clinical trial Articles
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Aramis Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial Evaluating A197 for the Treatment of Dry Eye Disease
Aramis Biosciences announced that the first patient has been dosed in its phase 2 proof of concept clinical trial evaluating A197, a novel, first-in-class, topical immunomodulatory agent for the treatment of dry eye disease. “This is an important milestone for Aramis Biosciences and a hopeful moment for dry eye patients given the suboptimal efficacy and tolerability limitations commonly ...
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What makes decentralisation the future of clinical trials?
With the emergence of COVID-19, Decentralisation of Clinical Trials became necessary to comply with social distancing requirements while carrying out clinical research. Over the past few years, the clinical trial landscape has shifted its focus to patient-centric practices to promote patient engagement. But now as the pandemic is long gone, it is time to reflect on how DCT studies are genuinely ...
By Clinion
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Indication prioritization for a CCR6 inhibitor In collaboration with big pharma - Case Study
The Challenge: With a drug in pre-clinical stage, our client was looking for the first indication to go into clinical ...
By CytoReason
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Summary of new EU Clinical Trial Regulation
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 the new regulation Insights on timing The ...
By DDi LLC
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The Benefits of Decentralized Clinical Trials for Neurology
The COVID-19 pandemic has catalyzed the implementation of decentralized clinical trials in neurology, bringing the immense benefits of clinical trials to light. This industry-wide push towards trial decentralization has emerged as a key element for improving clinical trial efficiency and improving the experience for patients and physicians. By utilizing digital technologies, such as wearables, ...
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Digital Endpoints in Clinical Trials for Neurology: Benefits and Impediments to Adoption
In addition to the pandemic, the digitization of healthcare is rapidly shifting clinical trials from analog to hybrid or fully decentralized clinical trials, catalyzing the development and implementation of digital health technologies to support clinical research. Digital endpoints not only support the decentralization of clinical trials but also provide a means to collect more sensitive, ...
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Effective patent life in pharmaceuticals
Effective patent life is lost in pharmaceuticals because of the lengthy time periods required for clinical trials and regulatory approval. A 1984 US law restores some of this lost patent time, while also facilitating generic competition when patents expire. This paper examines this law and the effects of other policy developments on market exclusivity times in pharmaceuticals. It also performs ...
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First patient inclusion of the METAglut1 study
The METAglut1 study is a prospective study to validate the diagnostic performance of the METAglut1 test in patients clinically compatible with GLUT1 Glucose Deficiency Syndrome (GLUT1-DS) or « DE VIVO Disease ».It will be conducted in about 40 French centers and plans to include between 2500 and 3000 patients over a period of 30 months. This study has received the support of the ...
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What Clinical Trial Speed Factors Can Sponsors Actually Control?
When promising drug candidates are identified for further investigation in clinical trials, sponsor companies are usually optimistic about outcomes. But there are times, when after years of sunk effort and resources, clinical trials fail to bring a viable drug to market. Frequently, a drug fails for safety or efficacy reasons that are beyond a sponsor’s control. However, to some degree, ...
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Origin applies to China regulatory agency for clinical pathway classification
Origin, Inc., a Phase III clinical-stage biotechnology company, today announced that it had applied to NMPA (formerly CFDA) for classification of its plasma-generated nitric oxide device for the purposes of conducting clinical trials in Hong Kong and mainland China, and that NMPA had accepted its submission. A determination is expected within sixty business days. Origin is in preliminary ...
By Origin, Inc
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Taking Medical Coding to the next level with AI and Machine Learning
Accuracy in medical coding is a vital aspect in aiding clinical trial operation success. It has presented an excellent opportunity for medical coders, working hand-in-hand with AI-enhanced computer-assisted coding systems, to quickly identify and validate the correct codes. Using natural language processing (NLP) and advanced Machine Learning algorithms, AI is transforming medical coding by ...
By Clinion
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Deliver Clinical Trials On Time and Within Budget By Addressing this One Problem
Annual planning is an opportunity to fix this long-standing clinical operations issue At the beginning of many pharma companies’ financial year, an annual planning process occurs. This presents an opportunity for stakeholders to align on short-, mid-, and long-term goals. Clinical stage pharma companies focus on clinical-trial related goals. These include completing ongoing clinical ...
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Rational Vaccines Announces a Clinical Trial to Determine Baseline Characteristics of Patients Diagnosed With Recurrent Symptomatic Herpes Simplex Type 2 (HSV-2) Virus
Study to be conducted at two leading research institutions in the U.K. Results will inform protocol design of Phase 1/2 clinical trial of Company's lead HSV-2 therapeutic vaccine candidate WOBURN, Mass. and OXFORD, England, Aug. 15, 2022 /PRNewswire/ -- Rational Vaccines, a company focused on revolutionizing the treatment and prevention of herpes to eradicate the disease, today announced the ...
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Essential Clinical Trial Systems for Small, Midsize, and Large Pharma
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
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A Bayesian design for phase I cancer therapeutic vaccine trials
Abstract Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not ...
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Focus On These 4 Things to Accelerate Clin Ops Productivity
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 ...
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How eCOA Improves Patient Experience and Data Quality
With the rising demand for improving patient safety in clinical trials, the adoption of patient-centric solutions is considered the best route to enhance data accuracy and experience automated workflows. This is where eCOA comes into play. In this blog post, we will find out how electronic clinical outcome assessments are helping the clinical trials industry handle the ever-growing list of ...
By Clinion
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hVIVO used Nuvonis’ GMP Vero cells to produce Novel SARS-CoV-2 virus for a human challenge model
One of the main benefits of using Nuvonis’ fully tested GMP Vero cells is the unparalleled speed towards clinical trials. A case example from one of our customers, hVIVO: First contact with Nuvonis in July 2020, due diligence, contracting, provision of GMP Vero cells and protocols, as well as full documentation Production of GMP material in November 2020 ...
By Nuvonis
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Evolving relations between the pharmaceutical industry and public sector research
The interface between the pharmaceutical industry and public sector research (PSR) is increasingly diverse, dynamic and complex. As the industry consolidates at the top end, it is also differentiating and fragmenting. A new layer of small focused-activity companies are emerging, many from PSR. This paper examines patterns of knowledge exchange between PSR and industry along the length of the ...
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Immunostimulants in the prevention of respiratory infections
Immunomodulation promises to be an effective prophylactic and therapeutic modality for chronic and recurrent respiratory infections. As opposed to vaccines, the term Immunostimulant (IS) refers to a compound that produces a state of non-specific immunity. Most IS are oral formulations of bacterial lysates that have been used in clinical practice for decades. One of the main obstacles in the ...
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