What is Clinical Data Management?
Clinical Data Management (CDM) is a predominate part in clinical research, resulting in reliable and statistically sound data of high quality from clinical trials.CDM deals with collection, integration and availability of data at appropriate quality and cost. The process encompasses the data entry, verification, validation, and quality control of data gathered during the conduct of clinical trial.
Regulatory Agencies are dependent upon this high quality data presented from clinical trials by data management tools and specialists which are of sufficient integrity to ensure confidence in results and conclusions presented by Pharmaceuticals companies and Contact research Organizations (CRO) adherence to quality standards
Clinical Data Management flow chart:
Steps Involved in clinical data handling is:
- Source data like are clinical site medical records, laboratory results, physical examinations, and patient diaries are generated.
- The clinical site records are transcribed onto the paper case Report Forms (CRFs) -or electronic data capturing systems (EDC)/ Electronic CRFs (eCRFs).
- Paper data CRFs, as well as other source data, are entered into the clinical trial database manually. eCRFs allows data to be entered directly into the database from source documents. Paper CRFs content and data are often reconciled and entered twice in order to minimize the error rate.
- Accuracy, quality, and completeness are reconciled in the data and problems are resolved. Queries are generated and sent to clinical site for proper accuracy. This step involves data validation where collected and reconciled data are validated to be error free. The data are considered final and eventually the database is locked. The data are analyzed and reformatted for reporting and analysis. Tables, listings, and figures are generated.
- Documents such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs), Product’s Information sheet etc are generated and integrated and generated likewise.
The database and other study data are archived and stored.
Clinical data Management Industry and career prospects upon completion and certification of the course
Clinical data management systems will strive high with large number of clinical trials in the pipeline and in the market and India being a hub for the same. Clinical trials are the only means of ensuring safety and efficacy of a novel drug as various regulatory bodies are imposing stringent regulation for approval of a drug in recent times. The number of clinical trials will increase and with government support and initiatives clinical data management systems industry will boost in the upcoming years.
An astute qualified or rich/expert/certified in Clinical Industry knowledge starts with approx 3 Lakhs salary package per anum and eventually the monetary part reaches high with knowledge ,expertise, position, designation as high as 15 Lakhs per anum or more.
Detailed career opportunities and scope are listed below
- Clinical data validation expert
- Clinical data validation Associate
- Clinical data Associate
- Clinical Data Manager
- Bio-statistician
- Software Developers and Programmers /Study builders
- Clinical data Cordinator/Data entry operator/Data Reviewer
- Project data Manager
- Senior Project data manager
- Project Manager and so on..
Top players in the Clinical research Industry are
Contract Research Organizations(CROs),Clinical Laboratories, Government Sectors, Biotechnology labs, Pharmaceuticals Companies, Pharmacovigilance industry, IT companies in aligned with Healthcare Industries, Hospitals, Regulatory Affairs Trial /Site management Organizations(TMO/SMO),Research and development Industries
Some of our placements parties are
Cipla,Accenture,Novartis,Cognizant,PPD,Ranbaxy,Paraxel,IGate,Sciformix,Fortis,Apollo,Infosys,Wipro,Merck,GlaxoSmithline etc
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