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.
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 […]
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 […]
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 feasibilitystudy for the JuxtaFlow Renal Assist Device (RAD). Insertion of the proprietary JuxtaFlowcatheters was overseen by […]
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 […]
Global medical technology and innovation company, LivaNova PLC, conducts the large medical device study ANTHEM-HFrEF to evaluate whether autonomic regulation therapy will benefit patients with symptomatic heart failure and reduced ejection fraction. The trial is performed by the US-based CRO CCSF, with SCIRENT responsible for managing the European sites. The prospective, international, randomized, controlled clinical […]
Drug developer Berlin Cures has launched a phase IIa trial for its β1-adrenoceptor autoantibody (β1-AAb) neutralizing ssDNA product BC 007.
The global COVID-19 pandemic has largely impacted the healthcare system and also the conduct of clinical trials. Many sponsors have had to adapt clinical trial operations to the changing conditions of the pandemic, causing major disruptions in trial conduct. Some trials have had to face the shutdown of trial sites, limited access to regulatory bodies, […]