Zaznacz stronę

Contract research organizations in Japan began their clinical research activities in the early 1990s; Since then, the company has continued to grow. According to the Japan CRO Association (JCROA), CROs in Japan generated total sales of about $645 million (71 billion yen) in 2005 and increased to about $872 million (96 billion yen) in 2007. The figure for 2011 is estimated to exceed $1.5 billion (120 billion yen) (Figure 2.3). A CRO is a person or organization (commercial, academic or otherwise) engaged by the Sponsor to perform one or more of the tasks and functions related to a sponsor`s trial. A Contract Research Organization (CRO) is a company that provides specialized research services on a contractual basis for the pharmaceutical, biotechnology and medical device sectors. CROs rely on highly qualified personnel who typically have a degree in life sciences (e.g., B pharmacy, biology). Key roles found in CROs include clinical research staff, project managers, clinical trial assistants, clinical operations managers, regulatory affairs managers, site contract managers, quality managers, data managers, biostatisticians and statistical programmers, among others. It is expected that scientific understanding will be fostered or that new conceptual ideas and inventions will be created. Although the actual results of the work are not known in advance, the results must always be published. The university sets up all kinds of research contracts with a variety of external organizations, including from 2016 [update], there has been a 15.5% increase in R&D spending from 2015 to 2020.

[11] The list of contract research organizations includes the following well-known companies worldwide: A contract research organization (CRO) supports the development of pharmaceuticals, biologics and medical devices on a contractual basis. Services include, but are not limited to, drug development, product development, process development, bioanalytical method development, preclinical studies, any phase of clinical trials, with the exception of clinical trial management and pharmacovigilance services. India is becoming a leading destination for CROs for various reasons, . B such as the acceptance of intellectual property rights and international guidelines, the presence of a huge population with different medical conditions, the availability of large hospitals with a huge patient load, trained and accessible human resources, and low operating costs. Research contracts are legally binding agreements that govern joint research between the university and external organizations, whether those organizations fund the research or participate in the conduct of the research itself. Research contracts contain the conditions under which the university and the external organisation must carry out specific research. Contract research organisations offer screening services that can be used to elucidate the potential secondary pharmacology of a compound, such as.B. Eurofins Panlabs. The initial screen is usually a binding test, which should be followed by a functional display in case of activity to determine whether the attachment event has functional consequences such as agonism or antagonism. Typically, for cost reasons, only key connections are profiled across the entire disk. A smaller sub-panel can be used to obtain an initial assessment of the promiscuity of a compound.

A compromise must be made between the size of the panel and the number of connections that can be filtered. For chemotypes without known off-target liabilities, there is no need to study a large number of compounds. In this case, a subrange that contains targets known to cause toxicity when disturbed may be selected. For chemotypes that have been shown to be active against some of the targets, it makes sense to define an even smaller panel to filter out more connections and get enough structure-activity (SAR) data for the series and activities in question. The International Council for harmonization of technical requirements for the registration of pharmaceutical products for human use, a 2015 Swiss NGO of pharmaceutical and other companies, defined a contract research organization (CRO) specifically related to clinical trial services as:[6]:10 „A person or organization (commercial, academic or otherwise) mandated by the sponsor, perform one or more of the tasks and functions related to a sponsor`s study. Different CROs may offer different services, but they are most often grouped according to where their contribution appears on the sponsor`s research schedule, as well as the primary function of the CRO: a contract research organization that provides clinical research (CRO) services to pharmaceutical, biotechnology and medical device companies. Services can range from drug discovery to commercialization, from pharmacovigilance to post-approval services. In clinical trials, a sponsor (the organization that wishes to study the safety and efficacy of a new treatment) hires an CRO on a project-to-project basis. CROs provide the expert advice, guidance and execution experience necessary to conduct clinical trials safely and efficiently, without the sponsor having to hire these full-time staff. While clinical research activities are increasingly conducted by pharmaceutical companies, CROs have also established themselves in Japan. Several national CROs, such as EPS, CMIC, Tokyo CRO, etc., have started their operations in Japan to address cultural barriers of language, race, etc. and meet the specific requirements of local regulators.

Staff turnover and weekend feature coverage can be a big deal for CROs. Some CROs have excellent employee retention, while others have high turnover with „senior” study technicians who have only two to three years of practical experience. With these high-turnover CROs, the contract scientist must be aware of the relative inexperience of most study staff and how this may affect the execution of the study. When qualifying a new laboratory, a thorough review of staff training materials and curricula vitae should be carried out in order to assess the experiences of those involved in the study. While experience itself is not a guarantee of success, study staff with experience are more likely to understand what can and cannot be done in a study, how to properly perform routine and complex study functions, and how to adequately deal with problems when they arise. .