The Pharmaceutical Industry worldwide constantly endeavors to optimize the drug development process, by conducting ICH-GCP complied, cost effective, quality controlled Clinical Trials and compressing the "time to market" cycle.
In India, Apollo Hospitals Educational and Research Foundation (AHERF) is partnering Pharmaceutical Companies in their quest for excellence. This partnership with AHERF, offering its global standard expertise and infrastructure facilities, engendering in the process of a new hope for the world has been established in over nine years.
Established in the year 2000 as an independent entity, today AHERF is the FIRST and Single Largest Site Management Organization in India, coordinating and conducting ethical trials for national and international Pharmaceutical companies
Vision
To create a world respected entity for avenues in Clinical Research, covering activities from drug discovery, development, therapy and marketing to the Pharmaceutical and Biotechnology Industry.
Mission
To ensure the ethical conduct of Clinical Drug Trials (allopathic / non allopathic) according to ICH-GCP and National Guidelines at the Apollo Hospital's clinical study sites.
- To Patient - Reimbursement as per GCP
- To Physicians - Assistance in all trial related logistics, including subject screening and recruitment
- To Hospital - Meet obligations of regulatory bodies, financial monitoring and patient rights
- To Sponsor Company - Ensure timely conduct of the study and prepare for post trial audit
- Post-Graduate Educational Courses / Seminars in Clinical Research
- Develop partnerships with domestic and international organizations for collaborative research
Click here to know more about Nursing, Paramedical & Management Education Activities at AHERF...
Objectives
- To develop a research centre of excellence in the area of clinical research with good standards and values.
- To train research professionals and equip them with the critical skills needed to develop and promote scientifically valid and ethically appropriate clinical research.
- To collaborate with the Industry leaders and give hands on experience to acquire expertise in the area of clinical research.
Advantages of AHERF
- Standardized course content across all centers
- Stringent selection criteria and four rounds interview
- 6 months hands on experience in live clinical trials
- Comprehensive and wide network within the industry
- Mix of faculty from academia, industry and regulatory bodies
- 150 strong alumni with above 90% placement in industry
Career Prospects
A course in clinical research will allow the candidate to explore a whole avenue of careers. Where earlier the choices were limited to data entry and monitoring, today the choices span 13 area including clinical monitoring, clinical data management, medical writing, business development and pharmacovigilance.
The Potential Employers are:
- CROs and SMOs like Quintiles, Jubilante Clinsys, Icon, Paraxel, AHERF, SMO-India etc.
- Pharmaceutical and biotech companies like Pfizer, Johnson & Johnson, Biocon, Panacea Biotech etc.
- KPO units in companies like Wipro, Accenture, TCS etc. for data management
- Organizations like MEDWrite, GVK Biosciences etc. which offer medical writing services
- Hospitals like Medanta medicity, Max, Fortis, Indian Spinal Injuries Centre etc.
Program highlights
Hospital Tour and SMO Functionality-KYS - Know your site management organization
This program will be implemented by the training division of Apollo Hospitals Educational and Research Foundation. This is structured to ensure that students get an exposure to all the tasks, functions and responsibilities of a Site Management Organization and also the functionality of the hospitals.
The students will benefit from these practicals as they relate to the theory taught in the classroom. This program is specially designed to ensure that the students learn about the structural and functional aspects of the clinical trial activity in an organized manner. This will help the student transition in to the industry easily and reduce the need of induction training on the functional aspects.
Internship
After successful completion of the certificate course, the student will be placed full time in one of the AHERF sites for a period of 6 months. There will be a specified framework for these students to follow and take up the internship.
This will help the student appreciate the need to restructure and apply principles for decision making. They will also develop familiarity with the functional and business contexts of research. The student will be assigned to administer specific functions pertaining to conduct of a clinical trial under the guidance and supervision of the qualified personnel to fine tune their expertise.
Institute Library
The library is well equipped with a wide range of latest text books on Clinical research terminology, clinical trial activity, ICH GCP guidelines, literature on regulatory documents etc. Comfortable arrangements are made for students to enable students to read and refer books, online journals etc.
Computer and classroom facility
Students will be given access to internet and printing facility which will help them to get information from well established websites. International grade facilities for the classroom, including overhead projectors, audiovisual equipment and comfortable furniture to provide a unique and enriching learning experience.
