Monday, 4 March 2024

Eastern European Clinical Trials Market: Overview and Country Breakdown

 

Market Size and Growth:

The Eastern European clinical trials market is estimated at USD 6-8 billion as of 2023 and is projected to reach USD 10-12 billion by 2028, growing at a CAGR of 6-8%. This growth is driven by:

  • Large and accessible patient population: Over 200 million people with diverse demographics offer valuable data.
  • Cost-effectiveness: Lower labor costs compared to Western Europe make trials more affordable.
  • Streamlined regulations: Simplified approval processes in some countries attract sponsors.
  • Strong academic research base: Renowned universities and research institutes provide expertise.
  • Focus on innovative therapies: Increasing participation in Phase II and III trials for new drugs.
Key Players:

Clinical trials must adhere to stringent regulations and guidelines set by various authorities worldwide. Some key regulatory bodies include:

  • Pharmaceutical and biopharmaceutical companies: Global giants like Roche, GlaxoSmithKline, and Sanofi are active alongside regional players like Gedeon Richter.
  • Contract research organizations (CROs): International CROs like Parexel, Iqvia, and Syneos Health have major shares, with regional players like Synexus Clinical Research gaining traction.
  • Clinical research sites: University hospitals, specialized research institutes, and private clinics form the research infrastructure.
Number of People Employed:

Estimates suggest over 800,000 people are directly or indirectly employed in the Eastern European clinical trials market. This includes researchers, clinicians, nurses, data analysts, project managers, and administrative personnel.

Key Trends:

Clinical research relies heavily on comprehensive documentation, including:

  • Decentralized clinical trials: Increasingly popular to improve patient access and reach diverse populations.
  • Focus on therapeutic areas: Oncology, autoimmune diseases, and infectious diseases lead the way.
  • Adoption of digital technologies: Telemedicine, AI-powered platforms, and e-consent enhance efficiency and data management.
  • Increased data sharing and collaboration: Initiatives like EU Clinical Trials Regulation promote cross-border research.
  • Emphasis on patient-centricity: Engaging patients in trial design and decision-making is becoming crucial.
Country Breakdown:
CountryMarket Size (USD billion)Key Players
Poland2.5-3Polpharma, Bio-Gen sp. z o.o., Novartis, Roche
Czech Republic1-1.5Zentiva, Pfizer, Quintiles, Parexel
Hungary0.5-1Gedeon Richter, TEVA, Sanofi, Syneos Health
Bulgaria0.2-0.5Actavis, Abbott, Synexus Clinical Research
Romania0.2-0.5Antibiotice S.A., Roche, IQVIA, PRA International
Challenges:
  • Varied regulatory landscape: Differences in regulations necessitate careful navigation across countries.
  • Limited awareness of clinical trials: Public education and engagement initiatives are needed.
  • Skilled workforce shortages: Investing in training and development is crucial.
  • Language barriers: Multilingual personnel are essential for effective communication.

Eastern Europe offers a burgeoning market for clinical trials with considerable potential. Understanding the nuances of individual countries and addressing the challenges will be key for success in this dynamic region.

Overview of the Japanese Clinical Trials Market

 

Market Size and Growth:
  • The Japanese clinical trials market is the third largest in the world, valued at USD 10.9 billion as of 2020.
  • It is projected to reach USD 18.0 billion by 2025, growing at a CAGR of 5.7%.
  • This steady growth is driven by several factors:
  • Clinical trials: Involve testing the drug on human volunteers in a series of meticulously designed phases:
    • Aging population: Japan has the world's oldest population, creating a high demand for new drugs and treatments for age-related diseases.
    • Advanced healthcare infrastructure: Japan boasts modern hospitals and a highly skilled medical workforce, providing a platform for high-quality clinical trials.
    • Strong pharmaceutical industry: Japanese pharmaceutical companies like Takeda and Astellas invest heavily in R&D, leading to more clinical trials.
    • Streamlined regulatory system: Recent reforms have made the clinical trial approval process faster and more efficient.
Key Players:
  • Domestic pharmaceutical companies: Takeda, Astellas, Eisai, and Daiichi Sankyo are major players conducting and sponsoring clinical trials in Japan.
  • International pharmaceutical companies: Global giants like Pfizer, Novartis, and Roche are increasingly conducting trials in Japan due to its attractive market size and efficient regulatory system.
  • Contract research organizations (CROs): IQVIA, Parexel, and Syneos Health are leading international CROs with a strong presence in Japan. Domestic CROs like Quintiles Japan and Sosei Clinical Research are also gaining prominence.
  • Clinical research sites: University hospitals, private hospitals, and research institutes comprise the majority of clinical research sites in Japan. The National Cancer Center Hospital and the University of Tokyo Hospital are among the most renowned research institutions.
Number of People Employed:

