical Data Management Systems
CRF Design
Data Entry Data Collection
Data Load/Transfer
Data Storage
Data Validation
Data Export (SDTM)
Query Management
Data Archiving
Module 4.Project Management
Module 5.Security Systems
Practical Training will be also Provided on Oracle Argus Safety Database on the Following Topics:
Case processing
MeDRA coding WHO DD coding
Duplicate Check and case initiation
SAE Narrative writing