InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 22500 INR.
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clinical research course

Introduction

Features

Features

Related Courses

Course Content

About RA

clinical research

This online clinical research course focus on preclinical and clinical trial involves in drug discovery to commercialization process. The course provides orientation to practical understanding in the preclinical and clinical trial process. This course will help to learn how to manage each preclinical and clinical development stages effectively. Further, course provide extensive training on clinical trial data management which is key for the approval of the drug. Fourthly, training includes clinical trial strategic planning process. Lastly, this online training focuses on the clinical research outsourcing market. How to handle CRO effectively.

Objective of the course

The objective of this course is to impart knowledge and understanding with an opportunity to acquire and develop the expertise necessary for effective clinical research. The program is designed to meet the high demand for trained personnel for human clinical trials. The program enable you to master practical aspects of clinical trial conduct and management including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines and ethical considerations.

This clinical research training course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions. Hence this training provides real life requirement for drug development and commercialization.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

  • Course Code: RYD-036
  • Title of the course: Advance Certification in Clinical Research (ADCLR)
  • Nature of the course: Online distance learning course. So, course can be accessed online across anywhere 24×7.
  • Duration of the course: 1 Month
  • Course certification: Certificate will be provided at the end of the successful completion of the course.

  • Orientation to job related practical aspects of the clinical research coordinator. Hence, one can easily understand the practical aspects of the clinical research management job.
  • Simulation to real life working in clinical research department. It help to enhance the regulatory strategic decision making.
  • Course provides detail training on clinical data management.
  • Access to Case Studies to learn about the drug registration steps.

Who should attend this course? 

  • Those who are in working in drug discovery and development.
  • Drug Discovery R&D personnel who want advance understanding on drug approval process.
  • Professionals from drug discovery development.
  • Anyone requiring an overview of drug regulatory affairs.
  • Fresher or beginners, Those who want to make a career in drug regulatory department.

Course Content

The online drug development process course is broken down into following modules

  • The Drug Development Process Regulatory Environment. 
  • Training on Stages in the Drug Development Process – the second module provides a detailed overview of the drug development process, taking a look at the life cycle, history, timelines and phases critical to the process. The module covers the product discovery and clinical testing steps essential to the early stages of the drug development process. After that, course provides detailed understanding on the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring or reporting and patent exclusivity.

Preclinical Trial

  • Preclinical Steps in Drug Development -Training on the preclinical studies (studies in animal subjects). Topic includes preclinical pharmacology, pharmacokinetic
  • Training on GLP compliance

Clinical Trial

  • Clinical Steps in Drug Development –This covers what happens after discovering an NCE, conducting preclinical trials and completing the IND/CTA application. Attendees will learn the different phases of these clinical studies and about the NDA/MAA application.
  • Training on GCP.
  • Launching and marketing of Innovative Branded Drug – marketing planning, strategic initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and backward integration for the branded pharmaceuticals for managing high ROI.
  • Strategies of Clinical Trials.
  • Clinical Publications handling.
  • CRO market.

Bioequivalence Study

  • PKPD trial
  • BABE study

Real World Data and Real World Evidence 

Career in Clinical Research

Clinical research is a field that deals with the study & analysis of health & illness in Humans. It is the means through which scientists analyze how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigation. It involves human participants and helps translate basic research into new treatments and information to beneficial for patients.

Clinical Trials or Clinical Studies involves human volunteers. These type of research or experimental studies enables various groups of researchers and investigators to search for new and more effective ways to understand, discover, regulate as well as deal with different types of human disorders/ diseases/ abnormalities. In other words, we can say that these trials are the best way to get answers to any difficult scientific / health-related queries.

Goals of Clinical Research

All clinical trials should meet certain goals to fulfill their design or use of conduct. It must :

  • Enhance therapeutic understanding
  • Be implemented by adroit persons,
  • Take all important steps/actions to protect those who accommodate themselves to research,
  • Acquire regulatory acceptance and take all the obligatory legal and ethical steps.
  • Gather the assent of those involved in research

Role and Responsibility of Clinical Research Associate

A clinical research associate (CRA) plays an important role managing this process and organizing all the information. This career would be an excellent choice for someone looking for a documentation job with a difference.

The Role of CRA

The role of a clinical research associate in simple terms is to coordinate the collection, distribution and storage of data obtained during clinical trials. The execution of this role, however, involves quite a few responsibilities.

  • Develop and write clinical trial protocols
  • Develop forms and templates for data collection
  • Coordinate with Ethics committee
  • Set up trial sites, ensure trials are conducted as per procedures and regulations
  • Educate patients, doctors and other personnel about the trial
  • Monitor the conduct of trials at various sites and review data for regulatory submissions
  • Prepare reports, presentations and manuscripts for publications

The responsibilities of a CRA are not limited to one department, location or site. Being a CRA involves working with a large number of different people and in different setups.

CRAs can find employment within Clinical Research Organizations (CRO), pharmaceutical and biotechnology companies and occasionally in hospitals.

Clinical Research Organization (CRO)

A Contract Research Organisation, also called Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).

Section 1Drug Discovery Development Process
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) Filing 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Handling of orange book
Lecture 9Purple Book: Significance | Searching | Assignments
Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 11Authorized Generics: Key Understanding
Lecture 12Exploratory IND Vs. Traditional IND
Lecture 13Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 14Orphan Drug Designation 
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16USFDA expedited programs
Lecture 17EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 18EMA and EMA Authorisation Process
Lecture 19EU MA Application Types and Strategic Planning
Lecture 20EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 21EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 22IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 23Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Section 2Preclinical Trial - Nonclinical Study
Lecture 24Preclinical Trial
Lecture 25Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 26Types and Timing of Non-clinical Studies 
Lecture 27
Lecture 28Good Laboratory Practices
Section 3Clinical Research
Lecture 29Understanding on Clinical Trials  and Clinical Research 
Lecture 30Clinical Trial Protocol Writing
Lecture 31Ethics in Clinical Research
Lecture 32Informed Consent
Lecture 33Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 34Advance Training on GCP
Section 4PKPD | BABE Study
Lecture 35PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 36Bioequivalence Study | Study design | Different types of BE Studies
Lecture 37Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 38Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 39Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 40Bioequivalence Study - Discussion - Dissolution Testing
Lecture 41Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 42IVIVC - Importance | Significance | Case Study on IVIVC level
Section 5Real World Data (RWD) | Real World Evidence (RWE)
Lecture 43Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 44RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 45RWD and RWE in Product Lifecycle Management
Lecture 46WD and RWE - Fit to use | Assessment
Lecture 47RWD data sources | Different types | Detailed understanding of each class