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.
Benefits of the Pharmacovigilance Course in Pune
CDM professional works in close liaison with other study management functions, responsible for screening through messages that have been received over the night globally. These data requires validation to new data, raise queries and questions, review responses to queries from sites etc. They are also actively involved in reviewing protocols, plan resource requirements, and discuss timelines and safety issues.
Benefits of the Pharmacovigilance Course in Pune
This six month course presents and emphasizes on methods to support planning, collection, storage, and dissemination of data in clinical research at a very high level including practical and conceptual way along with the application of GCP guidelines. Drug information association (DIA being our content developer offers a strong linkage program, for designing and developing the curriculum making industry ready professionals. DIA along with Dysmech Clinical Services Pvt Ltd (DCS) develops and implements educational programmes in professional trainings for domain expertise in the Clinical Research industry maintaining the highest standards for credibility and integrity. Students will get International certification which is globally acclaimed. We focus on practical lessons, assessments and hands-on exercises as we explore together best practices for data management for understanding and implementing solid data management principles. DCS is one of the best training cum soft skill educational organization in the Clinical Research Industry covering all the aspects and sectors of the same providing international certification for these courses and programmes in Pune.
Course Objectives and Gals
At the end of this programme one would be
• Thorough with the concepts and processes involved in CDM
• Become expert or proficient by acquainting knowledge and skills required to start career in CDM domain understanding their roles and responsibilities
• Guidelines associated with CDM and hands on practical exposure on software like Oracle Clinical/Rave/Inform etc
• Well Equipped with main aspects of CDM like CRF Designing, Data entry, Data Collection, AE Management, Report Creation etc.
Eligibility Criteria
- Doctors (MBBS/ MD/ BDS/ BAMS/ BHMS)
- Pharma Candidates (B. Pharm / M. Pharm)
- Life Sciences (M.Sc. / B.Sc)
Fresher and experienced clinical research personnel.
- Credits/sessions: 48
- Hours per session/credit: 3/5 in weekdays or weekends respectively. Each Session is explained in detail with the help of examples, flowcharts , illustrations and presentations.
After 3-4 months of the course as per students’ performance and scorecard. Eligible for a support amount monthly during the internship
DCS in Placement Preparation Program, trains all students for facing interview and selection process or procedures of the corporate world like Writing Skills, Communication Skills, Interview Skills and other aspects.100% placement assured for all successful candidates per students’ performance and scorecard
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