Several key players contribute to the success of clinical research:

  • Direct and indirect employment in the Japanese clinical trials market is estimated to be around 600,000 people. This includes researchers, clinicians, nurses, data analysts, project managers, and administrative personnel.
  • The demand for skilled professionals in the clinical research field is expected to rise further, driven by the market's growth.
Key Trends:
  • Decentralized clinical trials: Gaining traction in Japan, offering greater convenience and access to patients in rural areas.
  • Focus on rare diseases and personalized medicine: Addressing unmet medical needs for smaller patient groups and tailoring treatments to individual patients.
  • Adoption of digital technologies: Artificial intelligence, telemedicine, and e-consent platforms are being used to enhance trial efficiency and data management.
  • Increased data sharing and collaboration: Initiatives like the Japan Clinical Research Information System (JCRIS) are facilitating data sharing and collaboration between researchers.
  • Emphasis on patient-centricity: Increasing focus on involving patients in trial design, decision-making, and outcome reporting.
Additional Points:

Identifying and reporting adverse events associated with a drug is crucial throughout its development and post-marketing surveillance.

Ethics: The Bedrock of Research

Maintaining the highest ethical standards is paramount in clinical research. Key principles include:

  • Japan accounts for roughly 4.7% of global clinical trial activity.
  • The SAKIGAKE program fast-tracks the approval process for innovative drugs with significant unmet medical needs, making Japan attractive for early-stage drug development.
  • Ethical considerations and patient safety remain critical priorities in the Japanese clinical trials market.

The Japanese clinical trials market offers a unique and promising environment for research and development. Understanding the key trends and challenges will be crucial for both domestic and international players to capture the opportunities in this evolving market.

Sunday, 3 March 2024

Global Pharmacovigilance: Ensuring Drug Safety for a Growing Population

 

1. Total Market Size:

The global pharmacovigilance market is projected to reach a staggering USD 24-30 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 8-12%. This exponential growth is driven by several factors, including:

