모든 FAQ 날짜 2022 2021 2020 2019 2018 카테고리 Clinical Development Landscape in Asia Pacific 3월 14, 2023 FAQ What are the benefits of a well-designed, robust preclinical development plan? Felicity Grzemski PhD DABT 더 읽기 12월 14, 2022 FAQ The FDA and Clinical Trials In America, the FDA (Food and Drug Administration) was established as a federal agency in 1906 with the Pure Food and Drug Act. 더 읽기 11월 16, 2022 FAQ Clinical Data Management: Past, Present and Future Clinical Data Management (CDM) is an integral part of clinical trials and enables clinical trial staff to extract valuable, accurate, high-quality data during the clinical trial process. 더 읽기 11월 11, 2022 FAQ Types of Clinical Data Management Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial. 더 읽기 10월 31, 2022 FAQ Contract Research Organisations and the Different Roles They Play A Contract Research Organisation (CRO) provides research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement. 더 읽기 10월 27, 2022 FAQ Contract Research Organisations: Market and Trends The Contract Research Organisation (CRO) industry is constantly changing and growing due to various key factors like a growing healthcare sector, research funds, a growing patient population worldw 더 읽기 10월 20, 2022 FAQ The Future of Contract Research Organisations Contact Research Organisations (CROs) have undergone many changes over the past few years, thanks to the COVID-19 pandemic and technological advances. 더 읽기 9월 30, 2022 FAQ Bioinformatics Bioinformatics is the scientific discipline that includes the use of computers to collect, store and analyse information relating to biological data. 더 읽기 9월 21, 2022 FAQ DNA and RNA DNA (Deoxyribonucleic Acid) is the genetic material found inside cells responsible for a living organism's development and function. 더 읽기 9월 12, 2022 FAQ Pharmacogenomics Pharmacogenomics is the study of how a person’s DNA responds to drugs. 더 읽기 8월 26, 2022 FAQ 생물안전성 세계보건기구(WHO)에 따르면: "생물안전성은 인간과 동식물의 생명과 건강에 대한 위험과 환경에 대한 관련 위험을 분석하고 관리하기 위한 전략적이고 통합된 접근 방식이다." 이는 각 부문 간에 연관성이 있으며 위험이 부문 내부 및 더 읽기 8월 22, 2022 FAQ Bioprospecting and Biopiracy Bioprospecting is the search for and the commercialisation of new products that have been sourced from nature. 더 읽기 7월 29, 2022 FAQ 인체자원은행과 생명공학 인체자원은행(Biobank)은 연구 목적으로 사용되는 혈액 검체, DNA, 조직 검체 및 종양 세포를 보관하는 보관 시설입니다. 인체자원은행은 시험자가 심각한 질병의 예방, 진단 및 치료를 개선하는 임상시험을 수행할 수 있도록 지원합니다. 더 읽기 4월 1, 2022 FAQ Clinical Trends of 2022 2022 marks the third year of the worldwide COVID-19 pandemic, which continues to fuel the transformation of the clinical trial and the research industry. 더 읽기 3월 2, 2022 FAQ What is the Driving Force Behind China’s Biotech Revolution? In 2011, China stated that its biomedicine industry was one of seven strategic priorities, and in its Five-Year Plan (2015-2020), the Chinese government mandated that the biotechnology sector should exceed 4% of GDP (Gross Domestic Product) by 2020 in market size. 더 읽기 2월 7, 2022 FAQ Clinical Development Strategies for Western Biotech Companies in China Since 2015, the medical and research industries in China have seen a huge shift with their regulatory processes and framework, which is helping to pave the way for Western biotechnology companies t 더 읽기 10월 29, 2021 FAQ Virtual Clinical Trials in Asia and Australia The COVID-19 pandemic has had an impact on clinical trials around the world with the research and medical industry having to adapt to the ongoing challenges. 더 읽기 10월 18, 2021 FAQ Monitoring Participants in a Virtual Clinical Trial Monitoring is a crucial element of any clinical trial, with The National 더 읽기 10월 18, 2021 FAQ The Challenges and Opportunities of Virtual Clinical Trials Virtual Clinical Trials (also known as Decentralised Trials and Siteless Trials) bring clinical trials directly into the participant’s home via a central and virtual coordinating site. 더 읽기 10월 8, 2021 FAQ What is an Investigator Site File (ISF)? An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines. 더 읽기 10월 8, 2021 FAQ Corrective and Preventive Action CAPA (Corrective and Preventive Action) is a quality system plan which aims to resolve compliance issues and to prevent any further recurrences. 