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Become a Certified Clinical Research Professional (CCRP)

Join in Global Largest Clinical Research Certification Program

Scope of Clinical research: There is a huge growth in scope and career in clinical research these days. Any student with any education al background can pursue their career in Clinical research. There are bulks of jobs for the students after the completion of the course. For example one can opt for career as a Clinical Research Coordinator, Business Development, Medical Writer, Regulatory Affairs, Regional CRA, Senior CRA, pharmacovigilance, Clinical data manager and many more Beginners can earn around Rs.15000 per month and after 2 to 3 years of experience one can draw salary at Rs.4 to 5 lac per annum package. Statistics reveal that by 2008 up to 30% of the global clinical trial will take place outside Us and Europe and India is a favored destination, Clinical research professional has the potential to take a highly paying job, compared to other industries. Clinical research is big revenue earner for the country. It is estimated to grow into US$ 1 billion strong industry in India by 2010 with 50000 clinical research jobs in India and 2,50,000 jobs worldwide.

Introduction Clinical research is an essential component of the healthcare industry, providing valuable insights into the safety and efficacy of new drugs and therapies. The scope of clinical research is vast, covering a range of therapeutic areas and patient populations. Asia, Africa, and EU countries are all significant players in the global clinical research industry, each with its unique opportunities and challenges. This article will explore the scope of clinical research in these regions and the current trends and challenges.

Scope of Clinical Research in Asia:

Asia has emerged as a crucial location for clinical research, driven by its large population, growing middle class, and increasing burden of chronic diseases. The scope of clinical research in Asia covers a broad range of therapeutic areas, including infectious diseases, oncology, cardiology, and neurology. The region also conducts clinical trials on traditional medicines and herbal remedies, which are widely used in many Asian countries.

Japan, South Korea, and Singapore are highly developed countries with excellent research infrastructure and regulatory frameworks, making them popular locations for clinical trials. China is also emerging as a major player in clinical research, with the government investing heavily in research infrastructure and streamlining regulatory processes. However, other countries in Asia, such as India and Indonesia, face challenges such as inadequate research infrastructure, regulatory delays, and ethical concerns.

Infectious diseases, including HIV/AIDS, malaria, and tuberculosis, are prevalent in many parts of Asia. Clinical research in these areas is critical in developing new treatments and therapies to combat these diseases. The rising incidence of non-communicable diseases, such as diabetes, cancer, and cardiovascular diseases, also presents significant opportunities for clinical research in the region.

The Asia-Pacific region is expected to experience significant growth in clinical trials in the coming years. According to a report by GlobalData, the number of clinical trials in the region is expected to increase by 10.4% annually, reaching 18,800 trials by 2025. The growth is driven by increasing investments in research and development, favorable regulatory frameworks, and the region’s large patient population.

Scope of Clinical Research in Africa : Clinical research in Africa is growing rapidly, driven by the increasing burden of disease and a growing interest in global health. The scope of clinical research in Africa includes a range of therapeutic areas, including infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, as well as non-communicable diseases, such as diabetes, cancer, and cardiovascular diseases.

Clinical research in Africa also includes research on traditional medicine and indigenous healing practices, which are widely used in many African countries. However, the region faces challenges such as inadequate research infrastructure, limited funding, and a lack of trained personnel.

To address these challenges, there have been efforts to strengthen research infrastructure in Africa, including the establishment of research centers and the training of researchers and clinical trial personnel. The African Union has also launched initiatives to promote health research and innovation on the continent.

Infectious diseases remain a significant health burden in Africa, and clinical research in these areas is essential to developing new treatments and therapies. The region has made significant strides in HIV/AIDS research, with several groundbreaking studies conducted in recent years. The growth of non-communicable diseases in the region also presents significant opportunities for clinical research.

The growth of clinical research in Africa has been significant in recent years, with a 31% increase in the number of clinical trials conducted between 2013 and 2018. However, the region still lags behind other regions in terms of clinical trial activity, accounting for only 2% of global clinical trials.

Scope of Clinical Research in EU Countries:  The European Union (EU) has a well-established clinical research industry, with a robust regulatory framework for clinical trials and

a strong research infrastructure. The scope of clinical research in EU countries covers a range of therapeutic areas, including oncology, cardiology, neurology, and infectious diseases. The region also conducts clinical research on rare diseases, which affect a small percentage of the population but require specialized treatments and therapies.

The EU has a centralized regulatory framework for clinical trials, with the European Medicines Agency (EMA) responsible for authorizing clinical trials and approving new drugs and therapies. The EMA also provides guidance on ethical considerations and patient safety, ensuring that clinical research in EU countries adheres to strict ethical and safety standards.

The EU is home to many leading research institutions, including universities, hospitals, and pharmaceutical companies, providing access to world-class researchers and clinical trial sites. However, the region faces challenges such as high research costs, regulatory hurdles, and a shortage of clinical trial participants.

The COVID-19 pandemic has highlighted the importance of clinical research in EU countries, with several vaccines and therapies developed in record time. The pandemic has also led to changes in the regulatory framework, with the EMA introducing accelerated approval processes for COVID-19 treatments and vaccines.

Conclusion Clinical research plays a crucial role in the healthcare industry, providing valuable insights into the safety and efficacy of new drugs and therapies. The scope of clinical research in Asia, Africa, and EU countries covers a broad range of therapeutic areas and patient populations, each with its unique opportunities and challenges.