  • Rising prevalence of chronic diseases: As populations age and unhealthy lifestyles become more prevalent, the demand for new drugs and increased focus on drug safety escalate.
  • Stringent regulatory frameworks: Regulatory bodies like the FDA and EMA are continuously strengthening pharmacovigilance requirements, ensuring thorough monitoring and adverse event reporting.
  • Technological advancements: Artificial intelligence (AI), machine learning (ML), and Big Data analytics are revolutionizing data analysis, enhancing signal detection and improving safety monitoring efficiencies.
  • Globalization of clinical trials: Increased outsourcing of clinical trials to regions with diverse patient populations necessitates robust pharmacovigilance systems to capture drug safety data across various demographics.
2. Market Size by Region:
2.1 North America (US & Canada):
  • Market size: USD 9-11 billion (dominated by the US market due to strict regulations and large-scale research activities).
  • Key drivers: Focus on early-phase trials, large patient pool, rising chronic diseases.
  • Sub-segments: Spontaneous reporting, signal detection, risk management, data analytics.
2.2 Europe:
  • Market size: USD 6-8 billion (driven by mature regulatory frameworks and a strong emphasis on patient safety).
  • Key drivers: EMA regulations, aging population, decentralized clinical trials.
  • Sub-segments: Pharmacovigilance planning, adverse event reporting, signal management, compliance.
2.3 Asia:
2.3.1 Japan:
  • Market size: USD 3-4 billion (boosted by an aging population, advanced healthcare infrastructure, and government support for R&D).
  • Key drivers: Aging population, strong pharmaceutical industry, regulatory updates.
  • Sub-segments: Pharmacovigilance system updates, risk management plans, drug safety communication.
2.3.2 China:
  • Market size: USD 4-5 billion (experiencing rapid growth due to a vast patient population, increasing R&D investments, and regulatory reforms).
  • Key drivers: Rapidly growing pharmaceutical market, government initiatives, local talent acquisition.
  • Sub-segments: GCP compliance, pharmacovigilance infrastructure development, regulatory consultancy.
2.3.3 India:
  • Market size: USD 1.2-1.5 billion (attracting attention due to cost-effective clinical trials and a large diverse patient population).
  • Key drivers: Cost-effectiveness, government initiatives, large patient pool.
  • Sub-segments: Medical coding of adverse events, data management, regulatory consultancy.
2.3.4 Southeast Asia:
  • Market size: USD 0.7-1 billion (emerging market with rising awareness, improving healthcare infrastructure, and government support).
  • Key drivers: Regulatory harmonization, government initiatives, local service providers.
  • Sub-segments: Training programs, local regulatory expertise, clinical trial support.
2.4 Other Regions:
  • Australasia & Oceania (Australia & New Zealand): USD 0.4-0.5 billion (mature market with stringent regulations and focus on ethical considerations).
  • Eastern Europe: USD 0.5-0.6 billion (growing market with lower costs and diverse populations, but faces language barriers and varied regulations).
  • Latin America: USD 0.6-0.8 billion (potential for growth due to large patient pool and R&D activities, but needs improved infrastructure and skilled workforce).
3. Employment in Pharmacovigilance:

The global pharmacovigilance industry employs over 2 million people directly or indirectly, with regional variations in numbers and salary expectations.

3.1 Major Employment Hubs:
  • US: 40,000-60,000 (high demand for skilled professionals, competitive job market).
  • Europe: 30,000-40,000 (strong presence of specialized CROs and pharmacovigilance service providers).
  • Japan: 15,000-20,000 (emphasis on regulatory compliance and local expertise).
  • China: 20,000-30,000 (rapid growth, increasing demand for qualified professionals, talent development initiatives needed).
  • India: 10,000-15,000 (growing market, skillset gap exists, potential for job
4. Current and Future Pharmacovigilance Trends:
4.1 Global Trends:
  • Digitalization: AI, ML, and Big Data are revolutionizing data analysis, improving signal detection, and enabling real-time safety monitoring.
  • Decentralized Clinical Trials (DCTs): Increased adoption of DCTs to improve patient access and data diversity, necessitating robust remote pharmacovigilance solutions.
  • Patient-Centricity: Patients are becoming more involved in safety reporting and decision-making, leading to the development of patient-friendly reporting tools and engagement strategies.
  • Real-World Data (RWD): Growing usage of RWD from electronic health records and wearables to complement traditional clinical trial data and provide insights into drug safety in real-world settings.
  • Harmonization of Regulations: Efforts to standardize pharmacovigilance regulations across regions are underway to streamline global processes and improve drug safety information exchange.
4.2 Regional Trends:
  • US: Focus on personalized medicine, early-phase trial safety, and active safety surveillance (PASS).
  • Europe: Emphasis on compliance with EMA regulations, post-marketing surveillance, and risk management plans.
  • UK: Brexit impact on regulatory landscape will be closely monitored, along with increased R&D in niche therapeutic areas.
  • India: Cost-effectiveness remains a key driver, along with government initiatives to improve pharmacovigilance infrastructure and training.
  • Japan: Focus on aging population and geriatric drug safety, along with regulatory updates and local data utilization.
  • China: Rapid growth driven by government support for R&D and increased regulatory compliance requirements.
  • Australia & Canada: Focus on maintaining high ethical standards and patient safety in clinical trials, alongside adoption of digital technologies.
  • Southeast Asia: Rising awareness of pharmacovigilance, regional regulatory harmonization efforts, and development of local service providers.
  • Eastern Europe: Potential for growth due to lower costs and diverse populations, but challenges include varied regulations and language barriers.
  • Latin America: Improving infrastructure and skilled workforce needed to capitalize on the large patient pool and growing R&D activities.
5. Key Pharmacovigilance Service Providers:
  • IQVIA: Global leader with comprehensive solutions for pharmacovigilance, drug safety, and compliance.
  • Parexel: Strong expertise in global safety solutions, clinical research, and data management.
  • Syneos Health: Integrated approach combining clinical development, commercialization, and pharmacovigilance services.
  • Exco InTouch: Dedicated pharmacovigilance solutions with a focus on risk management and signal detection.
  • WuXi AppTec: Leading player in China with global reach, offering integrated R&D and pharmacovigilance services.
  • Aptiv Solutions: Specializes in drug safety technology and data analytics, supporting pharmacovigilance processes.
  • Covance: CRO with strong pharmacovigilance capabilities, experience in global clinical trials.
  • PRA Health Sciences: Global CRO offering pharmacovigilance services alongside clinical research expertise.
  • ICON plc: Provides end-to-end drug development solutions, including comprehensive pharmacovigilance offerings.
  • Veeva Systems: Cloud-based life sciences platform providing Veeva Vault Safety for pharmacovigilance data management.
6. Major Pharmacovigilance Software:

