Clinical Research and Clinical Data Management course

Hi,

This is the brief outline of the forthcoming Clinical Research and Clinical Data Management course in Orissa. Please circulate this info and let me know how many students you can refer for this course to be conducted for the first time in Orissa.

As discussed, I would like to have a Coordinator stationed in Bhubaneswar with the following requirements - Good Spoken English skills, Networking ability, Science background. Will be placed ASAP following interview. Nature of work: to take calls from prospective students and follow up with them for admission, Coordinate with various colleges in Orissa to get more visibility and get more candidates for subsequent courses, coordinate with renowned speakers and arrange for their visit to Bhubaneswar

In case this person wants to take the course too, he/she is eligible and can enroll too (the fees may be waived/reduced for this option).

Kindly respond ASAP with CV of suitable candidates for the above post.

Thanks & Regards

Sauren (Moonoo)

'Clinical Research and Clinical Data Management' (CRCDM)
Post Graduate Certification
6months (weekend course)

Introduction

New Pharmaceutical Drugs, biological, herbal and natural remedies, nutraceuticals and probiotic food products, and select cosmetics require drug safety and efficacy testing before they are introduced in the market. This testing for drugs on humans comprises Clinical Trials referred as Phase I, II, III trials prior to market launch of the product & Phase IV after market introduction. The data collected from these trials has to be submitted to the respective health authorities of the countries to seek marketing approval for introduction of the product.

The Drug Controller of India in 2003 introduced GOOD CLINICAL RESEARCH PRACTICES wherein it is mandatory that all the clinical trials conducted in India follow these practices in design, approval collection of subject data. Complete compliance of GCP guidelines in India is required for conduct of clinical trials.

India has one of the largest patient populations for most of the diseases with genetic diversity. Availability of highly qualified medical practitioners is attracting conduct of global clinical trials in Indian hospitals and clinical sites since India has implemented GCP as per ICH global standards. It is now possible that the data from conduct of trials in India as per GCP guidelines maybe submitted for approval of the drug in USA, Europe, Japan, etc along with submission to authorities in India. The clinical trial industry is doubling in revenue every 2years and as per Mckinsey estimate India has the potential to become one billion dollar revenue industry.

This high growth has created the mandatory need for more clinical research professionals in GCP for conduct Management of the trials.

Eight batches of this course have been successfully completed by December 2008 and most of the students are now working in pharmaceutical, biopharmaceuticals Clinical Research organizations.

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.

Eligibility

Any one of the following minimum qualifications is required (mandatory) 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 )

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, 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 Math, Applied Math, operational Research, Statistics – Clinical Data Manager, Drug Development Associate.

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 .
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• 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.
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• 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

Course Duration

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.

Fee Structure

The fee structure is as follows:



Total Course Fees payable in 2/3 installments:

1. Rs. 25,000 with application (Mandatory)
2. Rs. 25,000 with in 4 weeks after start of course
3. Rs. 20,000 within 12 weeks after start of course

Note: Registration fees will be refunded after deducting Rs. 500/- only if cancellation is made in writing / by email to Bioinnovat within one week.
No refund will be done after that of starting of the course.


--
Sauren
Dr.Saurendra Das
Country Head and Director of Operations
Excel Life Sciences Pvt Ltd
B -155, Sector 63
Noida - 201301
U.P
91 99710 99950
sauren@excellifesciences.com