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Nov 14, 2013

6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA


Cindy Fazzi

by 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).

This is in addition to the requirement that sponsors and CROs integrate CAPA (corrective action and preventative action) as a tool for ensuring patient safety and data integrity throughout the clinical trial.

While most companies have risk management and clinical CAPA processes, they’re not leveraging CAPA to strengthen risk management and vice versa. If your company is a sponsor or a CRO, how effective are your risk management and clinical CAPA processes? Are you using them to supplement each other?



Nov 12, 2013

FDA Inspections: Be Prepared to Ensure Quality and Compliance

Michael R. Hamrell

by Michael R. Hamrell, Ph.D., RAC, FRAPs, CCRA, RQAP-GCP, MORIAH Consultants

You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility.  Does this raise your anxiety level and that of your staff to near panic levels?  A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions.   Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit.  However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

Regardless of your motivation or fears, proper preparation is the key to doing well in a FDA inspection.  The good news is that routine clinical inspections, unlike GMP inspections, are usually pre-announced and scheduled.  The bad news is that without good practices and proper procedures in place, no amount of advanced notice will give you enough time to build in compliance.  There is just no substitute for a prospective, quality approach to clinical research.

The Food and Drug Administration each year conducts approximately 900-1,100 worldwide inspections of clinical investigators involved in investigational studies for drugs, medical devices and biologic products. These inspections are carried out under the agency’s Bioresearch Monitoring Program (BIMO), which is designed to assess the quality and integrity of data that are submitted to the FDA to support product approval applications and to examine the human subject protection aspects of the study. The BIMO program comprises randomly selected, routine, on-site inspections and data audits to monitor all aspects of the conduct and reporting of FDA-regulated research. On occasion, the FDA will conduct a directed inspection of a specific site or study to look for problems that may have already been identified. The BIMO program is a global initiative and focuses on data collected at sites worldwide.  On the rare occasions that the inspection of a clinical study uncovers evidence of fraud or misconduct, the FDA must decide how to discipline the investigator and how to deal with the suspect data.


Grid Analysis for Simplified Supplier Selection

Jennifer Stepniowski

by Jennifer Stepniowski, Communications Director, Pro QC International


The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable.  Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs.  Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

In addition to objective evaluation, using a grid analysis is an excellent opportunity to incorporate brainstorming to consider the importance of various factors that have an effect on the decision.  This step is particularly important to the outcome of the process.

The grid analysis itself becomes less useful when factors are weighted incorrectly or excluded altogether. For the tool to work, the quality of what goes in (information) will directly affect the quality of what comes out (supplier selection).



Avoiding the Silo Effect: The Importance of Communication in Clinical Trials



Rebecca York

by Rebecca York, Senior Clinical Research Associate, PPD

As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.

Each trial stakeholder owns separate responsibilities, described in federal regulation and international guidance (Figure 1). Per 21CFR 312.50, clients are responsible to “provide investigators with the information needed to conduct an investigation properly,” and to ensure that regulatory authorities and investigators are “informed of significant new adverse effects or risks” with regard to the investigational product. Likewise, investigators are responsible for notifying the clients of “any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug.” Investigators also must communicate regular study progress to IRBs and clients to ensure that an investigation is “conducted according to the signed investigator statement, the investigational plan and applicable regulations.” Finally, the monitor is responsible to liaise between the client and investigator by facilitating the distribution of information from the client to investigational sites, as well as communicating site concerns to the client (ICH CGP E6 5.18.4).



Nov 4, 2013

MasterControl Electronic Quality Management Software Solutions Benefit a Wide Range of Industries

For more than two decades MasterControl software has made it possible for hundreds of companies in an extensive array of industries across the globe to improve quality processes and get products to market more quickly. Companies doing business in regulatory environments in particular use MasterControl solutions to ensure sustained compliance and stay ahead of competitors.

Is your organization’s primary goal to get products to market as quickly as possible without jeopardizing compliance or quality? Without a software solution that is specifically designed to enhance quality, ensure sustained compliance, and maximize efficiency through the automation of business processes (such as document management/control, employee training, audits, product lifecycle, etc.) that objective is unattainable.  By combining a customizable application with the best practices we have derived from all the industries in which our customers inhabit, MasterControl has developed the ultimate electronic quality management system that can fit the needs of organizations of all sizes and scopes.