Bioinformatics Centre, University of Pune
'‘Postgraduate Certificate Course in Clinical Research and Clinical Data Management' (CRCDM) 6 months (weekend course)
            

Genesis of the course (Workshops)

Series of workshops had been designed by Bioinformatics center, University of Pune, together with Synergy Network (I) pvt ltd. renowned experts form industry and academics were invited for workshop and curriculum development meeting. Dr R. A. Mashelkar (DG CSIR), Dr. N. K. Ganguly (DG ICMR), Dr. Vasantha Muthuswamy (SDDG ICMR) and Dr M. K. Bhan (DBT) have appreciated the past three workshops on Clinical Research and Clinical Data Management and the syllabus for certificate courses developed by University of Pune, Bioinformatics center. 

• The list of workshops conducted
• List of Speakers at the International Workshop

Eligibility

Any one of the following minimum qualifications is required (mandatory) to be eligible:

Eligibility: Minimum qualifications required to be eligible: MBBS / B.D.S / B.A.M.S / B.H.M.S / B.E. / B. Tech/ B. Pharmacy / BVSC/ B.Sc. (Nursing)/ MCA/ MBA/ M.Sc. / M.Pharm/ MA (Maths or Statistics)/ B.Sc. (with minimum one year relevant industry/ academic research work experience. But preferences will be given to the Postgraduate degree holders.)

Reservation: As per Government of Maharashtra rules, 50% seats are reserved for SC, ST, DTNT, OBC and 3% seats are reserved for physically handicapped students.

Preference will be given to those who have work experience in a medical institution, pharmaceutical company, or Clinical/Research unit. Students applying for the course should note the eligibility criteria, as they will be responsible if they do not fulfill the eligibility criteria. Postgraduate degree as given above is required to be eligible for the course. Please note that graduates from medical, pharmacy, engineering, veterinary and nursing professions and B.Sc. with minimum one-year relevant industry experience are eligible. But preferences will be given to the Postgraduate degree holders.

Eligible students list will be announced online and they will be registered only on receipt of completed registration form accompanied by the required bank draft Admissions will be done on the basis of merit in educational qualification and experience in the field of medical sciences, life sciences, data management, & clinical research. Candidates not selected for current course will be given preference for the next semester course.

Career Prospects

Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization). Jobs are also available in pharmaceutical industry, drug development, medical writing, and biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials.

The CRCDM 6 month weekend course is useful for: 

• Doctors – Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician.  
• Pharmacists, Life Science graduates, Science postgraduates in Biochemistry- Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and Drug Development Associate, Biostatistician, Quality assurance 
• Management Graduates (MBA) – Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
• IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics – Clinical Data Manager, Drug Development Associate.

Placement:

Past students are working at Accenture, ICON, GSK, PRA International, TCS, i3 Research, i3 Statprobe, Bilcare, Hindustan Unilever, Serum Institute, Macloeds, Emcure, Reliance Clinical Research Services, Jaslok Hospital, Sanofi Aventis, Fortis, Apollo Neemans Hospital, Jehangir Hospital, Dinanath Mangeshkar Hospidtal, Ruby Hospital, Panacea Biotech, iGate, GVK bio, CliniRx, Lundbeck, Jubilant Clinsys, Novartis, Lilly, Ranbaxy, Fortis, Persistent, Neemans, Pfizer etc

Bioinnovat Research Services will provide assistance to the students in finding suitable placement

Learning outcomes

After completion of course the Participants should be able to:

• Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management. 
• Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, in bio-IT life science industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting trials on subjects. 
• Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring. 
• Participate in design, conduct and management of global clinical trials conducted at multicentric sites in India and Overseas.
• Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc

• Post Graduate Certificate course in Clinical Research and Clinical Data Management will be covered in two modules within six months beginning with a foundation in clinical research and followed by data management. Medium of instruction will be English. The course is designed for postgraduates and those working in industry or hospital / clinical sites and is scheduled on weekends i.e. Saturday and Sunday only.

  Please Note:

  ·         The course does not include any direct trials / experimentation on human or animal subjects. 

  ·         The practical work will be done by students as assignments during the weekdays at their workplaces. Limited number of computer access will be available at the learning centers. 

  ·         The students in addition should have their own personal access to Internet for assignments, projects and communication. 

  Teaching Methodology:

  ·         Theory lectures will be conducted over week ends at the venue by faculty approved by Bioinformatics Centre, University of Pune. Course material will be provided on Compact Discs and through an e-learning system introduced in 2007. 

  ·         The practical will be done by students in form of assignments during the weekdays, as per their convenience, for which they are expected to have independent access to internet. 

  ·         Projects: Each student will select the topic for his project within eight weeks of joining the course. Thus the projects can be taken by a group of students (not more than 5). Students will send their proposal to Bioinnovat Research Services who will help to nominate the guides. The project should involve about 10 days of research work. 

