Success Through Punctuality: How Adhering to Timelines Secures Funding for Clinical Trials
In clinical research, milestones like study initiation, patient recruitment, or the completion of data analysis are closely tied to investor payments. Funding for the next phase is only released once a milestone is achieved. This structure provides clarity but also places significant pressure on all stakeholders. Delays can have immediate and severe consequences: the following […]
Milestones Achieved: PEI Approval and First Participant Dosed in TGD001 Phase 1 Study
At SCIRENT, we are excited to work for TargED Biopharmaceuticals B.V. in developing TGD001, an innovative thrombolytic therapy for thrombotic diseases. PEI Approval in Record Time In October 2024, TargED Biopharmaceuticals B.V. received approval from the Paul-Ehrlich-Institut (PEI) for a First-in-Human study in Germany. This approval was granted in just 58 days, showcasing the importance […]
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.
