The Faculty of Clinical Research and Drug Safety (FCRDS) has been established as a constituent faculty of ‘Institute of Good Manufacturing Practices India’ (IGMPI), registered as a non-profit society (under The Societies Registration Act, 1860) with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. The FCR is dedicated to provide an easy to comprehend platform for education, training and exchange of information for clinical research professionals thereby fostering professional excellence in designing and execution of clinical research with expanding the knowledge base in core areas such as in clinical research, medical writing, pharmacovigilance and drug discovery and development.
India is fast becoming the preferred destination for clinical research for MNCs owing to relatively low cost of manpower, IT strengths in data management, qualified pharma professionals in drug discovery and development, pool of qualified doctors in medical writing, pharmacovigilence and overall study conduct, conformity to quality guidelines and high incidence of infectious and lifestyle diseases. Clinical trial industry is projected to become one billion dollar revenue industry as per Mckinsey report 2007.India is set to grab clinical research business over double the current level by 2016 as per international business and research consultancy firm Frost and Sullivan.
However there is enormous crunch of technical personnel with specific skills to match the requirements of this vast growing clinical research industry and pharmaceutical R&D as revealed in different surveys. The need of the day is to generate quality work force to cater to the needs of the clinical research industry and pharmaceutical R&D sector at various tiers.
The Faculty of Clinical Research and Drug Safety (FCRDS) is dedicated for providing education and training, news updates through newsletters covering national and international news and analysis on all aspects of drug discovery and development, clinical research, medical writing and pharmacovigilence. FCR is guided by brilliant, dynamic faculty members trained in various top CROs, SMOs and pharmaceutical industries possessing cutting edge technical expertise/skills and dedicated to teaching and research allowing new industry integrated programmes in drug discovery and development, clinical research, medical writing and pharmacovigilence.
The FCRDS team of technological experts has launched a high profile multi-tiered program to cater to the needs of knowledge intensive biotech /biopharma/ health care industry at different levels of employment, as well as that of academics. The FCR team of technology experts and other Industry advisors together pursue to make knowledge in drug discovery and development, clinical research knowledge, medical writing and pharmacovigilance training in the area of Pharma and healthcare easily accessible, through this platform.
The Institute of Good Manufacturing Practices India, registered under SR Act XXI of 1860, Government of India, recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.
Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food & Nutraceutical industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.
IGMPI is recognized by the Ministry of Commerce & Industry, Government of India and duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: ERO/EOMSM/L-8000027) for offering education and training programmes, services and processes in the areas of Pharmaceutical, Food, Nutrition, Healthcare, Environment Health & Safety (EHS), Environmental Social & Governance (ESG) and Marketing Communications.
Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.
The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:
IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.
IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.
IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).
Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.
Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.
For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.
IGMPI is an Institutional Member of the International Society for Quality in Health Care
Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.
National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.
Clinical data management (CDM) is the field which transforms raw data into consistent, accurate, reliable, meaningful trial output at a fair price. It aims to ensure data quality, integrity, and compliance with protocols and regulations. Clinical research employs a technique of Clinical data management to provide reliable and high quaity data from clinical trials. CDM makes sure that the study’s findings are supported by data that has been collected and stored. Rising number of clinical trials worldwide is anticipated to drive steady growth in clinical data management systems (CDMS) market by 2030. CDM market size is valued at 2164.88 Million in 2022 and this is predicted to increase to 6399.82 Million by the year 2031 at a 13.2% CAGR during the forecast period for 2023-2031.
Market growth is likely to be boosted by the expanding healthcare sector and the rapid advancements in the pharmaceutical industry. Product adoption has been driven by the increasing use of clinical data management systems by CRO’s and medical device manufacturers to maintain track of clinical data. Pharma Company’s needs effective data management for stringent process assurance, which helped the clinical data management systems market grows favourably in recent years. Trusworthy clinical trial data reduce cost, time and risk.
The Clinical Data Management Systems Market is segmented on the basis of Delivery Mode and End-use. Based on Delivery Mode, the market is segmented as Licensed Enterprise Solutions, Cloud-based Solutions, and Web-hosted Solutions. Based on End-use, the market is segmented into Contract Research Organizations, Medical Device Companies, and Pharma/Biotech Companies.
The Cloud Segment Is Accounted As A Major Contributor In The Clinical Data Management Systems Market. With the introduction of Virtual Clincal trials, the cloud segment's market share will rise. The cloud based technique provides better data management, a lower chance of data loss, and less concern for regulatory compliance. This will lead to increasing demands of cloud- based solutions by organizations.
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 programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Data management as their career choice. The major Key Players are ORACLE, IBM, CLINDEX, Ennov, Clinical, Veeva.
Module 1: Introduction of Clinical Data Management
Module 2: Basics of Clinical Trials (Its Stakeholders : Roles and Responsibilities)
Module 3: Guidelines for Clinical Data Management
Module 4: Data Management Plan(DMP)
Module 5: Review and Finalization of study documents
Module 6: Electronic Data Capture
Module 7: Database designing (CRF and IXRS)
Module 8: Data Entry, Data collection & CRF Tracking
Module 9: CRF Processing & Inventory from site
Module 10: Data Validation
Module 11: Discrepancy Management
Module 12: Database locking and Unlocking
Module 13: QA/QC checks in CDM
Module 14: Data storage and Archival
Module 15: Tools for CDM
Module 16: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))
Module 17: Industry Based Case Studies
BTech/Bsc in Biotechnology/ Microbiology/ Botany/ Zoology/ B.Pharm/M Pharm/MSc / MBBS/ BDS/ BHS/ BUMS/ BAMS/ Graduation in Life science disciplines are eligible for the programme.
The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).
The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma and Executive Diploma. 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 appear for an online proctored exam at the end of the programme. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Clinical Data Management, by IGMPI. For all the above-mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the web page as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.
In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like PPD, Infosys, The Emmes Company, Aster Zeneca, MPREX Healthcare, IQVIA, Syneos Health, Parexel, PRA Health Sciences, ICON, Labcorp, Tata Consultancy Services, Accenture, Cognizant Technology Solutions, Novartis, Syneos Health, Novo Nordisk, Indegene, iMedglobal, Lotus Labs, Aris Global, ClinicVA Healthcare Solutions, Accenture, Apollo Hospital, Bayer, Eli Lilly and Company, Ranbaxy, Genpact, GlaxoSmithKelvin, Infosys, The Emmes Company, Astra Zeneca, MPREX Healthcare, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.
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. Not only in India you have scope in U.S., Canada, U.K., Germany, China, Japan, Brazil, Mexico, South Korea, South Eaast Asia.This programme ensures a professional career in the clinical research industry as a Case Report Designer / Clinical Data Quality Assurance/ Quality Control/ Clinical Data Associate, Team Lead, Project Managers in pharmaceutical/biotechnology sectors, CROs, etc.
For further enquiries:
Write to :
info@igmpi.ac.in
Faculty of Clinical Research and Drug Safety (FCRDS)
18001031071 (Toll Free), Phone: +91 11 26512850
C-6, Qutab Institutional Area, Near Old JNU Campus, New Delhi-110016
18001031071 (Toll Free), Phone: +91 11 26512850