Industry Certificate in Clinical Data Management (CDM)

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 programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Data management as their career choice.

After completion of this programme, 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.

Programme Modules :

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: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

Module 14: Case Studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

Minimum duration to complete this programme is 3 months and maximum is 6 months.

Registration

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.

Programme Deliverables

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.

• – Assignments for all the programme modules for continuous evaluation and guidance.
• – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• – All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on 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 programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Industry Certificate in Clinical Data Management by Faculty of Clinical Research, 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 webpage as well.

Placement Assistance & Corporate Relations

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 like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Bliss GVS Pharma, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, Mankind, Beryl Drugs, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.

Future career prospects of Clinical Data Management Programmes

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 programme 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.

Download Prospectus

Programme Fee Details

How to apply

Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like