Biocon KGI Certificate Program in Clinical Development

Biocon Academy, a one-of-its-kind Centre of Excellence for Advanced Learning in Applied Bio-Sciences, announces the commencement of 'Biocon KGI Certificate Program in Clinical Development” - in collaboration with Keck Graduate Institute in Claremont, California.

Biocon KGI Certificate Program in Clinical Development is a 16 weeks 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 Differentiator:

  • Hands on experience with real patient data at Narayaba 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

Kick start your career with Biocon and Syngene in meaningful roles with this unique programs.
 

Course Structure

Biocon – KGI Certificate Program in Clinical Development
Module 1 Module 2 Credits Duration
ALS 437: Clinical Biostatistics ALS 433: Clinical Trial Conduct, Audit and Compliance 1.5 each 8 weeks each
ALS 438: Clinical Trial Design 3 16 weeks
ALS 440: Toxicology & PK/PD 3 16 weeks
ALS 441: Data Management Systems for Clinical Trials 3 16 weeks
5 Courses 12 Credits 16 weeks

Course Modules

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.

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.

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.

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.

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.