Where do companies see the greatest difficulties in the different clinical study phases?
Munich, Tuesday, July 21, 2021. Munich-based software company Climedo Health and Curedatis are inviting companies to take part in a new survey on clinical studies in companies. This survey is aimed at medical device manufacturers and pharmaceutical companies, but contract research organizations (CROs), consultants, distributors, suppliers and end users are also invited to participate. The survey will run for approximately 30 days, and the aggregated results will be made available to participants upon request.
The aim of the survey is to analyze the challenges of clinical studies in the planning, implementation and close-out phases and also to distinguish between pre-market studies and post-market or observational studies. In addition, Climedo Health and Curedatis would like to explore the extent to which digital solutions are already being used in the different study phases and to find out what still needs to happen in this regard. Finally, the survey addresses both experiences with new types of studies (such as virtual studies) and specific wishes of the participants in the context of clinical studies.
The survey consists of 26 questions and addresses the following areas:
- Planning phase of clinical studies
- Implementation phase of clinical studies
- Close-out phase of clinical studies
- A look at the future
“Clinical studies are critical for medical progress. Yet, companies often struggle with insufficient resources, intransparent regulatory requirements and a lack of digital solutions,” says Veronika Schweighart, Co-Founder and COO of Climedo Health. “This results in low-quality research results. Our survey aims to get to the bottom of the challenges and to find out what companies need to overcome them. We look forward getting many responses and to publishing the results soon!”
Robert Radloff, Founder of Curedatis, comments: “Due to the increased requirements and complexity of the various regulations (EU MDR, IVDR, GDPR), the costs for generating clinical evidence are rising for medical device manufacturers, ‘DiGA’ (apps on prescription) manufacturers and diagnostics companies, as well as for physicians and patients. Maintaining competitiveness and safety for products requires digital, AI-powered tools as well as pragmatic approaches – from planning to study completion.”
Survey participants can request a copy of the full results to be emailed to them once the survey has been closed.
The survey is accessible here.
About Climedo Health
Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products. By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies – and ultimately – accelerated medical innovation.
Curedatis is a startup that digitalizes and automates the process of generating clinical evidence to help medical device, in vitro diagnostics, and digital health companies meet the requirements for sufficient clinical evidence under the MDR, IVDR, and DiGAV. Learn more: www.curedatis.com.