PC101: Professional Certificate in Clinical Research

Advanced PG Diploma in Clinical Research, Pharmacovigilance & Clinical Data Management

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The Advanced PG Diploma in Clinical Research, Pharmacovigilance & Clinical Data Management is a comprehensive 12-months online program designed for graduates in pharmacy, life sciences, medicine, nursing, and allied health fields. This course offers in-depth training in key areas such as clinical research processes, regulatory compliance, trial management, clinical data workflows, and pharmacovigilance, including MedDRA coding and safety report processing. Delivered entirely online, it allows students to study at their convenience, with lifetime access to professionally developed eBook materials. Accredited and globally recognized, the program includes module-wise assessments, online certification, and performance tracking. Students also benefit from placement assistance, resume support, and job alerts through industry partnerships. This diploma prepares learners for roles such as Clinical Research Associate, Drug Safety Associate, Clinical Data Manager, and Regulatory Affairs Executive across pharmaceutical companies, CROs, hospitals, and global healthcare organizations

Admission Open - For Registration

Indian Students enroll Your course from here

FEE: 24,999/-

Course Overview

About this course

The demand for clinical trials is expected to hit a market value of $64B by 2020 compared to the present value of $38.4B. The market is expected to reflect CAGR at 9% between 2015 and 2020. Currently, ClinicalTrial.gov lists more than 200,000 trials worldwide, creating a number of career options for clinical trial operations and related fields. The Professional Certification in Clinical Research (PCCR) course allows learners to gain in-depth knowledge of the relevant ICH-GCP and regulatory requirements, clinical trial study methods, duties and responsibilities of various stakeholders, reporting procedures, terminology, etc. This course will allow clinical research candidates and working professionals to succeed in their careers as Clinical Trial Operations Coordinator (CRC), Clinical Research Associate or Clinical Trial Investigators.

Who Should Take This Course?

Clinical Research Professionals
Aspirants (students/ working professionals) from following health science background: Pharmacy, Medicine, Dental, Nursing, Public Health, Life-Science, Physiotherapist, Traditional/ Alternative Medicine etc.

What am I going to get from this course?

12 high-quality learning modules with an online exam.
In-depth knowledge in applicable ICH-GCP and regulatory guidelines.
Learn various clinical trial study processes.
Learn roles and responsibilities of clinical trial personnel.
Certificate and Performance Card on successful completion.
Opportunity to explore your career in Clinical Research Operations.

International authors Clinical research, Phamacovigilance & Clinical Data Management eBooks lifetime accessibility

Curriculum

MODULE -1

Introduction to Clinical Research & Good Clinical Practice
Overview ICH GCP
Good Clinical practice
Clinical Trails
Institutional Reviews board
Investigation Responsibilities in clinical trails
Roles and Responsibilities of Sponsor & Clinical Trial Monitor
Informed Consent Process
Serious Adverse Event (SAE), Adverse event reporting
Site Initiation visit
Site close visit
Test Your Self
Apply Your Certificate

MODULE -2

Introduction To Clinical Data Management
CDMS
Medical Coding And Medical Dictionaries
Data Capture
Data Collection
Data Validation
Lab Data Management
Query Management
Electronic Case Report Form
Regulatory Systems
Quiz

MODULE -3

Introduction to pharmacovigilance
Signal detection and causality assessment
Statistical reasoning and algorithms in pharmacovigilance
Medical Dictionary for Drug Regulatory Activities (MedDRA)
Individual Case Safety Reports (Icsrs)
Pharmacovigilance Aggregate report
Periodic safety update report (PSUR)
Oracle Argus Safety – Theoretical Software Training
Online Examination

Eligibility

– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.

FAQs

What will be the mode of learning and do I need to visit anywhere to take this course?
The mode of learning is completely online and you are not required visit anywhere to take this course. You can easily learn and complete this course from your location. You should have a device (laptop/ desktop) with internet connect.

How will you deliver the course modules?
You simply need to log in with the Username and Password at our Online Moodle Portal to start learning. The access will be granted to you via email within 24 hrs. of fee payment.

I am a student at present; can I take this course along with my studies?
Yes, you can take this course along with your regular studies.

Is there any specific timing to take the course modules?
We have made it very convenient for you. All the course modules are pre-loaded on the website, so you can learn the modules as per your convenient timings.

How will you conduct the exams?
Exams will be online. Once you are through with course modules and want to take examination, you just need to drop a request mail at info@pharmaexa.com. Request to take the online exam can be sent at any time.

When will I receive the Certificate and Performance Card?
Once you attempt and submit your online exam for evaluation, we generally take 7 business days to evaluate and issue Certificate of Completion along with Performance Card

How will you send the Certificate of Completion?
The Certificate would be issued through email upon successful completion. The issued certificate would be print-ready but if you wish to receive a hard copy of Certificate then a minimal charge towards processing, printing and courier would be applicable.

How to enroll and pay the fee?
To enroll, you simply need to view the link HOW TO ENROLL.

Can I pay the fee in installments?
Yes, you can pay the fee in maximum 3 installments. To pay the fee in installments, you need to contact us at info@pharmaexa.com

You can also view our FAQs page for further queries.