Biotech FAQs Date 2023 2022 2021 2020 2019 2018 Category Asia Pacific Landscape Cell and Gene Therapy Clinical Development Landscape in Asia Pacific Data Management DCT/ Virtual Clinical Trials Early Phase Europe/ EastHORN Global Rare Disease Regulatory/ DDC/ FDA September 13, 2023 FAQ Rare Disease Clinical Trials: Unveiling Insights and Charting Progress A rare disease, as defined by the WHO, is one that affects fewer than one person in every 1,000 and is typically deadly. Read More September 13, 2023 FAQ Unlocking the Future of Healthcare: Exploring Global Clinical Trends in Cell & Gene Therapy Cell and gene therapy (CGT) is one of the most advanced areas of medicine that can effectively transform our own bodies into disease-fighting agents. Read More September 1, 2023 FAQ Nasopharyngeal Carcinoma: Unveiling Facts, Statistics, and Clinical Research Developments NPC originates in the nasopharynx, the upper part of the throat, just behind the nose and is primarily found primarily in Asian and African populations. Read More August 28, 2023 FAQ Advancing Treatment of Gallbladder Cancer (GBC): Clinical Trials, New Drugs, and Innovative Strategies GBC presents unique challenges due to its often-advanced stage at diagnosis. Read More August 24, 2023 FAQ An In-Depth Analysis of CRO Operations and Impact on Drug Development What does a CRO do? CROs are recognized as strategic partners for sponsors seeking to manage and conduct clinical trials efficiently. Read More August 10, 2023 FAQ The Future of Clinical Trials: Embracing Virtualization, Real-World Evidence, and AI Integration The clinical trial landscape is constantly evolving. Read More July 26, 2023 FAQ Navigating the evolving pathways to FDA approval In the last decade alone, the cost of developing a pharmaceutical asset has nearly doubled. Read More June 13, 2023 FAQ Location considerations for successful clinical trials In recent years, the Asia Pacific (APAC) region has emerged in the global clinical trial landscape as a leading destination for early to late phase clinical trials, with China at the forefront of t Read More June 13, 2023 FAQ Antibody Drug Conjugates & the Global Research Landscape Antibody drug conjugates (ADCs) have emerged as a promising class of targeted cancer therapies in recent years. Read More May 17, 2023 FAQ The Globalizing Clinical Research: The Advantages of Including Europe and Asia Pacific Regions The global market for pharmaceuticals is expected to reach over $1 trillion by 2024, driven by an aging population and the increasing prevalence of chronic diseases. Read More May 17, 2023 FAQ Going Global: How Working with a CRO Can Benefit Your Clinical Trials Clinical trials are an essential part of the drug development process. Read More April 3, 2023 FAQ The Cell & Gene Therapy Clinical Trials Global Landscape Cell & gene therapies have emerged as revolutionary treatments for a variety of diseases, including cancer, genetic disorders, and autoimmune conditions. Read More March 14, 2023 FAQ What are the benefits of a well-designed, robust preclinical development plan? Felicity Grzemski PhD DABT Read More December 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. Read More November 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. Read More November 11, 2022 FAQ Types of Clinical Data Management Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial. Read More October 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. Read More October 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 Read More October 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. Read More September 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. Read More September 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. Read More September 12, 2022 FAQ Pharmacogenomics Pharmacogenomics is the study of how a person’s DNA responds to drugs. Read More August 26, 2022 FAQ Biosafety According to the World Health Organisation (WHO): “Biosafety is a strategic and integrated approach to analysing and managing rel Read More August 22, 2022 FAQ Bioprospecting and Biopiracy Bioprospecting is the search for and the commercialisation of new products that have been sourced from nature. Read More July 29, 2022 FAQ Biobanks and Biotechnology Biobanks are storage facilities that house blood samples, DNA, tissue samples and tumour cells that are used for research purposes. Read More April 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. Read More March 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. Read More February 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 Read More October 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. Read More October 18, 2021 FAQ Monitoring Participants in a Virtual Clinical Trial Monitoring is a crucial element of any clinical trial, with The National Read More October 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. Read More October 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. Read More October 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. Read More August 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. Read More August 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 Read More July 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. Read More July 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 Read More June 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). Read More June 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 Read More April 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. Read More March 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. Read More March 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. Read More March 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.” Read More February 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. Read More February 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. Read More January 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. Read More December 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. Read More September 10, 2020 FAQ Ensuring clinical trial participant safety The safety of clinical trial participants is of paramount importance to CRO companies. Read More September 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. Read More July 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. Read More July 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.. Read More July 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. Read More Load More
