Clinical Trial Supplies Market by Products & Services

Clinical Trial Supplies Market by Products & Services (Logistics & Distribution, Manufacturing, Packaging and Labeling), Phases (Phase I, Phase II, Phase III) & Therapeutic Areas (CNS & Mental Disorders, Cardiovascular, Oncology) - Global Forecast to 2020



The global clinical trial supplies market is expected to reach USD 1,274.3 Million by 2020 from USD 904.3 Million in 2015, at a CAGR of 7.1%. The global clinical trial supplies market is broadly classified into manufacturing services, packaging and labeling services, and logistics and distribution services. The logistics and distribution segment is expected to account for the largest share of the global clinical trial supplies products market in 2015.

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Wellness Supplements Market by Product (Dietary Supplements (Vitamin, Mineral, Protein, Herbal), - Global Forecast to 2020

Wellness Supplements Market by Product (Dietary   Supplements (Vitamin, Mineral, Protein, Herbal), Functional/Fortified Food & Beverages, Food Intolerance (Gluten-Free, Lactose-Free), Dermo-Cosmetic Skin Essentials (Anti-Acne)) - Global Forecast to 2020

The global Wellness Supplements market is expected to reach USD 249.4 Billion by 2020 from USD 183.1 Billion in 2015, at a CAGR of 6.4% during the forecast period. The growth of wellness supplement is mainly driven by factors such as rising geriatric population, growing prevalence of chronic diseases, rising awareness about benefits of wellness supplements, rising healthcare costs, and shift of consumers from care to preventive. However, regulatory compliance is likely to restrain the growth of wellness supplement market to a certain extent.

Clinical Trial Management System (CTMS) Market - Site Management, Billing & Patient recruitment, Cloud (SaaS) Global Trends, Opportunities, Challenges and Forecasts till 2016

A clinical trial deals with the application of specific clinical or scientific methods or medicine to the human body. Clinical trials are used to identify the effect of particular treatment or medication on patients suffering from a particular disease. The process of a clinical trial management system starts with identification of the medication or medical device to be tested. Participants for the trial are selected and the results are studied in order to define the effectiveness of the drug or device.

Clinical trials are very crucial as they involve huge capital investment and may affect the subjects involved. Thus proper management of clinical trials has become a priority for the hospitals. Clinical Trial Management System is a software system employed to manage the large amounts of data involved in a clinical trial. It maintains the planning, preparation, performance, and reporting of clinical trials, including participant information, trial and filing deadlines and other important milestones. The global market was valued at $576.22 million in 2010 and estimated to grow at a CAGR of 14.53% during the study period (2011-2016).

Improved clinical trial efficiency with optimized process; centralized database; improved site performance by enhanced investigator relationships; higher subject accrual rate & reduced workload for research coordinators; efficiency in budgeting and financial management; improved cost efficiencies; improved clinical research associate productivity; and automated data processing and report generating are some of the key advantages that are driving the market.

Clinical Trial Management System is used by the clinical trial organizations such as Pharmaceutical/Biopharmaceutical Companies, Clinical Research Organizations (CROs), and Healthcare providers (Hospitals, Academic Medical Centers (AMCs) which handle clinical trial. The pharmaceutical CTMS market contributed the largest share; i.e. 49% in 2010. Clinical Research Organizations (CRO) and Healthcare providers contributes 46% and 5% respectively in 2010.

Based on the mode of delivery, the global market is divided into three types; i.e. web-based, on-Premise and cloud-based. Among all these segments, the web-based market is forecasted to witness the highest CAGR of 15.95% from 2011 to 2016 and is estimated to capture 75% share by 2016 from 70% share in 2010. On-premise and cloud-based (SAAS) CTMS contributes 28% and 2% respectively in 2010.

North America dominated the global market with around 62% share in 2010. The U.S. captures the largest market share of North America, and shows a remarkable growth opportunity. The second largest market, Europe, while growth in the Asia-Pacific region is also expected to take greater curves in the near future.

Scope of the Report

This Clinical Trial Management Systems market research report will enable strategic understanding of the following key segments of the market:

Global market, by end-users:

• Pharmaceutical/biopharmaceutical
• Clinical Research Organizations (CRO’s) read more
• Healthcare Providers (Academic institutions/universities, hospitals, and research institutions)

26 new drugs permitted for sale without trials in India

New Delhi: Notwithstanding strong warnings by the parliamentary standing committee on health, new drugs continue to be approved for marketing in the country without holding any clinical trials on Indian patients to test their safety and efficacy

Sources in the Health Ministry admit that as many as 26 new drug molecules have been approved since 2010 without testing them through drug trials on local populations.

While eight new drug molecules of biologicals and non biologicals were approved by the country`s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), last year, two have already been allowed for sale so far this year.www.icbiocro.com

Govt mulling 'structured regulatory regime' for AYUSH drugs

Government has considered setting up of a structured central regulatory regime for AYUSH drugs," AYUSH Minister Shripad Naik said in a written reply in Parliament.

He said that the current proposal is to have a vertical structure for AYUSH in the Central Drugs Standard Control Organisation (CDSCO).

"Procedural steps for setting up of this structure have been initiated, but the timeframe cannot be specified at this stage," he said.

The minister added that, presently, the Drugs and Cosmetics Act, 1940, and rules thereunder have exclusive provisions for AYUSH drugs, which are enforced by the state governments.

For regulating the practice of Ayurveda, Siddha, Unani and Homoeopathy (AYUSH) medicine, the government has established the Central Council of Indian Medicine and Central Council of Homoeopathy under the provisions of Indian Medicine Central Council Act, 1970, and the Homoeopathy Central Council Act, 1973, respectively, Naik said.

