Clinical Data Management (CDM) is a critical technique in clinical research with the help of which a statistically sound, reliable, and high-quality data can be generated from various clinical tests. After the collection of data from different clinical trials, these are analyzed and integrated at appropriate quality and cost. Clinical Data Management encompasses the entry, verification, validation, and quality control of data gathered during the conduct of clinical trials. The various steps in Clinical Data Management include Case Report Form designing, Case Report Form annotation, database designing, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking. The investors collect patient’s health data during the course of the clinical trial for a certain period of time. This data is then analyzed and pooled with the available data. All these data collected from the clinical examination will be stored in a Clinical Database Management System. A Clinical Database Management System consists of an analytical set of data.
Clinical Data Management is needed for various reasons of which most important reasons are:
1. Clinical Data Management is a critical phase in clinical research that leads to the production of high quality trustworthy and statistically sound data from clinical examination. These data help and expedite in the production of drug development including immediate marketing by industries.
2. Regulatory Agencies is dependent upon a trust that clinical trials data presented are of sufficient integrity to ensure confidence in the results and conclusions presented by Pharma Company and it is important to obtaining that trust is adherence to quality standards & practices hence. The major function of Clinical Data Management is to check that the collected data is complete and accurate. So, the results generated will be correct and used to check for the integrity and quality of the data that is being transferred from the trial system to the Clinical Data Management System.
Clinical Data Management is a relevant and important part of a clinical trial. All researchers working in the clinical research field try their hands-on Clinical Data Management activities at least once during their research period.
Overall, Clinical Data Managers are the one who are responsible for collecting data from a variety of medical research projects (clinical and pharmaceutical trials). They work collaboratively to make sure data is collected, managed and reported clearly, accurately and securely. While some clinical data managers work for large pharmaceutical companies, others work for hospitals, government organizations, or private companies and research universities. Preparing reports, statistical comparisons data manager and the research team, data charts and other presentation materials is an important part of the collaborative process.
Career Path For Clinical Data Associates
Generally, a Bachelor’s degree in life sciences, computer science, or healthcare is at least needed to be a Clinical data Associate. As this arena demands knowledge with computer science and in health care, you will be required to undergo training programmers to increase your awareness in record management, computer technology, and healthcare information systems. Despite the fact that it may or may not be a necessity, many companies prefer to recruit Clinical Data Associates with a master’s degree either in computer science or in healthcare disciple.
Nowadays most of the industries prefer to recruit experienced candidates as clinical data associates it is, therefore, necessary to gather experience of 1 or 2 years in the healthcare industry ideally in clinical data management. Participation in professional training in clinical data management with Oracle Clinical software can help in gaining experience and even such training may help appointment at entry-level after graduation.
Even though academic requirements on how to become a clinical data associate may differ from one organization to another, the nature of the job is such that aspiring clinical research associates mainly require clinical data knowledge especially oracle clinical software training. Specialized training in clinical data management such as a diploma or certificate course in clinical data management is an excellent way to crack into the industry and work as a clinical research associate.
Professional Training in clinical data management benefits an aspirant in obtaining recognition of competence, verification of expertise and specific competence, distinguish knowledge & skills, and professionalism, reliability, and dedication including assistance in professional growth. For a successful Clinical data Associate on must have the skills to compile, evaluate and examine data; ability to correctly apply data to clinical issues; must have a robust understanding of database coding aspects and clinical data management methods; side-by-side he should be able to handle several projects and ability to efficiently communicate findings to other clinical staff members.
Employment opportunities for clinical data associates are available usually in :
- Contract Research Organizations;
- Pharmaceutical Companies;
- Information & Technology Organizations;
- Biotechnology Companies and
- Government Departments.
Top Companies hiring frequently for Clinical Data Management Job Profiles are listed below:
- Cognizant
- PPD
- Novartis
- Novo Nordisk
- ICON
- Accenture
- inVentive Health
- IQVIA
- Pfizer
- CDSA