Biocon KGI Certificate Program in Clinical Development

Biocon Academy has partnered with Keck Graduate Institute in Claremont, California, for this one-of-its-kind certificate program in Clinical Development.

Biocon KGI Certificate Program in Clinical Development is a 16-week full-time program aimed to empower pharmacist with application know-how of the design, implementation and statistical knowledge. This application know how is provided to them through experienced faculties of Keck graduate Institute. The specific focus of the program is to train pharmacy candidate in the areas of clinical trial design, execution, clinical data management, statistical analysis, interpretation, and presentation.

Key Differentiators

Hands on experience with real patient data at Narayana Hrudalaya
Students will gain US credit points 12 making it easier to pursue higher studies in US
An edge for B Pharm students to get in Pharmacy practice after this course instead of 3 years Baccalaureate Program to qualify
Job skills-based curriculum covering CRA, CDM
Kickstart your career with Biocon and Syngene in meaningful roles with this unique program

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Key Modules

Clinical Biostatistics

This course provides a basic primer in statistical methods commonly used in the design of clinical trials. Topics covered are expected to include data reporting and descriptive statistics, probability, estimation, hypothesis testing (parametric, non-parametric, and categorical), multi-sample inference, regression and correlation. Sample size and power estimation methods will be developed for various hypothesis testing scenarios.

Clinical Trial Conduct, Audit and Compliance

This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products. Clinical trial design elements will be examined in the context of their impact on clinical trial outcomes. Emphasis will be placed on trial design and conduct that reflect the biological nature and mechanism of action of the therapeutic product being tested, rather than a cookbook approach. Discussions will include operational issues impacting execution of clinical trials and why they are critical elements of successful clinical development programs. Students will gain an understanding of the principals and FDA requirements for conduct of a human clinical trial including: required documentation, clinical trial practice, participant’s rights and approvals required pre- and post-approval. There will be an emphasis on clinical trial design, development and conduct as students work on team projects to develop their own mock-clinical trial documentation and solutions in the context of clinical trial strategy, conduct and timelines.

Clinical Trial Design

The course will provide in-depth information about conducting randomization, planning sample size, analyzing clinical trials (including phase I, II, III, and IV designs), and reporting and interpreting results of studies. Epidemiologic principles necessary for designing clinical research studies will be reviewed. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, and bio-statistical analysis issues will be discussed. Students will read and critically evaluate current research in the medical literature to enable critical use of published information in the evidenced-based practice of pharmacy. Students will develop a clinical trial research study protocol.

Toxicology & PK/PD

Principles of pharmacokinetics. Concepts of drug disposition: Absorption; Distribution; Metabolism; Excretion ADME). Application of pharmacokinetic principles to the calculation of drug doses. Chemical aspects of drug metabolism. Drug toxicology concepts: carcinogenesis, mutagenesis, keratogenesis and organ/systemic toxicity. Analysis of drugs in biological fluids and clinical pharmacokinetic applications. Concept and clinical role of pharmacogenetics. Pharmacodynamics. Concept and application of therapeutic drug monitoring (TDM). Pharmacokinetic considerations for adverse effects and drug interactions. Clinical pharmacokinetics of selected drugs, including aminoglycosides, digoxin and anticonvulsants.

Data Management Systems for Clinical Trials

This course is designed to design data capture methods, and to organize and manage clinical trial data collected from one or more sites. Topics include data flow from site to sponsor, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database procedures; patient confidentiality; and ICH Guidelines, cGMP 21 CFR part 11 compliance.

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Eligibility Criteria

Education Qualification

B.Pharm
M.Pharm
Pharm.D
MSc Life sciences (including MSc Biology/ Biochemistry/ Biotechnology/ Microbiology etc.)
B.Tech
M.Tech

Minimum CGPA/Percentage Required

CGPA: 6.8 or above on a scale on 10
Percentage: 65%

Adherence to the eligibility criteria is mandatory. Kindly note the same and apply only if you fit the desired eligibility criteria as mentioned above.

Program Fee & Scholarship

The Biocon Merit Scholarship of 60%-75% of the program cost offered to all selected students will enable them to pursue this one-of-its-kind program at an affordable cost.

Student Share: INR 1,50,000 + 18% GST

Student Facilities

At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.

Industry Placements

At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.

Transport

We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.

Meals

Throughout the course, Biocon Academy students are provided with nutritious and sumptuous lunch at the Biocon Academy premises. They also have access to beverage vending machines for tea, coffee, and milk throughout the day.

Accommodation

Students come to pursue studies at Biocon Academy from different parts of the country and upon their request, we provide options of nearby paying guests and hostel accommodations based on the previous student choices. Kindly note that students and their parents/guardians alone are responsible for any decision taken regarding their stay.

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Biocon KGI Certificate Program in Clinical Development