Clinical Data Management is the fields which transform raw data into consistent, accurate, reliable, meaningful trial output in accordance with guidelines. Market is expected to grow to US$1.37 billion by 2015. Driving factors for growth of this segment are advancement in e-technologies, continuing technological advancements and globalization of clinical trials. CDM market size is considered to be >US$60 million growing at a rate of over 50%. There are over 150 organizations active in this segment.
Professionally trained personnel are required to sustain in such challenging environment. IGMPI provides theoretical as well as practical knowledge which provides assurance of sustainability and success in this industry.
The course is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Data management as their career choice.
Module 1 : Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders
Module 2 : Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions
Module 3: Introduction to Data Management
Module 4: CRF Design Considerations
Module 5: Data Entry, Remote Data Entry
Module 6: Identifying and Managing Discrepancies
Module 7: Data Management Plan
Module 8: Electronic Data Capture
Module 9: Tracking CRF Data
Module 10: Managing Lab Data
Module 11: Collecting Adverse Event Data
Module 12: Creating Reports and Transferring Data
Module 13: Case Studies
After completion of this course, students will have clear understanding on various essential elements of clinical data management, theoretical knowledge on regulatory guidelines, CDM work flow, data management plan, different activities involving CRF designing, data entry, data collection, AE management, report creation etc. along with roles and responsibilities of CDM personnel.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year Clinical Data Management program. The applicant must be a graduate in any discipline.
The course will be completed over a period of Three months which will include the tenure applicable for examinations as well as case studies completion.
The registration dates for this bi-annual program run by the institute are updated timely on the webpage. The Training sessions and webinars are strictly scheduled depending on the availability of speakers. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
A one-time fees (lump sum paid at beginning of the course) for distance cum e- learning mode is Rs. 1,10,000/-(3000 USD for overseas students) and 21,000/-(700 USD for Distance cum e-learning Mode) This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 450/- (USD 20) per module needs to be paid later as per the examination notification of the Institute.10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex-servicemen or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).
IGMPI follows a credit system based on all all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
All the participants are obliged to timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Post Graduate Diploma in Clinical Data Management by Institute of Good Manufacturing Practices India (IGMPI). For all the above mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.
Clinical Data Management (CDM) has long way with increased importance within and outside biopharmaceutical research and development. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. Major companies hiring clinical data management professionals are CTS, TCS, PPD, BMS, Pfizer, Accenture, ICON, Novartis, Quintiles, Parexel, Neeman Medical etc. This programme provides person, professional benefits such as sense of accomplishment, validation of CDM knowledge, recognition by company, ability to train others as well as assisting others and organizational benefits such as well trained and updated professionals, excellent professional development opportunities with increased efficiency and improved quality within the company. This course ensures a professional career in the clinical research industry as a Case Report Designer / Clinical Data Quality Assurance/ Quality Control/ Clinical Data Associate etc. in pharmaceutical/biotechnology sectors, CROs, etc.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like