Showing items tagged as Clinical management

  • Study Sites: Too Many Vendors, Too Little Time

    15 March, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.

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

    4 February, 2016 Paula Gray, Navigant & Sharon Kvistad, Navigant

    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. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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  • One Q & a Lotta A’s about SOPs for Research Sites

    2 February, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    “What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

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  • The Patient is Missing

    1 September, 2015 Amy Musolino, Program Director, New Service Development, Fisher Clinical Services

    Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.

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  • Change in Pharmaceutical Manufacture

    28 May, 2015 Peter Murray, Consultant

    Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

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  • Data Integrity Starts With User Access

    10 March, 2015 Jamie Colgin, Colgin Consulting

    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.

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  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

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

    23 October, 2014 Holly Deiaco-Smith, MS

    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. 

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  • FDA Issues New Q&A On Data Integrity

    2 September, 2014 Jamie Colgin, Colgin Consulting, Inc.

    Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us:

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  • Certification: Is It Worth the Hassle?

    12 August, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

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  • Quality’s Role in Drug Approvals

    12 June, 2014 by Theresa Allio, Ph.D.

    In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.

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  • MasterControl Demonstrating Quality Management Software at MD&M East and DIA

    12 June, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    June is the month for weddings and trade shows. Though we're not celebrating any nuptials, you’ll find MasterControl at MD&M East this week and at DIA the week of June 15.

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  • MasterControl 's Ken Peterson and Patricia Santos-Serrao Featured SQA Speakers

    1 April, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.

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  • Sound Risk-Based Decision Making in Process Validation

    13 March, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “

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  • Be SMART: 5 Critical Factors in CAPA

    4 March, 2014 by Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.

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  • What’s in Your Training Toolkit?

    29 January, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    14 November, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years.  For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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  • Three Common Issues Involving Clinical Trials

    24 October, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.

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  • Developing a Winning FDA Strategy for Clinical Drug Development

    8 October, 2013 Robert L. Kunka, Ph.D., The Kunka Group, Inc.

    The idea of interacting with the FDA is sometimes mysterious and unsettling for a pharmaceutical company. The average person finds it difficult to work with a large organization that they don’t understand. For example, large banks understand this and advertise themselves as the friendly bank that works to help “their neighbors” with buying a house. The FDA’s clients are pharmaceutical companies. Unlike banks, the FDA has significant leverage over the company because it is responsible for reviewing a company’s drug with the hope that FDA will approve it. While many companies are also large, there is no real leverage that the company has over the FDA. Thus, the company is at a distinct unsettling disadvantage. However, both parties have the common desire to market safe and effective drug products. Where the rubber hits the road is that the two parties need to agree on what is needed to demonstrate that the drug is safe and effective.

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  • Introduction to High Risk Software Automated Testing

    24 April, 2013 Brett Castano, Clinical Operations Manager, RealityCorp

    In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinica

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