Boston International Clinical School offers different well known Clinical Data Management courses in India. The school is heavy in applied, industry relevant training, usually in collaboration with other educational institutions. Studies take place both online and offline. Each new drug, vaccine, or medical device has to be tested out by way of clinical trials as safe and effective. But behind each trial is a vast ocean of data—patient data, lab data, test results, and regulatory documents.
India has become a world leader in Clinical Data Management services based on its pharmaceutical heritage, human resource base, and cost-saving offshoring model. CDM professionals are now among the most sought-after professionals in clinical research.
At Boston International Clinical School (BICS), we have realized the importance of having employment-based training in CDM. In this regard, we have incorporated Clinical Data Management specialization into our curriculum so that our students are well educated in theory but also well trained in practice with handling data.
What is Clinical Data Management (CDM)?
Clinical Data Management is a systematic collection, validation, cleaning, and analysis of clinical trial data to make it accurate and reliable for regulatory submission.
Major Activities of CDM
- Case Report Form (CRF) Design: CRFs are patient questionnaires for data capture while conducting trials. CRFs are designed and managed by the CDM personnel for taking accurate clinical information.
- Electronic Data Capture (EDC) Systems: Trial monitoring and electronic data entry are conducted with computer packages such as Medidata Rave, Oracle Clinical, and Inform. CDM personnel need to be sufficiently familiar with them.
- Data Validation and Query Management: Receiving data, CDM personnel perform error checks, discrepancies, or missing data validation. Corrections are requested to be resubmitted by trial sites.
- Compliance with Regulations: All clinical trials should be as per ICH-GCD (Good Clinical Practice), FDA, EMA, and DCGI. CDM makes trial data ready for submission.
- Database Lock & Reporting: Once cleaned, the trial database is "locked" and checked by biostatisticians to prepare final reports for drug approval.
The BICS Advantage in Clinical Data Management
- Linkage with Boston Clinical Trials (USA): Our students enjoy the first-hand experience of global trial data management practices, therefore are globally ready for career postings.
- NEP-Synchronized Flexibility: Certification in 1 year, diploma in 2 years, or full 3-year degree with specialisation in CDM.
- Industry Standard Tools Training: Practical experience in Medidata Rave, Oracle Clinical, Inform EDC, SAS Programming
- Internships with Pharma Companies and CROs: Internship is compulsory at BICS, thus the students are mature when they graduate.
- Emphasis on Integration of Data Science: As CDM is transforming with assistance from analytics and AI, we have incorporated Clinical Data Science in our CDM modules. This provides our students with an enhanced edge over the conventional CDM graduates.
Some of the skills gained by students in a CDM Course
- Technical Skills: EDC tools, SAS programming, data validation techniques
- Regulatory Knowledge: GCD, FDA 21 CFR Part 11, GDPR, HIPAA
- Analytical Skills: Statistical validation, data cleaning
- Communication Skills: Responding to queries with investigators
- Problem-Solving: Trial time-sensitive requirements and data differences
Career Opportunities After CDM
- Indian Job Titles: Clinical Data Associate, SAS Programmer, Biostatistician, Clinical Data Manager, Data Validation Specialist, Clinical Data Coordinator, Regulatory Affairs Associate
- Organizations Recruiting CDM Professionals: Biotech Firms, Pharma Firms, Research Hospitals, Government Bodies for Regulation, Contract Research Organizations (CROs)
- Indian Recruiters: IQVIA, Parexel, Syneos Health, Cognizant Life Sciences, Accenture Healthcare, Pfizer, Novartis, Dr. Reddy's
Why Clinical Data Management is Going Boom in India?
- Growing Role of India in Clinical Trials: With huge genetic diversity and millions of populations, India is a promising location to perform global clinical trials. More than 7,000 clinical trials have been registered in India until 2024, and the number is expanding.
- Benefit of Outsourcing: US and EU Pharma giants outsource CDM operations globally to India due to cost advantage and human resource. CROs such as IQVIA, Covance, Syneos, and Parexel have large big data management personnel in India.
- Digital Healthcare Transformation: With the coming of AI, machine learning, and big data technology to clinical trials, India is creating tech-enabled CDM professionals who can manage today's needs.
- Recession-Proof Career: Unlike IT or finance, healthcare and pharma development doesn't decline during crisis periods. The COVID-19 pandemic rendered careers in CDM recession-proof because it employed thousands of professionals to manage vaccine trial data.
Why BICS?
- First in Maharashtra – With B.Sc. Clinical Research with specialization in Data Management
- Global Partnerships – With Boston Clinical Trials (USA) for internship and training
- Curriculum for the Future – Blending Data Science with CDM
- Internship-Focused Model – Students have firsthand knowledge of real CRO prior to graduation
- Placement Guidance – There is a separate placement cell that links students to the best recruiters
Clinical Data Management is among the fastest-growing healthcare professions in India's pharma and healthcare sector. With increased clinical trials, regulatory affairs, and e-health solutions, there is more demand than ever for CDM professionals.
At Boston International Clinical School (BICS), we merge scholarly excellence, international affiliations, internships, and innovative application of data science to train students to be future-ready for a career in CDM professionalism. For more information contact us
12th passed student or graduate searching for specialization, BICS offers one of the finest Clinical Data Management courses in India that will lead you to an international, secure, and professional life.
