Single Program Covers all Modules: Clinical Research, Clinical Data Management, Pharmacovigilance and Medical Writing
Starting soonCourse Brief
- This program is oriented towards candidates interested in joining the clinical research industry, in Clinical Trials, Clinical Data Management, Pharmacovigilance or Medical Writing domain.
Methodology:
The course will be taught via lectures, discussions, group assignments, case studies, workshops and site visits conducted by prominent industry professionals.
Faculty
Faculty at CLINI INDIA includes Senior Professionals with 5-10 years of Clinical Research industry experience, who currently working in senior positions in multinational pharmaceuticals or contract research organizations.
Attendance
The course design demands full attendance during all the sessions. 85% of the attendance is required and 5 % may be relaxed on medical grounds. In case students miss few classes they can be be supported by backup sessions.
Eligibility
- MBBS/ BDS/ BAMS/ BHMS etc-Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
- Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
- M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, botany, zoology), basic science (chemistry), nursing, physiotherapy, occupational therapy, social sciences with work experience in clinical research.
- Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
- Experience of working in the health/ pharmaceutical sector.
- Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.
Admissions
The admissions department follows a well defined and detailed admission process. This process judges candidates on a number of parameters.
CLINI INDIA has found over the years that students who perform well in the academic programme are typically those who have a consistently good academic record during their school, high school and graduation level, besides exhibiting sufficiently performance during Telephonic or Face to face counseling. Therefore CLINI INDIA uses multiple parameters, namely academic performance in school, high school and graduation programmes as well as a good written and oral communication is required..
Examination
The students will take up monthly tests and seminars at the end of each module. On successful completion of the final examination. Our faculties will evaluate the student on the technical and vertical skills, and provide feedback to the course coordinator, followed by training participation certification.
Month 1:
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CLINICAL TRIAL OPERATIONS
DetailsTime to complete: 2 hours
Video Preview
A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering Or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.The course will explain the basic principles for design of clinical trials and how they should be reported. Participants will be introduced to terminology used in clinical trials and the several common designs used for clinical trials. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.
Month 2:
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CLINICAL DATA MANAGEMENT:
DetailsTiming: 2 hrs DailyA Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering Or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug. Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.
Video Preview
A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering Or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.
Month 3:
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PHARMACOVIGILANCE
DetailsTime to complete: 2 hours
Video Preview
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.In general, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines preventing harm to patients.Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally uses for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.”
Month 4:
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MEDICAL WRITING/ ReGULATORY AFFAIRS
DetailsTime to complete: 2 hours
Video Preview
Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information.The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.
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