Professional Certification in Clinical Research and Management Course
The Professional Certification in Clinical Research and Management (PCCRM) course equips students with a clear understanding of the fundamentals of clinical research and all the important processes involved in the clinical research industry. It also provides professional training for a successful career in clinical research.
The course is structured so students will easily understand the concepts and know how to effectively apply this knowledge in real-world industry settings. PCCRM is the only single course which allows you, the student to pursue ANY of the various opportunities within clinical research.
The PCCRM course is designed to meet industry demands and moulds both freshers and experienced candidates to become exceptional professionals in the clinical research arena. The course also focuses on developing and enhancing your “invisible resources” (oral & written communication abilities, decision-making, leadership qualities & time-management skills) to give you a clear advantage over other candidates in the fiercely competitive job market.
Professional Certification in Clinical Research and Management Curriculum
The PCCRM curriculum is divided into five (5) modules in online learning mode. Each module is further divided into chapters
Module I: Fundamentals of Clinical Research This module will help you master the core fundamentals of clinical research starting with the background and history of clinical research. Then, you will learn the relevance of the fields of pathophysiology and pharmacology in clinical research. Later, you will focus on the process of drug development and its mechanisms before learning the different trial phases. Finally you will learn the distinction between Intellectual Property Rights and Patents that form the DNA of clinical research and you will learn their importance. Contents of Module I
- The Pharmaceutical Industry and Clinical Research: An Overview
- Introduction to Clinical Research
- Clinical Research Terminologies
- CRO’s and Clinical Research Careers
- Patho-physiology, Pharmacology-Relevance to Clinical Research
- Introduction to Drug Development
- New Drug Discovery
- Drug Formulation
- Pre-clinical Drug Development
- Approval Processes (IND, NDA, ANDA)
- Clinical Trial Design
- Bio-pharmaceutics, Bioavailability
- Clinical Development of Drug
- Intellectual Property Rights (IPR) and Patents
Module II: Guidelines in Clinical Research This Module focuses on the ethical guidelines detailed in the Good Clinical Practice (GCP), Declaration of Helsinki, Belmont Report, Nuremburg Code, etc that form the base of the clinical research pyramid. A good understanding of the principles of GCP is mandatory for handling clinical trials. Further, you will learn the regulations governing clinical research and particularly gain inputs on DCGI, Schedule Y which set the regulations regulating clinical trials in India. Contents of Module II
- Ethics in Clinical Research
- World Medical Association Declaration of Helsinki
- Ethics Committee-IRB/IEC
- Brainstorming ICH-GCP
- Clinical Research Regulation in India – Drugs Controller General of India (DCGI)
- Schedule Y
- Regulatory Bodies in USA, Europe and Australia
- Special Concerns
- Investigator Brochure
- Informed Consent Process
- Record Keeping and Data Handling
- HIPAA in Clinical Research
Module III: Clinical Research Verticals This module will give you an in-depth view of the different verticals in clinical research, ranging from Clinical Research Coordinator (CRC) to a Medical writer and Biostatistician etc. Clinical trials are conducted in an increasingly complex and regulated environment. Hence, a robust understanding of the roles and responsibilities of different verticals in clinical research industry would give you an advantage of handling similar trials/situation in any complex setting. As a clinical research professional, you must be able to work effectively with investigator, sponsor and clinical research co-coordinators to accomplish key objectives of the trials. Contents of Module III
- Sponsor and CRO
- Site Selection and Recruitment of Subjects
- Clinical Research Coordinator
- Clinical Research Associate / Monitor
- Clinical Data Management
- Introduction to Medical Writing
- Statistical Analysis and Clinical Trials
- Quality Assurance
Module IV: Clinical Research Management This module helps you understand the management aspects of clinical research including the important decisions to be taken during the conduct of a clinical trial, the pitfalls to avoid and the importance of quality management in clinical research. It will also explain the processes to undertake in order to successfully conduct and complete a clinical trial. Contents of Module IV
- How to Manage Clinical Trials
- Pitfalls in Clinical Research — How to Avoid Them.
- Clinical Research – Decision Making Tools
- Quality Management in Clinical Research
- Prescription for the Success in Clinical Research
Module V: Professional Development and Career Skills The knowledge and skills you gain from this module will make you a better professional. The clinical research employers are on a constant look out for candidates with this professional edge. Contents of Module V Career Skills
- Taking Charge of Your Career
- Preparing a Winning Resume/CV
- Interview Cracking Skills
- Starting a New job
Professional Development Skills
- Professional Development and Planning
- Effective Communication Skills
- Time Management
- Tools for Decision Making
- Problem Solving
- Introduction to Six Sigma
- Action Learning
- Leadership Development
How the Course Works
Your clinical research course takes place in LEADS online platform. You read from the printed course material provided and complete the weekly activities online. You’ll be provided with personal login. You can log in at any time at your convenience. You will communicate with your instructor and fellow students, talk about different topics via discussion boards, read assigned texts, access course digital resources, and submit your assignments all through the online learning system. Once you complete all the weekly activities, you’ll receive a hard copy of the printed certificate at your doorsteps. The activities to be taken up by the students are:
- Reading Activity
All students have access to a well-stocked online library on clinical research with periodicals, newsletters and journals
Course Fee and Duration
Course Duration: 6 Months (24 weeks) Course Investment: INR 19,750 for Indian students and USD 310 for International students. Registrations are open throughout the year.
Who Should Join the PCCRM Course?
- Graduate or a Postgraduate in any of the following streams: Pharmacy (B.Pharm, M.Pharm), Medicine (MBBS, MD), Dentistry (BDS, MDS), Physiotherapy (BPT, MPT), Ayurveda (BAMS), Homeopathy (BHMS), Nursing, Life sciences (Microbiology, Biotechnology, Biochemistry, Lab science, Genetics, Nutrition, Botany, Zoology).
- Professionals working in clinical research to get better hold on the fundamentals.
- Health care professionals in other streams looking for change in career.
- Professionals and students keen to add research education/qualification to their profile.
- Graduates with minimum of 45% aggregate marks in graduation or post graduation
- Students doing their internship (house surgeon)
- Final year graduation students can also apply
“The training was fabulous. It was a great learning experience.”
Dr.Prashanth BDS, MHIM (Licensed UK Dentist)
How to Join PCCRM Course
- Download the Free Prospectus & Application
We fully support till you successfully complete.
“A very informative course which not only enabled me with the essential skills of clinical research but also helped me choose the vertical which suits me best in the clinical research industry.”
Dr. Suhas, CRA
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Free eCourse on Clinical Research