  ·         Note: This being a post graduate certificate course the students are expected to gain knowledge through interaction with the faculty, use of library /internet and self-study of course material.

Faculty

Faculty for the previous course included the following 
· Prof. Dr. A.S. Kolaskar. Ex VC ,Pune and Advisor Knowledge Commission.
· Prof. Dr. Indira Ghosh, Dean, School of Information Technology, JNU. 
· Dr. C.L. Kaul. Advisor, CRCDM Bioinformatics Centre, University of Pune, Former Director of NIPER.
· Ms. Sharvari Shukla. Faculty, Biostatistcian, Bioinformatics Centre, University of Pune.
· Ms.Guljit Chaudhri. Advisor, i3 Research.
· Dr. Vidyagauri Baliga. Senior Manager, Medical Information Services, Glenmark Pharmaceuticals Ltd.
· Dr. Sudhakar Bangera. Vice President - Site Management Services, Manipal AcuNova Ltd. Bangalore.
· Dr. Prashant Bodhe. Sr VP Clinisearch Biotechnologies, Mumbai
· Dr. Krathish Bopanna. Chief Technology Officer, Manipal Acunova, Bangalore.
· Dr. Murtuza S. Bughediwala. Head, Clinical Operations & Business Development in ClinInvent, India.
· Dr. Arani Chaterjee. General Manager-Clinical Research,Panacea Biotec.
· Dr. Aneesh Desai, Vice-President (Medical & Clinical Development), Glenmark Pharmaceuticals Limited
· Murali Ganesan, Head Data Management & Head Biostatistics, Reliance Clinical Research Services, Mumbai.
· Dr. Jayanti Gupta, Strategic Consultant for Biostatistics-Clinical Data Management, Mumbai.
· Mr S. Ramu, Executive Director, Quintiles Technologies.
· Mr.S. Rangwala, Director Clinical Operations & Data Management, GVK Bio.
· Dr.A.Muzumdar, Clinical Research Physician lilly,ex GVK Bio.
· Mr. B.Burnstead, Director,I3 Statprobe,UK.
· Dr.F. Greer, Director, MScan, USA.
· Dr.Bhupesh Deewan, Scientific advisor Emcurepharmaceuticals Ltd.
· Dr. M A Tutakne, ex VC, Symbiosis International University.
· Dr.V.W. Tilak, Former dear AFMC and Dr. D.Y.Patil Medical college, Pune.
· Dr. Rajesh Jain, Project Manager, Reliance.
· Dr. R. Kuchibhatla, Director, Clinical Research & Development, Biostatistics and Data Management, Targacept, Inc
· Dr. Mukesh Kumar, wockhardt 
· Mr. S.Londhe, Bioinformatics Centre, University of Pune
· Dr.Raj Madapalli, Reliance Clinical Research Services, Mumbai
· Dr. Yashesh Mehta, Head, Quality Assurance and Training,Reliance Clinical Research Services Pvt. Ltd
· Dr. Vasantha Muthuswamy, Sr. Deputy Director General, Indian Council of Medical Research, New Delhi
· Dr. Ramananda Nadig,Chief Operating Officer, Stemputics Research Pvt.Ltd, Bangalore
· Dr. Puneet Kumar Nigam, Chief Technology Officer, Dr. Lals path lab 
· Mr.Sanjay Patel, Associate Director and Head - data Validation, Quintiles Technologies 
· Durga Phalke, Sr Executive QA, Reliance Clinical Research Services, Mumbai
· Dr G. Pujari, Manager, Clinical Research, Reliance Life Sciences Pvt. Ltd. 
· P Subbarayan, Head Quality, Neeman Asia. Mumbai 
· Ms. Susan Trainer, Trainer & Partners, Belgium
· Dr Anupama Rajkumar, Medical Director, Lambda Therapeutic Research, Ahmedabad
· Dr.S. Mehta, Director,Vaccines, Path
· Dr. Shona Nag, Prinicipal Invertigator, Jehangir Hospital
· Mr. D Babre, Associate Director,Pharmanet, Mr. K. Parvez, Clinrix
· Dr. V. Ranade, Prinicipal Inverstigator, Dinanath Mangeshkar Hospital 

Eligibility: Minimum qualifications required to be eligible: MBBS / B.D.S / B.A.M.S / B.H.M.S / B.E. / B. Tech/ B. Pharmacy / BVSC/ B.Sc. (Nursing)/ MCA/ MBA/ M.Sc. / M.Pharm/ MA (Maths or Statistics)/ B.Sc. (with minimum one year relevant industry/ academic research work experience. But preferences will be given to the Postgraduate degree holders.)

Reservation: As per Government of Maharashtra rules, 50% seats are reserved for SC, ST, DTNT, OBC and 3% seats are reserved for physically handicapped students.