Asia has emerged as a key location for clinical research, driven by its large patient population and growing middle class. The region is expected to experience significant growth in clinical trials in the coming years, driven by increasing investments in research and development and favorable regulatory frameworks.

Africa is also experiencing significant growth in clinical research, driven by the increasing burden of disease and a growing interest in global health. The region faces challenges such as inadequate research infrastructure and limited funding but has made significant strides in HIV/AIDS research and presents significant opportunities for clinical research in non-communicable diseases.

The EU has a well-established clinical research industry, with a strong regulatory framework and research infrastructure. However, the region faces challenges such as high research costs and a shortage of clinical trial participants. The COVID-19 pandemic has highlighted the importance of clinical research in the region, with several vaccines and therapies developed in record time.

Overall, the scope of clinical research in Asia, Africa, and EU countries is vast, and the industry is expected to continue to grow in the coming years, driven by increasing investments in research and development and a growing demand for new treatments and therapies.

Scope for life science and Pharma students in clinical research: An understanding of the fundamental principles of biology is very essential for the Clinical research. Life science students involve in many experimental techniques, use instruments and reagents. Hence this research can generate new hypothesis and propel in new studies. So many life science and pharma graduates are being absorbed in many Pharma companies where Clinical trials are conducted.

Scope for doctors, physicians in Clinical research: Not only does the Life science students gain jobs in Clinical research field, but also doctors, physicians etc. For example a doctor can administer the right drug to patient at right times and he knows what is the dose required for a particular patient. They also have a good understanding on the chemistry of the disease. Thus Clinical research is an equal opportunity provider for all the students pursued their education in either of the fields.

CCRP

About this course

CCRP, Global Largest Clinical Research Certification Program

  • One certification, SCRP- CCRP, for clinical research professionals: No need to obtain multiple certifications when you transition to varying roles in the clinical research arena. The scope of the Certification Program is based on the principles of Good Clinical Practice, including the US Code of Federal Regulations, ICH GCP E6, and the Ethical Principles that guide clinical research (Belmont report, Declaration of Helsinki and the Nuremberg Code).
  • One certification covers: human clinical research of pharmaceuticals, biologics, medical devices and behavioral research within the US or internationally.
  • Available to members and non-members: If you are already a SCRP member, your certification is offered at a reduced cost. If you are not a member, you receive complimentary membership when you pass the exam.
  • Available to all persons working in clinical research (whether you are independent or affiliated with a research institution, CROs, SMO, sponsor, or government) including: 

Clinical investigators, coordinators, data managers, monitors, auditors, research nurses, pharmacists, project managers, statisticians, IRB and regulatory staff, regulators and government investigators, other clinical research professionals, Year-round testing available:

SCRP Sponsored Exams:  Computer Based Testing – Testing Centers or New! Home Proctoring,  Host an exam at your site

  • Administered independently by the Certification Committee: As a professional certification organization, SCRP and its Certification Committee act in the public interest by establishing and enforcing education, examination, experience and ethics requirements for certification.
  • Eligibility: There are multiple ways to qualify for the exam through your professional and educational experience.
  • CCRP Certification period: Your CCRP certification period is 3 years (with three year installment plan available).
  • Recertification: Maintain your certification through your professional experience and continuing education. Certificants must have completed 45 hours (45 credits) of CE during their certification period.

 

  • Administered independently by the Certification Committee: As a professional certification organization, PHARMA RESEARCH- SCRP and its Certification Committee act in the public interest by establishing and enforcing education, examination, experience and ethics requirements for certification.

 

  • Industry Recognized and Accredited:

PHARMA RESEARCH SCRP is accredited by International Accreditation Council for Clinical Research & Education (IACCRE) for demonstrating compliance with the IACCRE Standards for the Accreditation of Certification Programs.
TransCelerate BioPharma recognizes the SCRP- CCRP designation as evidence of Good Clinical Practice (GCP) training.

Module-1 : Clinical Research

  • Introduction to Clinical Trails ,
  • Overview ICH GCP
  • 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

Module-2 : Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Signal Detection and causality assessment
  • Statistical reasoning and algorithms in pharmacovigilance
  • Medical dictionary for Drug Regulatory Activities (MedDRA)
  • Individual Case Safety Report (lcsrs)
  • Periodic Safety update report (PSUR)

Module-3 : Drug Regulatory Affairs

  • Overview of Regulatory Environment in India, US, Aus, EU
  • Clinical Trial Requirement in India
  • Import-Export of Clinical Trial Drugs
  • HIPAA Privacy Rule
  • INDIA/ANDA/New Drug Application

Module-4 : Clinical Data Management

  • Introduction to Clinical Data Management
  • Clinical Data Management
  • Medical Coding in Clinical Data
  • Clinical Data Process
  • Case Reporting Form
  • Quality & Regulatory system

– 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.

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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@pharma-research.in. Request to take the online exam can be sent at any time.
  1. 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
  1. 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.
  1. How to enroll and pay the fee?
    To enroll, you simply need to view the link HOW TO ENROLL.
  1. 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@pharma-research.in

You can also view our FAQs page for further queries.

CCRP

Certified Clinical Research Professional

Duration: 12 Months

Fee: ₹ 41999/-

For Admission & Registration

INTERNATIONAL STUDENTS – PAY through PAYPAL


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