About This Course
Focused training in clinical research fundamentals and medical writing, covering regulatory documents, scientific publications, and ethical writing practices.COURSE HIGHLIGHTS 100% Placement Assurance. Outstanding Placement Track Record. Over 3000 students have been suc and pharma industries. Globally Validated Curriculum. Only Institute with In-house CRO facility. Classroom/ Practical training by...
Show moreWhat you'll learn
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Clinical research basics & documentation needs
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Regulatory writing (protocols, CSRs, IBs)
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Scientific writing (journals, abstracts, case reports)
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Publication ethics & ICH/GCP guidelines
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Practical writing workshops
Course Curriculum
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Week 1 – Basics of Clinical Research
readClinical research framework & ethics Role of medical writing in trials
Week 2 – Fundamentals of Medical Writing
readTypes of documents: regulatory, scientific, marketing Writing clinical trial protocols
Week 3 – Regulatory & Scientific Writing
readInvestigator brochures, clinical study reports (CSR) Writing manuscripts for journals
Week 4 – Publication Ethics & Guidelines
readICH/GCP & CONSORT guidelines Avoiding plagiarism in writing
Week 5 – Practical Writing Workshop
readDrafting abstracts, case reports, and SOPs Peer review of documents
Week 6 – Mini Project & Review
readPrepare a regulatory submission document Final assessment + career prep
Prerequisites
M.B.B.S / B.D.S / B.A.M.S / B.H.M.S.
B. Pharmacy / M.Pharmacy / B.M.L.T
BSc in M.L.T / B.P.T / BSc in Nursing.
BSc and MSc in Biotechnology, Microbiology, Genetics
B.E (Biotechnology) / B.tech (Biotechnology).
Biochemistry ,Botany , Zoology ,Statistics or life sciences.