Celebrating Success: Imbria Pharmaceuticals’ Phase 2 IMPROVE-HCM Trial Results
Imbria Pharmaceuticals’ Phase 2 IMPROVE-HCM trial showed significant improvements in symptoms and exercise performance for nHCM patients. The Radcliffe Department of Medicine at Oxford University played a crucial role in this successful trial.
Echo Core Lab is a Key for Using Echocardiography in Clinical Trials
Echocardiography is an indispensable tool in clinical trials, providing detailed insights into cardiac function and structure without invasive procedures. Echo Core Labs enhance the precision and reliability of these measurements by standardizing procedures across multiple trial sites, significantly reducing variability and improving data quality. This critical role not only supports better clinical outcomes but also ensures the accuracy necessary for developing new medical treatments.
Navigating Change: Navigating a CRO Transition in Cardiovascular Research
In the rapidly evolving landscape of cardiovascular research, the strategic transition between Contract Research Organizations (CROs) is critical. This excerpt delves into the nuances of CRO transitions, highlighting the importance of meticulous planning, transparent communication, and the agility to adapt to new challenges. Understand the pivotal role that CROs play in advancing therapeutic innovations from concept to clinical reality, and explore the strategies that ensure these transitions strengthen, rather than hinder, the research continuum.
Integrating Phase 1 Studies in Healthy Volunteers and Patients with Cardiovascular Disease – A Comprehensive Approach
Phase 1 clinical studies are the initial step in drug development, designed to assess the safety and tolerability of a new molecule in humans. Traditionally investigational medicinal products (IMP) were tested in multiple Phase 1 clinical trials that enrolled large numbers of healthy participants before a first patient was randomized.
Site Management and Study Start-Up Enhancement: A Strategic Focus in Cardiovascular Research
Insights into best practices and efficiency improvement in clinical trials highlight the importance of thorough site identification and selection in the field of cardiovascular research. Managing the complex regulatory environment requires well-thought-out document management and early engagement with regulatory authorities. Technological solutions, such as electronic document management systems and cloud-based tools, play a crucial role […]
Maximizing Success in Cardiovascular Trials: The Advantage of Partnering with a Specialist CRO
The industry spent over $200 billion globally in 2021 on developing new therapies for treating cardiovascular diseases. However, it’s estimated that more than half of the investment in clinical development is wasted. Various factors contribute to this, including a lack of efficacy compared to approved competitors, poor trial execution, slow recruitment of the trial, lack […]
First patient enrolled in feasibility trial for JuxtaFlow® Renal Assist Device (RAD)
Roswell, Georgia – 9 October, 2023 – Roivios Ltd., a medical device company pioneering a revolutionary treatment to reduce poor surgical outcomes associated with Acute Kidney Injury (AKI), today announces the first patient has been enrolled in the BIPASS-AKI early feasibility study for the JuxtaFlow Renal Assist Device (RAD). Insertion of the proprietary JuxtaFlow catheters […]
Innovative Medical Device for Heart Failure Treatment Delivers Promising Results
Berlin Heals’ innovative implantable C-MIC device delivers encouraging clinical results in the treatment of heart failure.
Restarting by Design: Agile Crisis Management for Rapid Resumption of Cardiovascular Clinical Trials
The entire landscape of hospital-based clinical trials dramatically changed when COVID-19 singlehandedly stopped the global recruitment of ongoing cardiovascular trials. Heart failure clinical trials were already subject to factors such as regional variation in clinical practice, trial implementation, and patient characteristics, which drive event rate and treatment effect size assumptions key to demonstrating clinical benefit. […]
SCIRENT and Virtonomy Announce Joint Efforts to Advance Use of Virtual Patients in Medical Device Clinical Trials
SCIRENT, a full-service contract research organization (CRO) specialized in cardiovascular trials, and Virtonomy, a pioneer in developing data-driven clinical trials using virtual patients, announced today their cooperation on the use of virtual patients in medical device clinical trials. Both companies offer services for the development of medical devices. By working together, valuable time and financial resources […]