더 읽기 8월 13, 2021 FAQ Data Monitoring Committee Data Monitoring Committees (DMCs) also known as Data Safety Monitoring Boards (DSMBs) and Data Monitoring and Ethics Committee (DMEC) play a vital role in the safety of clinical trials and also enhance the validity and integrity of the results collected from trials. 더 읽기 8월 13, 2021 FAQ Reporting Serious Breaches in Clinical Trials A ‘Serious Breach’ is defined as being a breach of Good Clinical Practice or clinical trial protocol which has an impact on the safety or rights of a clinical trial participant, and the reliability 더 읽기 7월 28, 2021 FAQ What is an Investigator’s Brochure? An Investigator’s Brochure is a collection of clinical and non-clinical data about the investigational products that are the focus of the study. 더 읽기 7월 28, 2021 FAQ Randomisation in Clinical Trials The Use of Randomisation in Clinical Trials Randomisation Controlled Trials (RCT) is the process of randomly assigning participants to groups that receive different treatments, which ens 더 읽기 6월 10, 2021 FAQ What is a Trial Master File? (TMF) A Trial Master File (TMF) is a compilation of documents that prove that the clinical trial has been conducted following regulatory requirements (including Good Clinical Practice). 더 읽기 6월 3, 2021 FAQ What is a Case Report Form? A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each particip 더 읽기 4월 30, 2021 FAQ Data Management in Clinical Trials Clinical Data Management (CDM) is the process of putting together, handling, collecting and analysis of clinical data, which is done in accordance with regulatory requirements. 더 읽기 3월 29, 2021 FAQ The importance of control groups in clinical trials A control group refers to a group of clinical trial participants who do not receive the drug or treatment being studied in the trial but instead receive standard of care or a placebo. 더 읽기 3월 24, 2021 FAQ What makes a Good Clinical Trial Site The site selection is crucial to the outcome of a clinical trial; it has the power to either make or break it. 더 읽기 3월 17, 2021 FAQ Good Clinical Practices Good Clinical Practice (GCP) is defined as being an “internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.” 더 읽기 2월 25, 2021 FAQ How to Recruit Participants and How Participants can Take Part One of the most important and challenging parts of a clinical trial is finding participants who are willing to volunteer to test out a new treatment. 더 읽기 2월 18, 2021 FAQ Placebos: Why They Play an Important Role in Clinical Trials Placebos are used to form a comparison point for new treatments, so the medication being tested can be deemed safe and effective. 더 읽기 1월 15, 2021 FAQ Benefits of running clinical trials in Australia Australia has the reputation of being home to a world-class research infrastructure with renowned health professionals and researchers overseeing clinical trials. 더 읽기 12월 14, 2020 FAQ Glossary of Important Terms Related to Clinical Trials The following list are common terms that are often associated with clinical research and trials. 더 읽기 9월 10, 2020 FAQ Ensuring clinical trial participant safety The safety of clinical trial participants is of paramount importance to CRO companies. 더 읽기 9월 9, 2020 FAQ How to Understand the Structure of CRO Companies CRO (Contract Research Organization) companies can vary in size from global companies to small specialized groups. 더 읽기 7월 29, 2020 FAQ How CRO Companies Work? - A Basic Overview It’s quite common for pharmaceutical and biotechnology companies introducing new drugs and treatment to outsource trials of new medication or procedures to CRO Companies. 더 읽기 7월 29, 2020 FAQ How Long It Take a CRO Company to Complete a Clinical Trial? Before any new medication or treatment can be administered to patients, it needs to undergo several clinical trial Phases which test the treatment for effectiveness and safety. Clinical trials conducted by clinical research organization companies can take on an average six.. 더 읽기 7월 29, 2020 FAQ How to choose a CRO Company for Clinical Research? Selecting a reliable CRO clinical Research Company is crucial to the success of a clinical trial and pharma companies need to ensure they choose the right CRO Company to monitor and manage a project so it leads to a successful outcome. 더 읽기 Load More
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