Significance of Clinical Management
Clinical data management places an essential role in the data collection phase of clinical research. The process of collecting research data is done in accordance with regulatory standards to obtain quality information that is completely error free. The aim of this field is to gather information that is both errorfree and complete in order to conduct analysis
Rising demand of Clinical data management
The field of clinical data management has come about due to demand from both the pharmaceutical industry and the regulatory authorities. Since there is an acceleration in the products of pharmaceutical products, regulatory authorities have made it necessary for quality-assurance standards be met in collecting the data that was used in the drug evaluation process.
Working of Clinical Data Management
The clinical Data Management (CDM) process starts at the very beginning of a clinical trial, to maintain the integrity of data . This takes place even before the study protocol is finalized in the process of the clinical trial. The CDM team designs a case report form (CRF) and defines the data fields to be utilized. CRFs specify the type of data to be collected, the units of measurement to be used, and CRF completion guidelines (i.e., instructions for filling in data).These Variables are annotated using coded terms.
A data management plan (DMP) is then developed as a guide, including a description of the trial’s Clinical Data Management (CDM) activities.These Databases are built to support CDM tasks with corresponding compliance tools. Testing is done before using the plan with actual clinical trial data. CFR tracking, data entry, validation, discrepancy management, medical coding, and database locking are subsequent steps in the process. Thus, clinical research management is important and therefore is included in clinical research courses.
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Key members of Clinical Data Management
The team members of Clinical Data Management perform a variety of roles and responsibilities . They are:
- Data Manager
The Data manager supervises the process of C:inical Data Management
- Database programmer or designer
The Database programmer or designer:
- performs the Case Research Form annotation
- Creates the database of the study
- Enables data validation
- Designs data entry screens
- Performs edit checks
- Medical Coder :
The role of a medical coder is to code variations such as adverse events and medical history into coded language.
- Clinical Data Coordinator
The Clinical Data Coordinator designs the Case Research Form, prepares the filling instructions and develops discrepancy protocols
- Quality Control Associate: This member checks the accuracy of data entry and performs data audits.
- Data entry associate : The Data entry associate tracks the Case Report Form Pages and enters data into a database
To conclude, Clinical Data Management plays an important role in the field of clinical research. Since, there are a number of developments in clinical research due to the prevalence of various diseases such as cancer and diabetes. As clinical research professionals have important responsibilities to carry out. Therefore, it is essential to pursue clinical research courses to become qualified clinical data management professionals.
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The recent report titled as “Global E-Clinical Solutions Market research report, published by Value Market Research, is designed to offer various market framework such as market size, portion, trends, growth path, value and factors that impact the current market dynamics over the forecast period 2020-2026.
Most importantly, this report also provides the latest significant strategies adopted by major players along with their market share.The research report also covers the comprehensive profiles of the key players in the market and an in-depth view of the competitive landscape worldwide.
The major players in the e-clinical solutions market include IBM Watson Health, Oracle Corporation, Medidata Solutions Inc., BioClinica, Datatrak International, Inc., PAREXEL International Corporation, CRF Health, ERT Clinical Solutions, OmniComm Systems Inc., Merger healthcare Incorporated, NextGen Healthcare.
The digital transformation in the field of clinical trials and emerging preference for data-centric approach provides a significant push to the growth of the market.
Furthermore, the increasing trend of outsourcing clinical trials to contract research organizations (CROs) coupled with constant technology advancement to improve its efficiency is expected to create a lucrative opportunity for the key players in the coming years.
The report covers Porter’s Five Forces Model, Market Attractiveness Analysis and Value Chain analysis.