In another reply, the minister said that there are a total of 543 colleges of AYUSH currently functional in the country of which 281 are of Ayurveda, 191 of Homoeopathy, 44 of Unani, 18 of Naturopathy and nine of Siddha medicine.

"There are six states -- Manipur, Meghalaya, Mizoram, Nagaland, Sikkim and Tripura and four Union Territories -- Andaman and Nicobar Islands, Dadra and Nagar Haveli, Daman and Diu and Lakshadweep, where no AYUSH college has been established so far," he said.

The central government grants permission for the setting up of new Ayurveda, Siddha, Unani (ASU) and Homoeopathy Medical Colleges under the provisions of Section 13A of the Indian Medicine Central Council Act, 1970, and Section 12A of the Homoeopathy Central Council Act, 1973, respectively.

"There is no Central Act and Regulatory Central Council for Yoga and Naturopathy," he said.

Naik added that a total of 92 proposals have been received during 2015 from various institutions (private as well as government) in the various states/UTs for the opening of new Ayurveda, Siddha, Unani and Homoeopathy medical colleges of which 63 proposals are for Ayurveda colleges and 22 for Homoeopathy. 

Why CDSCO's scheme to crack down on fake drugs may not work

The pressure is building up on the Indian drug regulator to clampdown on the fake drugs that are inundating the Indian market. A desperate CDSCO has decided to restart an old scheme -- reward to any whistleblower who is instrumental in the seizure of counterfeit drugs and cosmetics.

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clinical trials on Cosmetics,Personal Care and OTC products to claim safety and efficacy of the product

In today’s highly competitive skincare and anti-aging market, clinical evidence that your product is safe and effective can mean the difference between getting noticed and getting lost in the shuffle.

 The pathway from initial concept to health claim development and product commercialization is a multi-step process involving product analysis and testing, the investigation of product claim potential. To help you develop and commercialize your cosmetic and skincare product,

we offer a wide range of scientific services including:

 To help you navigate the complex and ever-changing clinical framework and ensure that your product is properly positioned in the marketplace, we can assist in the design and implementation of a clinical strategy in. We will work with you to ensure product compliance with applicable regulations. Our start-to-finish approach addresses all aspects of the clinical process including clinical trials, product analytics. we should have good team conducts clinical studies from complex double-blind, placebo-controlled trials to straightforward bioavailability studies for cosmetic, cosmeceutical and personal care products. We work with clients to provide full solutions from base concept to publication and claim development. Who can assist us components of a trial such as subject recruitment, protocol development, diagnostic testing and manuscript writing.

  Investigation of Safety & Efficacy Companies wishing to develop a new cosmetic or personal care product, or investigate new formulations and delivery mechanisms, must ensure that the ingredients are safe and efficacious in humans when used as directed. Efficacy evidence is also extremely important for the substantiation of a product’s health or effectiveness claims. We help companies through this complex process by conducting scientific literature reviews of the published clinical literature and compiling the evidence in the form of a comprehensive report. Our nutritional scientists and regulatory affairs specialists are expertly trained and experienced in gathering, synthesizing and interpreting the scientific literature in a timely manner, and will work with you to generate a dossier of supporting evidence should this information ever be requested from regulatory bodies. Scientific Literature Reviews In order to investigate the safety, efficacy and health claim potential of your product, we will conduct systematic scientific literature review was conducted per medicinal ingredient. Human clinical research papers were evaluated to determine the safety and efficacy of each medicinal ingredient using the databases PubMED, Scholar’s Portal and Web of Knowledge. As well, a review of the Natural Health Products Directorate [NHPD] Ingredients Database and Compendium of Monographs was also conducted.

  Preparation of Marketing Collateral Material We provide custom scientific writing services to help you market and promote your product. Whether you require a consumer-friendly report on the health or functional properties of a specific ingredient, or a detailed product-specific summary of the supporting scientific evidence, our team of scientists will prepare any type of written document you require. 

CLINICAL TRIAL OF POLY HERBAL PRODUCT IN THE TREATMENT OF PAINFUL KNEE OSTEOARTHRITIS

ABSTRACT Background: Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease or osteoarthritis, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone.

Arthritis is inflammation of one or more of your joints. Pain, swelling and stiffness are the primary symptoms of arthritis. Any joint in the body may be affected by the disease, but it is particularly common in the knee. Knee arthritis can make it hard to do many everyday activities, such as walking or climbing stairs. It is a major cause of lost work time and a serious disability for many people.

 Objectives: The aim of the study is to evaluate the safety and efficacy of EASY CLIMB CAPSULES in Patients with Painful Knee Osteoarthritis. Conclusion: Fifty cases registered for the clinical trial of Easy Climb were given two capsules a day- before food for 120 days. The cases registered for this trial showed significant relief from the clinical symptoms of painful knee osteoarthritis, thus enabling them to lead a better life. This was only possible due to the synergistic effect of multiple phyto compounds in the herb on the individual symptoms, on observing the results of this study and properties of the constituent phyto compounds, it can be said that osteoarthritis was controlled by Easy Climb.

 Easy Climb is an excellent painful knee osteoarthritis management product.

CDSCO / CR Industry Developments:

• DCGI sets up committee to examine label claims of products sold as multi-vitamins
•  CDSCO's clarification regarding import & registration of cosmetics in addition to existing guidelines
•   Health ministry to upgrade manpower and drug testing infrastructure across country
•   Sub-committee on online pharmacy extends deadline till Oct 30 for comments & suggestions from stakeholders
• Trust you will find this information useful for various business development initiatives and leverage this for effective cross selling of opportunities across the Lifesciences segment. This report can be shared with your existing/ target clients.

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