background image for GxP Lifeline
GxP Lifeline

Showing items tagged as Clinical management

  • 2021-bl-clinical-monitoring-reports_132x132

    How to Write a Useful Clinical Monitoring Report

    In clinical trials, site monitoring is required, but the report about the monitoring isn’t always given the attention it deserves. Prepare your next monitoring visit and the report by following these five tips to success.

    Full story
  • 2021-bl-gcp-violations_132x132

    Good Clinical Practices and 5 Common GCP Violations in Clinical Studies

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.

    Full story
  • 2020-bl-managing-compliance-costs_132x132

    CLIA Certification: 3 Things You Need to Know

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

    Full story
  • 2020-bl-thumb-well-controlled-clinical-trials

    How to Conduct a Well-Controlled Clinical Trial

    Successful clinical trials are a critical stage in the product life cycle of any life sciences product. Brandy Chittester, president of IMARC Research, outlines how manufacturers can conduct well-controlled trials that meet regulatory compliance and delineates pharmaceutical trials from those of the medical device industry.

    Full story
  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

    Full story
  • 2018-bl-thumb-how-minimize-protocol-deviations

    How to Minimize Protocol Deviations

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

    Full story
  • 2022-bl-gxp-lifeline-quality-4.0-oqsie_1200x628

    February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

    Full story
  • human-robot-ai-technology-132

    EU Policy 70 and Redaction — PleaseReview’s Take on It

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

    Full story
  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use.

    Full story
  • Data Integrity Starts With User Access

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

    Full story
  • From Good to Great – The One Skill Great CRAs Possess

    Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]