• The Globalization of Clinical Data in Medtech

    18 September, 2018 by Danielle Giroud, Founder and CEO, MD-Clinicals (Switzerland)

    Regulatory agencies are increasingly demanding prospective clinical data as part of the clinical evidence for medical device market access. That is increasing the costs borne by manufacturers. The silver lining: the acceptance of foreign data by those agencies, including China, is also on the rise.

    Full story
  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    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’s Top Clinical Pharma/Bio Trends to Date

    20 June, 2018 by James Jardine, Staff Writer, MasterControl

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

    Full story
  • A Force for Change: Millennials

    29 March, 2018 by Craig Morgan, Head of Marketing, goBalto

    A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.

    Full story
  • What Improv Comedy Can Teach Us About Communication in Clinical Trials

    1 March, 2018 by Beth Harper, President, Clinical Performance Partners

    A look at how some of the insights behind improv comedy training can help clinical trial teams develop and improve communication and problem-solving skills. It's no laughing matter.

    Full story
  • 3 Valuable Takeaways from the 2018 TMF U.S. Summit

    14 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Clinical professionals from around the U.S. gathered Jan. 16-18 at the TMF U.S. Summit 2018 in Orlando, Fla., to discuss current clinical study trends and some of the pressing issues relating to trial master file (TMF) management. Three underlying themes were prevalent throughout the 7th annual event.

    Full story
  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    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
  • Quality 4.0: Harnessing Technology to Enhance Traditional Quality Methods

    21 November, 2017 by Mike Rigert, Content Marketing Specialist, MasterControl

    Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.

    Full story
  • 5 Guidelines for Writing a Useful Clinical Monitoring Report

    15 November, 2017 by Brandy Chittester, IMARC Research, Inc.

    A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

    Full story
  • Anticipating Tensions Between Clinical Care and Study Protocol

    3 October, 2017 Laurie Meehan, Social Media Manager; Polaris Compliance Consultants, Inc.

    Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets? There’s a lot to consider.

    Full story
  • Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies

    3 May, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    In August 2011 the Food and Drug Administration (FDA) released a guidance entitled "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring," which highlights a new approach to clinical site monitoring different from that of years ago. In this most recent guidance, the FDA openly states that "Many sponsors have understood that FDA expects sponsors to conduct frequent on-site monitoring and 100% data verification for all trials," clarifying that this is not always the best approach or the most productive use of time.

    Full story
  • The Rising Costs of Clinical Trials

    31 January, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl

    One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.

    Full story
  • Regulatory Submissions: Filling the Critical Gaps in EDM Systems

    11 July, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and el

    Full story
  • Outsourcing Trends for 2012

    22 March, 2012 by Kate Hammeke

    With the goal of optimizing collaborations in the drug development industry, Nice Insight (http://niceinsight.com/) developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

    Full story
  • 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

    Full story
  • Good Clinical Practices and the Top Five GCP Violations in a Clinical Study

    18 April, 2017 Michelle Sceppa, Principal at MSceppa Consulting

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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).

    Full story
  • 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? 

    Full story