UL provides comprehensive services to support medical manufacturers with global regulatory approvals.
UL uses research and standards to continually advance and meet ever-evolving safety needs. Our Life & Health business provides comprehensive services, including CRO, to support medical manufacturers with global regulatory approvals.
Global reach – Our CRO team has direct contacts in several study sites around the world. Our team members speak several languages which helps build relationships, trust and enhances communications.
Local anchoring –Our CRO staff is located in multiple countries, minimizing travel costs for on-site activities and allowing the local site to interact with the team member in the local time zone and language. In addition, UL has offices around the world that can augment the CRO services with additional support as needed.
Flexibility – Our team is fully prepared to take on one or more tasks related to making your clinical investigation a success. We can be an extension of your staff so you can focus on other business needs.
Focus – Our team is dedicated to serving medical device companies and supporting the unique needs of the medical device clinical investigations and regulatory nuances. Having this focus has allowed our team to gain specific experience and knowledge in several therapeutic areas.
Dedicated Project Management – Each clinical project has its own project manager, specifically experienced in the therapeutic area and discipline.
Customer Service – We know the clinical investigations are extremely important to you, your employees and your business. Our team will work with you closely every step of the way.
Market Entry Alignment: Since EU tends to be the first location devices are launched, working with a team based in Germany, the largest EU country for medical devices is the logical choice for your clinical investigation.
We can be your clinical partner for the entire project or one or more areas of support:
The study design sets the stage for the rest of the investigation and can be one of the most important parts of the process. Our team has designed both relatively simple and complex studies to meet a variety of needs, including market approval, feasibility, pilot/pivotal and more.
Study Management / Monitoring
Our seasoned and knowledgeable clinical project managers work closely with our clinical monitors (CRAs) and sponsors to coordinate all study activities and help ensure your project is on schedule and on budget. We actively monitor the timelines and the compliance of the regulatory and normative provisions within the planned budget.
Our CRAs are on-site regularly and also verify that your clinical investigation is conducted in compliance with the provisions of the clinical investigation plan (GCP), ISO 14155 and the Declaration of Helsinki.
Our team is skilled and experienced in preparing the essential documents you need for the success of your clinical investigation. We can prepare your investigator’s brochure, clinical investigation plan, patient information & informed consent, the final clinical report and other documentation.
Depending on your needs and those of the regulatory bodies, we offer the classic paper-based CRF as well as an electronic form which complies with international standards (e.g., 21 CFR part 11). In advance of the statistical evaluation, the completeness and validity of your clinical data are verified and changed if necessary (query process and data cleaning).
Our statisticians are involved in your project at a very early phase to develop a suitable study design and determine the proper evaluation methods. The analysis of the acquired data is performed by experienced statisticians with validated statistics software.
Clinical Safety Management is an important aspect of any study. Our team can support the reporting and administrative work associated with adverse events (AE), clinical events committees (CECs) and data safety monitoring boards (DSMB).
Keep up to date with UL Solutions by signing up for your newsletter:
You have successfully signed up for our newsletter. You should receive a confirmation email shortly.