Program Structure
The course content comprises of 16 comprehensive modules taught over a period of 6 months. These have been designed to provide students with the skills, knowledge and practical experience necessary for a successful career in clinical research. The Post Graduate Certificate Course in Clinical Research is comprised of the following segments
- Module 1 Introduction to Pharmaceutical Industry and Clinical Research
- Module 2 Drug Discovery & Development Process
- Module 3 Phases Of Drug Development Process
- Module 4 Good Clinical Practices
- Module 5 Regulations in Clinical Research
- Module 6 Research Methodology and Clinical Trials Designs
- Module 7 Clinical Trial At a Site
- Module 8 Basic Statistics and Writing a Paper
- Module 9 Clinical Trials Documents and Development
- Module 10 Clinical Trials in Children
- Module 11 Pharmacovigilance and drug interaction/reaction
- Module 12 Quality Control and Quality Management in Clinical Research
- Module 13 Clinical Data Management
- Module 14 Bioequivalence Studies and Magnitude of Bioanalytical Speciality in Clinical Research
- Module 15 Clinical Trials Finance and Budgeting
- Module 16 Medical Speciality- Problem Based Approach
Applied Theory
- Hospital visit to laboratories, cardiac department (ECG, echo, tread mill), radiology department (X-ray and ultrasound)
- Case studies
- Protocol and informed consent writing
- GCP training
- Industrial visit
- IT skill development
- Periodic communication and personality development sessions
Admission Procedure
Eligibility
Graduates with a degree in Life Sciences/ MBBS/ BAMS/ BHMS/ BDS/ BPT/ MPharm/ BPharm etc. from any recognized university and with a minimum 60% of marks are eligible.
The selection is based on the performance in an interview conducted by the panel of experts. The decision of the panel will be considered final and the selected candidate will be intimated either by email or written communication.
Intake is limited to 20 students per batch.
Course Fee Details
- Registration Fees: Rs 500 payable at the time of collecting the application forms and prospectus
- Admission Fee: Rs 50,000 payable at the time of admission
- Tuition Fee: Rs 1, 50,000 payable within three month of admission (Rs. 50,000 per month).
All payments will be accepted in form of demand drafts at our office. Fees once paid will not be refunded.
Attendance
The course design demands full attendance for the theory and practical sessions. 85% of the attendance is required and 5 % may be relaxed on medical grounds.
Examination
The students will take up weekly assignments and seminars at the end of each module. On successful completion of the final examination, the students move to internship for 6 months. The clinician/ principal investigator with whom each intern is placed will evaluate the student and provide feedback to the course coordinator. At the end of internship the students will be evaluated for the entire duration.
Pedagogy
The cardinal concern of the training course is to promote the philosophy of emphasizing self learning. We encourage an enquiring and analytical mind which proactively seeks the right knowledge, acquires skills and right attitudes suited to the environment, develop the students for better capabilities and effectiveness.
Classroom learning is meant primarily for the theoretical inputs which develop conceptual clarity, knowledge base and sensitivity to the professional environment the student will enter during his internship and subsequent career.
The exchange of ideas and opinions are encouraged in the classroom through group discussions and presentations based on the carry home exercises that we give.
The contextual and process related aspects which characterize real time clinical trial issues are illustrated and explained so that it reinforces effective management and decision making capabilities involved in a Clinical Trial Process flow at various stages.
The method of instruction utilized by the faculty is unique combination of conventional classroom teaching and B-school based interactive methods.
- Formal lectures arranged by the training division of the AHERF
- Group discussions on selected topics in the filed of clinical research
- Formal lectures by eminent people from pharmaceutical companies, academic institutions, clinical researchers
- Workshops, seminars and interactive sessions involving debates, role play and case studies
For further enquiries contact the following between 9:30 am and 5:30 pm
Hyderabad Division
Tanvi Talwar
CR Course Assistant Coordinator, AHERF Hyderabad
Apollo Hospitals Educational & Research Foundation
Apollo Health City, Jubilee Hills,
Hyderabad – 500 033, INDIA.
crcourse.hyderabad@aherf.net
+91 40 6516 9361, +91 81061 63770
Chennai Division
Dr Krishna Behara
CR Course Assistant Coordinator, AHERF Chennai
Apollo Hospitals Educational & Research Foundation
No. 16 & 17, II Floor, Krishnadeep Chambers - Apollo Annexe,
No. 1 Wallace Gardens, Chennai - 600006, India.
crcourse.chennai@aherf.net
+91 44 283 31785, +91 98417 44635
New Delhi Division
Dr Vibha Dhingra
CR Course Assistant Coordinator, AHERF New Delhi
Apollo Hospitals Educational & Research Foundation
Indrprastha Apollo Hospital
Sarita Vihar, Delhi-Mathura Road,
New Delhi -110076, India.
crcourse.delhi@aherf.net
+91 11 268 25612, +91 98182 03393
Kolkata Division
Dr Karabee Mukherjee
CR Course Chief Coordinator, Kolkata
Apollo Gleneagles Hospital, Kolkata,
58, Canal Circular Road, Kolkata - 700 054, India.
karabee.mukherjee@gmail.com
+91 33 2320 3040/2320 2122 Extn: 5621, +91 98040 00434
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