The global clinical research market is expected to reach $76.8 billion by 2027, with significant activity in:

  • TARAPV : TARA PV is a fully functional system offering an interface that is consistently simple, intuitive and most importantly, a user-friendly cloud based pharmacovigilance solution.
  • Argus Safety: Widely used platform for safety data management, reporting, and signal detection.
  • Oracle Argus Cloud: Cloud-based version of Argus Safety offering scalability and accessibility.
  • Pharmatix Vigilance Safety Suite: Comprehensive safety data management system with global regulatory compliance features.
  • Medidata Safety Connect: Cloud-based safety platform with clinical trial integration and data visualization tools.
  • Veeva Vault Safety: Part of Veeva Systems' platform, offering cloud-based safety data management and regulatory compliance tools.
  • SafetyNet by Almac Group: Comprehensive pharmacovigilance software with advanced analytics and reporting capabilities.
  • AERIS by OpenText: Cloud-based pharmacovigilance platform with global functionality and regulatory compliance features.
  • Evisort by MedTech Innovator: AI-powered pharmacovigilance software for enhanced signal detection and risk management.
  • Drug Safety Cloud by Exco InTouch: SaaS platform for risk management, signal detection, and regulatory compliance.
  • SafetyWatch by Aptiv Solutions: Cloud-based pharmacovigilance platform with integrated risk assessment and signal management tools.

This detailed overview provides insights into the current and future trends shaping the global pharmacovigilance landscape. With technological advancements, regulatory harmonization efforts, and patient-centricity gaining momentum, the pharmacovigilance industry is poised for significant growth and transformation in the years to come.

Monday, 21 November 2022

HOW TO SELECT THE RIGHT INSTITUTE & PROGRAM FOR YOUR CAREER

Selecting the right institute and program is key to success in your professional life. The right program from the right institute can help us in reaching the top of your career. At the same time selecting a non-accredited program from a non-authorized institute without a proper background check or just based on lucrative and false promises or low-fee offers may ruin your career or may force you to reinvest your money and time to study the same program again, leaving you to fall behind in the race of life. Thus, it is very important to analyze the program and institute on various parameters before enrolling into that. Today we will discuss a few factors, which may be taken into consideration or avoided while selecting any program or institute.

PROGRAM – While searching for any Job/Career oriented program, it must be checked whether the program is accredited by any Government authority or some International organization of repute with global acceptance. It should also be verified, whether the program is aligned with industry requirements and accepted by them or not. The simplest way is to check the placement track record of the institute. Here you can analyze the acceptance of the program of the institute by companies.   

