* Diploma in Clinical Research & Clinical Data Management * Diploma in Clinical Data Management * Diploma in Pharmacovigilance & Clinical Data Management * Certificate Course in Pharma Regulatory Affairs

Diploma in Clinical Research
and Clinical Data Management

Duration : 6 months (Weekend Batches)

The programme involves 5 Modules.

Eligibility
MBBS, BAMS, BDS, BHMS, BPTH & BOTh, B.Pharm / M. Pharm, Graduates / Post Graduates in life Sciences with any of the following subjects  - Chemistry, Zoology, Biochemistry, Microbiology, Genetics & Biotechnology.

Certificate Course in Pharma
Regulatory Affairs

Duration: 2 months

• Pharma Regulatory practices & procedure
• Pharma patents, IPR & regulation
• Pharma Regulatory Regime in VSA, EV & INDIA.
• Clinical Trials & Regulation
• GMP QA, Regulation
• Regulatory compliance for pharma & BT products

Course Features :
1. Weekend Batches
2. Highly experienced & eminent faculties
3. Comprehensive course material
4. Library facility

The Clinical Research Industry
 The Clinical Research industry worldwide is growing at an exponential rate. It has opened windows of employment for a large number of trained professionals. In India, Clinical Research industry is fast expanding. This is primarily due to the availability of a large and diversified diseased patients-pool. Also the excellent infra structural facilities, cost effectiveness compared to the west coupled with perfect regulatory system have made India one of the Clinical Research hubs in the world.
  With India offering 10 year tax concessions on revenue to local companies making Research & Development (R&D) investments,  a substantial increase in R&D activities of both multinational and domestic biopharmaceutical companies is inevitable. Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually. Many pharmaceutical and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India. Thus, there is a huge demand for qualified and trained Clinical Research professionals.
  Considering large demand for Clinical Research professional in India alone science, Life Sciences, pharmacy and Medicine Graduates may look forward to exciting and rewarding career opportunities in clinical research.

Clinical Research Career Opportunities

Based on different kind of knowledge
and skills

Following positions can be sought as a
Clinical Research Career:

• Product Physician
• Protocol Writer
• Case Report form (CRF) Designer
• Medical Writer
• Medical Translator
• Trial Monitor
• Medical Communicator
• Trial Pharmacist
• Ethics Committee Member
• Regulatory Manager

Diploma in Clinical Data Management
(6 months) Weekend Batches

Course Modules

• Introduction to Clinical Data Management
• Overview of Drug Discovery & Clinical Research,
• Overview of Clinical Data Management
• Overview of guidelines for ethical practice and accepted international regulations
• CRF Designing , Database Designing and Validation, Data Entry Processes
• Discrepancy Management & Query Writing
• Serious Adverse Event Reconciliation
• Laboratory Data Handling
• Database Closure

Project: Practicals and internship

Application System Review
Designing a study
Data Entry
Discrepancy Management
Lab Systems
Lock Et Freeze

Career Oppurtunities

As globalization occurs within the field, there will be continuing industry demand for people with  strong skills in handling large data generated by clinical trials. The students of the program will have an understanding of the processes involved in biotechnology, medical device and pharmaceutical industry. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in Clinical Research and Clinical Data Management would get a thorough understanding of current applications to the development and commercialization of drug, biologic and biodevice products. The Clinical Data Management program provides professionals with the specialized knowledge required to help biotechnology, medical device and pharmaceutical companies to manage their data and generate job opportunities in data management.

Job Opportunities Data Entry Specialists Clinical Database programmers Medical Coders Medical Reviewers Trial Designers Clinical Data Managers Biostatisticians