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Clinical Regulations Articles & Analysis
14 articles found
Medical advancement relies on clinical trials, which are essential for the development of safe and effective innovative treatments. However, the success and general applicability of these treatments heavily depend on the diversity of the participants involved¹?³. This blog explores the importance of achieving data diversity in clinical trials to enhance clinical trial results and ...
Therapeutic monoclonal antibodies (mAbs) are a class of antibody drugs that are highly uniform and have pharmacological effects against a single epitope obtained through molecular biology. In the process of new drug development, the study of pharmacokinetics is of great significance. The result can be used to guide the screening and development of drugs, and support the evaluation of their ...
In the past ten years, the number of antibody drug conjugates (ADCs) entering clinical trials has steadily increased. Currently, 9 ADCs have been approved, of which 5 are used for hematoma and 4 for solid tumor treatment. After more than 20 years of development, ADC biopharmaceuticals are becoming the main force in the treatment of cancer. Currently, one of the most important challenges when ...
The World Health Organization in its report on Neglected Tropical Diseases has stated that there is overwhelming evidence to show that the burden caused by many of the 17 diseases that affect more than 1 billion people worldwide can be effectively controlled and, in many cases, eliminated or even eradicated. Leishmaniasis caused by Leishmania spp is one such example and poses a grave health risk ...
The Clinical CRISPR Successes Are Stacking Up. But Where’s the Emphasis on Quality Control? In mid-September, Intellia released some promising data on two of their CRISPR-based therapeutics. These results are a significant milestone for genome editing and validation of its effectiveness in the clinic. However, the safety of CRISPR-based therapeutics has been a major concern and part of a ...
The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to do so in every changing regulatory environment where Clinical Trial and related data is being ever more scrutinized. This paper provides a synopsis of ...
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Whether you are a first-time user or an expert in NovoSorb BTM (Biodegradable Temporizing Matrix) for dermal repair and reconstruction, we’re here to answer questions you may have regarding its use in a clinical setting. Below is a list of questions we get asked the most regarding the use of NovoSorb BTM. 1. Can NovoSorb BTM Be Applied with a Graft in a One-Stage Procedure? NovoSorb BTM ...
A completely redesigned version, PhysioSensing Balance Software´21 was already released, after a long journey of new developments and software improvements. PhysioSensing Balance Software´21, after 10 years of development and experience, is now a powerful balance software analysis tool. We are updating it to all our clients. In this version, you can find: A newdesign, that allows ...
Whether your clinical operations team sits in a large sponsor company, or in one that’s still growing, it must be supported by efficient systems to maintain high productivity. Clinical trial protocols must be conducted with quality, within budget, and within timelines. To achieve this, Clinical Program Managers and their teams must be able to rely on 4 things: A strong ...
Childhood vaccinations provide immunity to children against serious infectious diseases before they are exposed to them to prevent illness. Many childhood diseases, such as smallpox and polio, have been almost completely eradicated as a result of widespread, standardized childhood vaccination programs. Some vaccinations, such as those for highly contagious diseases including measles, mumps, ...
Purpose To present the acceptance and the commissioning, to define the reference dose, and to prepare the reference data for a quality assessment (QA) program of an ultra-high dose rate (UHDR) electron device in order to validate it for preclinical animal FLASH radiotherapy (FLASH RT) experiments and for FLASH RT clinical human protocols. ...
A new study was published in March of 2021 demonstrating that elevated liver stiffness, as measured by magnetic resonance elastography (MRE), is associated with higher rates of cardiovascular disease in patients with non-alcoholic fatty liver disease (NAFLD). As clinical researchers, regulators and pharmaceutical partners pursue noninvasive biomarkers to replace ...
After a lightning round of proposals and reviews, an international team of scientists led by Dr. Camillo Ricordi was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. The therapy uses ...
The increasing demand for reduced cost and improved quality of service in healthcare has prompted the call for better management of medical knowledge. The main emphasis has been on knowledge that is acquired through experience and medical research and then formalised into Clinical Practice Guidelines (CPGs). This paper presents a generic approach to CPG information and knowledge management that ...