INSTITUTE – In the present market every organization are claiming to be the best, even with very less or no track record. It becomes very important to do a fact check of the institute before enrolling into their program. There are a few parameters any institute must be tested upon.

           Background: The background of any institute matters the most. The people behind the organization and their vision decides the foundation and ethics of the organization. You should check whether the founders are from a similar background and dedicated towards the industry or it’s just a money-making organization.   

           History: The history of any organization is very important to be checked. The institute with a longer presence in the market proves its acceptance by the industry.

          Placement record – Always ask for the placement record of the institute. A good record reflects that its programs and well-designed and accepted by the industry and the team of trainers are well qualified.

          Feedback – Try to get feedback from the ex-students and industry people, who have been part of the institute. They are the people who give you a clear idea about the institute.

          Accreditation: This is the most important part of any program. A degree without any accreditation has no value in the real world. You must check for any govt or international accreditation of the program, the institute is offering.

      Industry Acceptance: Any program without acceptance from the industry is of no value. You must enquire, how well the students of the institute are absorbed/hired by the industry. Institutes with good placement records should easily be trusted. Students should not select any institute without proper placement records

VALUE PROPOSITION: Any program/institute should never be rejected or selected just based on Fee. If you find the fee of any institute high, you should give it a consideration that why in this competitive world they have kept their fee high from others. There are various factors, which make the program fee higher. So rather than deciding just on fee, you should go to analyze the value proposition of the program. You should consider the following point before rejecting any program/institute.

  • Program design
  • Accreditation
  • Faculty
  • Live projects/Internship
  • Industry linkages
  • Placement Support
  • Hiring Companies
  • Salary offered after the program
  • Career growth of the past students

PLACEMENT: This is the one of most important factor, which makes any program/institute eligible to be selected by students. You must ask the institute to share their recent placement records with the LinkedIn profile of the students. Institute must provide continuous placement assistance and arrange interviews with the recruiters. Ask their process of placements, cv writing, pre placement training, mock interviews, aptitude test prep and many other pre placement activities.

COUNSELLING – Counselling plays a very important role in selecting the right program or right career. The students should always consult a person with proper industry knowledge and exposure. They should never select any institute or program just on the advice of a friend or family, who are not an industry expert. Rather you should consult experts from any reputed institute or a career counsellor.

CERTIFICATION: If any organization is not offering a program with proper certification authorized by any Government body or accreditation organization, you should avoid enrolling in such programs.

PROGRAM ADD-ON – You should always look for some additional facilities/support with the program. Such as

  • Multiple Certification
  • Live projects
  • Real Software training
  • Industry Internship
  • Pre-Placement training
  •  Assure Placement support

 

Author:

Rajesh k Singh,

Head – Business Development

Cliniminds

 

Rajesh k Singh has 20+ years of experience in education and allied industry. He has worked with many universities and institutes of repute in teaching & senior management positions. Mr Singh has vast experience in career counselling. He loves guiding students in selecting the right career path. His guidance has helped many students to achieve better career goals in their life. 

Wednesday, 1 July 2020

MEDICAL WRITING – INTRODUCTION

By Dr. Suneet Sood, Monash University & Kamal Shahani, Cliniminds

In the series of short write ups on a medical writing career, we would cover various aspects of medical & scientific writing. This first article covers the introduction and the scope of medical writing.

 Medical writing is, in its broadest sense, writing for the healthcare and life sciences industry. The term “writing” included only the print medium, but now also includes any writing work that is carried out for television (e.g. advertisements), radio (e.g. speeches), and internet. Healthcare related typically refers to medicine, but medical writers also involve themselves in writing for agriculture and veterinary related content.

In this short write up, we would cover the scope and types of medical writing.

 The Scope of Medical Writing

 For persons who wish to become medical writers, the scope is immense. 

Medical writing is today a billion-dollar industry.

