Clinical Research

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

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.

Few of the similar courses

• US Pharmaceutical and Biopharmaceutical Regulatory Affairs
• Drug Registration and Regulation in China
• Drug Discovery and Development to Commercialization
• European Drug Regulatory Affairs
• Drug Registration and Regulation in GCC countries
• UAE Drug Regulation and Registration
• Drug Biologic Medical Devices Regulatory Affairs
• International Drug Regulatory Affairs

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, GLP compliance and more.
• Training on GLP

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

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).