Learn how by embracing a systematic, data-driven approach, it is possible for metrics to identify more accurately the best sites, steps causing delays, the associated costs, and why this is happening.
Learn six strategies for success when developing your companion diagnostic.
In a recent New York Times article, Paula Span raises the concern that elderly subjects are frequently omitted from clinical trials. Consequently, physicians know very little about how a given treatment may affect their older patients. Is a medication effective for the elderly? Is it safe? Without data, how is a physician to know?
This article summarizes progress from the initial imaging biomarkers developed to evaluate tumor shrinkage in response to cancer therapeutics, to the challenges posed by contemporary treatment paradigms which may produce new patterns of response.
There is a significant need to collect Real World Evidence (RWE) to demonstrate the benefit of these drugs in clinical practice which can then be used as the wrap around to demonstrate true clinical benefit and address all stakeholder needs.
Current MRD detection landscape, key considerations for each approach, and current advancements that will contribute to further improvements in MRD detection.
This webinar provides an overview of the safety reporting requirements of the final rule and assess the areas that are likely to present the greatest compliance challenges.
A video overview of the valuable content that can be accessed as a DIA NOW user.
Learn about the application of immunoaffinity LC-MS to regulated bioanalysis of biotherapeutics.
Patient engagement solutions to expedite study recruitment.
Patient, industry, and regulatory stakeholders shared their perspectives on today's meaning of effective engagement and what the future state of patient engagement will look like. Panelists discussed what they believe should be the outcomes of their investments of effort and how we can engage patients to identify the outcomes that matter most.
In this DIAmond session, prominent thinkers on scientific evidence for support of biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE) for safety and efficacy questions and consider its uses for regulatory purposes. The benefits and challenges of using RWE to generate evidence of sufficient quality for decision-making, following the concept of using fit-for-purpose research tools, were examined.
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes.
The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval.
Learn how Q2 Solutions utilizes over 35 years of experience in infectious disease and immunology assay development and clinical diagnostic testing to provide you with solutions to meet your anti-infective and vaccine needs across the development continuum.