The writer can involve themselves in one of two types of writing:

1.      Regulatory Writing        

2.      Publication Writing

Medical writing is conventionally classified into these two types, because the laws governing regulatory writing are considerably more stringent than those governing publication writing. Consequently, someone who is involved in regulatory writing is more likely to require a formal training course than one who will confine themselves to publication writing.

Having said that, everyone needs training!

Regulatory writing is that which is typically carried out by the contract research organizations for the pharmaceutical industry or by the pharmaceutical companies for regulatory compliances. They typically create large texts for firms conducting drug trials. Today the ethical constraints for all trials are so tight that there is a large body of rules that guides this form of writing. The rules ensure that the documents adhere to the International Conference of Harmonization’s Good Clinical Practice guidelines. Medical writers at Pharmaceutical companies write several regulatory documents for submissions to various global regulatory agencies.

Thus, a medical writer involved in regulatory writing will prepare clinical trial reports, write out the investigator brochures, generate new drug applications, compile annual reports, write out clinical study reports, and so on.

In contrast, the medical writer who focuses on publication writing will typically write for magazines, journals, even books. Publication writing includes pharmaceutical marketing and advertising, writing magazine articles, and so on, for the public (see box). Publication writing includes newsletters, speeches, posters, abstracts and other journal content, educational materials, compilation of drug monographs, internet content, and ghostwriting, as well as editing and other activities of publishing houses.

Publication writing

Pharmaceutical marketing and advertising

Magazine articles

Professional Newsletters

Physician speeches Posters

Conference Coverage

Journal abstracts and articles Medical education materials Patient educational materials Internet content

Editing, proofing, publishing Ghostwriting

The debate is not whether there is enough work for medical writers. The debate is, “is there a limit?” Medical writers can get jobs in pharmaceutical companies, contract research organizations, agencies that specialize in communications work, content providers, or institutions that cater for education. Freelance writers have a high demand if they are good. The most skilled writers will create content. Medical writers will also be editors and proofreaders, and may have a role in marketing for medical products. However, all writers should aim to become content creators. Medical writing is a sort of business. Skill, marketing, and durability in the profession make a great difference. Still, the rewards are good overall. In United States of America medical writers earn between US$60,000 and 100,000 or more annually. In India medical writers earn between Rs.400,000 and 20,00,000 or more annually depending upon your level and experience. A lot depends on the market a writer targets. Most of the better earners will have taken a writing course. Very few top earners will be self-taught. As professionals, most should be members of an established medical writing institution/ association.

The scope for publication writing is also immense. One can produce advertising articles, internet content, magazine articles, marketing materials, newsletters, training manuals, and more.

Publication writing itself is directed at two main audiences: the public (popular) and the scientific (professional). Writing for the public includes content for popular newspapers and magazines, educational materials, advertising products such as flyers, and others. Scientific writing includes content for newsletters, reviews for journals that cater to practitioners, and internet content for professionals. Scientific writing may even include writing for specialty medical journals, and medical writers are lobbying hard to make it acceptable for investigators to enlist their services to produce medical papers.

For those who are interested in taking medical writing more seriously, even as a profession, the question we need to address is: are there jobs for medical writers? The answer is, “Of course there are jobs.” Writing for The pharmaceutical and clinical research industry itself is a multibillion dollar business. A simple Google search showed that the industry turnover has multiplied since the nineties. The same holds true for publication writing.

Formal training in medical and scientific writing is important for the professionals who would like to take a plunge in medical writing career or medical doctors who would like to conduct and publish their research. A formal training course would be helpful.


About Cliniminds : Cliniminds offers wide range of health sciences programs since 2004. Cliniminds also offers specialized program in Medical & Scientific Writing. Next batch for Live eLearning is commencing from Sunday, 2 August 2020. For more information, please contact info@cliniminds.com or +91 98100 68241.

Monday, 21 May 2018

CLINICAL TRIAL & 13 Principles of ICH GCP


In Clinical Trials to achieve Quality readiness one needs to understand the Principles of Good Clinical Practices. GCP has been well defined in EU Directive 2001/20/EC, under Clause 2 of Article 1, which discusses about scientific quality requirements for designing and conducting clinical trials.


The data obtained from Clinical trials should be credible as well Clinical trials should protect the rights, safety and wellbeing participating subjects as per National Research Act and Belmont Report, to ensure the authenticity of data and protection of human subjects The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created Good Clinical Practices in the year 1996, which eventually became mandatory to be followed in the year 2004 for conducting trials on all Investigational Medicinal Products (IMP).

Principles of GCP are summarized as follows

1.Clinical Trials should be conducted as per Declaration of Helsinki, which provides ethical guidelines on human experimentation.
2.Before the initiation of clinical trial, the risks for subject and society should be weighed against its anticipated benefits. 
3.The safety and rights of the participating subjects should considered with utmost importance over the benefits of trial. 
4.Clinical information and non-clinical information on the investigational medical product should be adequate to support the trial.
5.Specifics of clinical trials should be well defined and explained in Protocol
6.Protocol should be approved by Institutional review board (IRB)/independent ethics committee (IEC), following which clinical trial should be conducted in compliance with Protocol. 
7.During the trial, qualified physician would be responsible for the well the being of the subject 
8.The staff conducting the trail should be qualified in education, training and experience to perform task allocated to them.
9.Prior to the clinical trial signed informed consent should be obtained from the subject
10.To allow accurate reporting, interpretation and verification of clinical trial data, measures to and record and maintain the data should be sought out.
11.The records identifying the confidentiality of subject should be protected in respect to privacy and confidentiality regulations.
12.The Investigational medicinal product in Clinical Trials should be manufactured as per Good manufacturing practices (GMP) and should be used in accordance to the protocol. 
13.Quality systems should be maintained to ensure quality in Clinical Trials.

Reference: GCP 13 Principles
(Url:  https://www.abdn.ac.uk/hsru/documents/GCP%2013%20Principles.pdf )
Cliniminds (www.clinimids.com ) welcomes all the students and professional who are seeking a bright career in Clinical Research and Pharmacovigilance. We have 14 + years of lineage and our faculties are seasoned experts with vast experience from the Industry. We provide 100% assured placement support, for more information contact us @ 9560102587 or email us at pharmacovigilance@cliniminds.com

Wednesday, 16 May 2018

Clinical Research- opening new doors to Duchenne muscular dystrophy




Duchenne muscular dystrophy (DMD) is a muscular dystrophy characterized by severe muscle weakness due breaking of skeletal muscles. DMD mostly occurs in boys at around age of 4. The aetiology of DMD is said to be attributed to the mutation of a gene called dystrophin located at locus Xp21 or on Chromosome X. Dystrophin is responsible for connecting the cytoskeleton of each muscle, without dystrophin, excess calcium would enter into the cell and cause the cell to burst.
It was not too long before Erin realized that her two year old son Oliver Lambright was diagnosed with Duchenne muscular dystrophy, a generic disorder which occurs in one in 3000 boys. She looked at every possible treatment on the internet, only to realize that there was no cure, till she found Dr. Jean Mah, who was an Associate Professor at Cumming school of Medicine in the Department of Paediatrics, she told her family that there is ongoing clinical trial on DMD at the University of Calgary in Alberta, Canada in which around 100 patients with DMD from all over the world participated in the trial.

Clinical trials are essentials as it paves way for new line of treatment drugs. Before a drug is dispensed in a clinic,It has to undergo clinical trial. At the University of Calgary there are around 563 active trials.

Reference: UToday, University of Calgary
Cliniminds www.cliniminds.com has been on the forefront in delivering quality education in Clinical Trial Monitoring accredited from the Accreditation Council of Clinical Research Education- United States. Our course on Clinical Trial Monitoringcovers module on Clinical Research, Pharmacovigilance and Clinical Data Management. Our program comes with assured placement support.

Our Classroom sessions for new batch commences from 21st May 2018. Enrol now to avail 10% discount. For more information contact us at 9910068241, 9560665441, 9560102587or email us at info@cliniminds.com