We'll help you design, implement and manage the studies. Give us a call today at (978) 358-7307, or just click here:
The landscape of clinical studies is evolving. Today, designing and managing clinical studies must be driven by regulatory and insurance reimbursement requirements, rather than relying solely on traditional pharmaceutical models of clinical study design. This shift is especially critical in the medical device and combination product sectors, where outdated approaches can lead to costly missteps. For small to medium-sized companies, generating the necessary clinical evidence can represent a significant financial investment.
In the United States, the FDA may require clinical evidence as part of a 510(k) submission and mandates it for a Premarket Approval (PMA) application. In the European Union, clinical evidence is often essential during the CE marking process, particularly when existing data on safety and performance is insufficient.
The specific requirements and designs of clinical studies can vary significantly depending on the regulatory pathway and the purpose of the evidence being gathered. This variability underscores the importance of maintaining a clear focus on the ultimate objective of the study from the outset.
When developing a brand-new medical product aimed at treating a condition with no existing successful treatments, a classic phased approach to clinical studies is often the clear and necessary path. However, if your medical device or combination product incorporates a novel technology and the objective is to demonstrate that this technology maintains or improves therapeutic effectiveness, it is important not to force-fit your study design into the traditional Phase III pharmaceutical model.
At RQMIS, our consultants excel at crafting innovative protocol designs and investigational plans tailored to your product's specific needs. We adhere to Good Clinical Practices (GCP), FDA guidelines, and ISO 14155 standards while keeping the study's core objectives in sharp focus. With over twenty-five years of experience, we have successfully collaborated with clinicians and clients to design and manage studies across a wide spectrum—from small, focused fifty-patient studies demonstrating that a device modification has not impacted safety or performance, to large, multi-site international studies proving that a device with a new intended use can safely and effectively achieve its intended outcome.
Our approach emphasizes strategic, objective-driven study designs that align with regulatory expectations while avoiding unnecessary complexities or constraints from mismatched study models.
At RQMIS, we understand that startups often face significant challenges when it comes to conducting clinical trials or studies due to limited resources. To address this, we offer comprehensive support across all activities required to design, secure regulatory approval for, and manage clinical trials effectively. Additionally, we provide assistance with specific tasks related to clinical studies, including:
We also offer specialized bioresearch monitoring services, including independent audits of clinical studies to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and the highest standards of patient protection and data integrity.
Our bioresearch services include:
Partnering with RQMIS ensures that your clinical studies are conducted efficiently, meet regulatory requirements, and maintain the highest standards of quality and compliance.
We'll help you design, implement and manage the studies. Give us a call today at (978) 358-7307, or just click here: