Copyright © 2023 KLCRO, All rights reserved.
Menu
Menu
In order to assess results based on possible trial designs, KLCRO provides optimal disease simulation and modelling. In a similar vein, we can evaluate and rank protocols before offering suggestions for improving particular facets of protocol design to guarantee appropriate data gathering and workable recruitment.
Additionally, data can guide patient-centric research tactics in the same way that it guides improved trial design. KLCRO uses a variety of globally recognised and de-identified patient datasets, not limited to just one, in order to maximise enrollment and facilitate practical feasibility assessments.
The medical device industry is technical, requiring a group of professionals who can handle regulatory complexity. At KLCRO, we understand how important it is to provide clinical trial and strategic support, particularly for novel diagnostic devices and indications. As a result, our medical device team offers a range of services, from simple sample collection of normal and healthy subjects to careful execution of MDMC/ Ministry of Health.
In order to conduct integrated digitalized and patient safety oriented clinical research studies and gather information and support, KLCRO also interacts with stakeholders, the medical device division of DRAP/Global Regulatory bodies, and national and international medical device associations. This allows clients to have confidence in the outcome of their trials and regulatory approvals.
While thoughtful study design can expedite day-to-day trial execution, it can also ensure you’re prepared for regulatory milestones and market access and positioning.
Building continuity in data across the development life cycle can simplify regulatory submissions. Meanwhile, outcomes and economics experts can work during your trial to determine the best way to position your product for payers.
Finally KLCRO commitment to working directly with patients, caregivers, investigators and advocacy groups can provide a real-world perspective to everything from protocol design to commercial positioning.
At KLCRO, we’re thinking ahead to guide more holistic product development programs for the benefit of patients and product developers alike.