The many challenges sponsors face performing clinical trials led Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, to remark in 2017 that the clinical trial system is broken. But if that’s the case, how do we uncover the underlying problems and bring all stakeholders together to fix them?
Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.
The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.
In the first installment of this series, we explored payers’ increasing willingness to provide guidance on clinical trial design and pharma’s increasing desire to seek it. With billions of dollars potentially at stake for each party, there is growing awareness that pharma and payers cannot afford missteps in the drug development process. The traditional arm’s-length (or even adversarial) relationship between drug developers and payers is not ideal for both financial success and patient welfare.
Current MRD detection landscape, key considerations for each approach, and current advancements that will contribute to further improvements in MRD detection.
This white paper highlights the challenges of emerging and re-emerging infectious diseases such as TB, MSSA/MRSA, and Ebola.
Discover how a comprehensive personalized genomics strategy can help you identify the patients who would most likely benefit from a treatment and suffer the least side effects, ensuring the right drug is used in the right patient at the right time.
Learn what bioinformatics offers to precision medicine and immuno-oncology.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.
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What can you do during your study to maximize your chances of success when it comes time to submit?
As more and more sites adopt eSource, the industry is poised for swift change and dramatic growth.
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?
An overview of the PMDA innovative, fast-track regulatory initiatives including the sakigake Designation System and the most recent Conditional Early Approval System.