Offers Skilled Nanodegree in Clinical Trials, Pharmacovigilance and Regulatory Affairs (CTPRA)

Before new drugs, biologics or medical devices reach the market, it enters a clinical research trial to investigate whether the new treatment or device is safe and effective for humans. As more funds are funneled into the development of new drugs, the need for qualified clinical researchers to conduct and administer these projects will continue to grow. With this Skilled Nanodegree, you will master practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process Pharmacovigilance training, FDA regulations and ICH guidelines, data management and analysis, operations, global studies, quality control and assurance, compliance and bioethics.

Any research that impacts the care and well-being of human population come under the domain of clinical research. Clinical research in a broader sense involves epidemiologic studies, clinical trials, translational research, patient-oriented research, behavioral science and, health service research. High quality data and reliable results are key to generate evidence for decision making and to provide impetus for improving patient care. To produce such data, a systematic and multidisciplinary approach is required involving a range of disciplines like basic sciences, biotechnology, pharmacology, clinical medicine, statistics, and public health and behavioral sciences. This programme will broaden students horizon of knowledge on the subjects including clinical trials epidemiologic studies translational research behavioral science patient-oriented research and health service research.

In addition the programme will also enable students to analyze high-quality data and to develop reliable results for the key generation of evidence facilitating impetus for improving patient care. The programme helps students in gaining expertise in research and development processes to develop new applications to upgrade medical science. The accurate balance of theoretical and practical sessions enable students to apply best of their knowledge and produce concrete results with learning.

Program Contents

The multi-disciplinary curriculum will be covered under the core & elective courses (modules). The core modules include: Basic Epidemiology, Basic Bio-statistics, Clinical Trials-Design and Analysis, Conduct and Operational Issues in Clinical Trials, Bioethics and Regulatory Affairs, Systematic Reviews, Proposal Development and Medical Writing, Data Management, Drug Development, Pharmacovigilance and Project Management. Under elective courses we offer various areas that will fall under Research Methods, Statistics and Laboratory Sciences.

Following are the core competencies acquired by the candidates at the end of the NanoDegree’s program:

  • Reviewing existing evidence in literature
  • Developing a grant application in bio‐medical research
  • Managing ethics and regulatory approvals of protocols
  • Managing a research project
  • Managing research data
  • Planning and executing statistical analysis
  • Communicating research results to a scientific community

Programme Features

  • Strong student-teacher rapport, inquiry-based learning conducive to breed excellence
  • Meticulous grooming, in sync with your inclination, temperament and proficiency, gives you a competitive edge
  • 100% placements assistance in top Healthcare & Clinical Industries

Selection Process

All candidates should submit the application form for the NanoDegree program in the prescribed format, which can be downloaded from website. The application consists of registration form, proof of academic credentials, work experience, contact details of 2 referees (academic and/ or professional) and a statement of purpose. The applications will be short-listed based on their academic qualifications, relevant experience and statement of purpose. This will be followed by an interview. The selection of candidates will be executed by a specially constituted screening committee.

Program Structure

The NanoDegree in Clinical Research is an intensive one semester program focusing on the scientific, ethical and operational issues related to clinical research.

Program Fees

The fee structure for NanoDegree program for the candidates admitted in the year will be as follows:

For Indian and South Asian Nationals

Tuition Fee: The complete tuition fee for the students admitted in academic year is INR 65,500/- per student .

For International Candidates

Tuition Fee: The complete tuition fee for the students admitted in academic year is USD 1150 per student .

Career path you can choose after the course

  • For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
  • For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trail analyst / Drug Reviewer / Drug Safety Physician & many more
  • For Management Professionals: (with Life Science/Health Science background) Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
  • Clinical Research Associates: To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
  • Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
  • Study Coordinators: Provides safety & protection while collecting & managing the study data.
  • Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
  • Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
  • Clinical Trials Auditors: Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
  • Clinical Research Managers: Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
  • Business Development Manager: Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
  • Drug Safety Associate: Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
  • Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.
  • Others: Auditors, Quality Assurance, Patents & IP Related position

Eligibility Criteria

  • Graduate/Post Graduate degree in Pharmacy/ Pharmaceutical Science
  • Graduate/Post Graduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology)
  • Graduate or Equivalent degree in Nursing/Allied Health
  • Students in their Final Year of Graduation for the above courses may also apply.

Program Highlights:

  • Study Material
  • Assignments/ Projects
  • Final Exam
  • Placement Support Program

A NanoDegree with Distinction will be awarded to those who complete the NanoDegree with a GPA of 6.0 or higher. The NanoDegree can be completed within One semester (Six Months).

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