Bringing a new medical treatment to market is a challenging process - one that is not always fruitful. It is estimated that clinical development programs fail four times out of five. Although a clinical trial can fail for many reasons, poor trial design is often the main cause for failure.
The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
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If sponsors want to enroll and retain patients, they must take steps to mediate the information overload & falsehoods that their patients are exposed to and continue to establish trusting relationships with them. Using the correct guidance as a road map, sponsors can work to drive recruitment, enrollment and completion of their trials with more robust data at a lower cost and reach their goals of regulatory approval at a faster rate.
US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures.
The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.
The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has prioritized guidances for topics including Unique Device Identification, 510(k) premarket notification issues and voluntary consensus standards for its 2018 fiscal year.
Artificial intelligence researchers at Google claim they have used new software to more accurately predict hospital patient outcomes, including death, discharge and readmission, than is currently possible with existing software, according to a Quartz report.
Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise.