Clinical Monitoring Featured Articles
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Source Data Verification: A Quality Control Measure in Clinical Trials
8/3/2015
In an industry that seems to be focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of source data verification (SDV) performed in studies—the process of cross-referencing data recorded in a case-report form to the original source information—is an integral part of risk-based monitoring (RBM) strategies. Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification. After all, why verify data that we already know to be correct, and is a low risk to the study as well?
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Risk-Based Monitoring: Understanding The Future Of Clinical Trial Monitoring
7/29/2015
While risk-based monitoring (RBM) has been a popular discussion topic among the clinical research community for quite some time, sponsors and researchers have been slow to implement adaptive strategies. RBM moves away from the traditional approach of frequent on-site visits and 100 percent source data verification (SDV) toward a combination of activities, including centralized data collection and monitoring.
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New EU Regulation Set To Drive Clinical Trial Harmonization
7/28/2015
Sponsor companies conducting clinical trials in the European Union (EU) are currently regulated by EU Directive 2001/20/EC, which provides guidance on clinical trial applications and conduct. Unfortunately, Directives always have to be transposed into National law. By transposing, different countries interpret Directives in slightly different ways. Every country has its own national legislation, resulting in different submission requirements, timelines, classifications, and safety reporting. The result of this lack of harmonization is a complicated and expensive trial process.
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How One Bio Company Tackled Its Data Visualization Challenge
7/16/2015
Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.
While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.
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Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs
7/14/2015
The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist. Business models for designing and implementing clinical trials require that multiple stakeholder organizations (e.g. pharma/biotech, CROs, co-development partners, and regulators) align on and successfully implement to mutually agreed quality expectations.
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Centralized Monitoring: A Smart Solution For “Oversight”
7/10/2015
As clinical trial management costs rise because of increasingly complex protocols and stringent regulatory requirements, it has become important to have proper oversight of clinical trials, programs, or projects to avoid any major setbacks and to ensure the achievement of required quality, expected timelines, and return of investment (ROI). Centralized monitoring, if customized and planned properly using the right technology, offers a smart solution for “oversight” of a trial/ program to ensure compliance to protocol and regulatory requirements and to control, mitigate risk/issue(s) on time.
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RBM Implementation: Developing An Effective Risk Based Monitoring Plan
4/22/2015
Risk assessment and risk management are two key aspects of Risk-Based Monitoring (RBM) implementation. RBM is about taking a holistic approach to assess all possible risks related to your study/program and then having a proper plan for risk management which includes systematic monitoring and controlling/mitigating risks throughout the conduct of a study/ program.
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Taking The “Risk” Out Of Risk-Based Monitoring
12/19/2014
The clinical trial landscape is continually evolving and with it, efforts in the improvement of participant safety and data integrity. CROs are beginning to transition from on-site monitoring, with 100% point-to-point source data verification, toward a risk-based monitoring (RBM) approach that utilizes source data review and more centralized monitoring techniques better adapted for mitigating risk.
While RBM has gained considerable attention in recent years, reluctance still remains around the approach—from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes.
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Are You ASKING For An FDA Warning Letter?
7/15/2014
Quality agreements, the contracts signed between drug sponsors and contractors, continue to be an object of interest for the FDA. The agreements are intended to define and explain the roles and responsibilities of parties involved in the making and handling of drugs and drug products. By stating who is responsible for what, they not only ensure regulatory compliance, but define responsibilities in the event of an adverse outcome. With the number of FDA 483s (Notice of Inspectional Observations) and warning letters on the rise, it is more important than ever for companies to not only have a quality agreement in place, but to make sure both sides adhere to its provisions.
In this article attorney Alan Minsk explains why there has been an increase in warning letters issued over the last few years, why you MUST have a quality agreement in place, and the three quality issues you must always be aware of if you want to avoid getting one.
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The Future Of Clinical Trials
3/27/2014
Timothy S. Krupa, MS, MBA, is currently president of TSK Clinical Development, LLC, a consulting firm providing leadership guidance and solutions in the clinical development space. Specifically, Krupa consults on clinical planning, clinical project management, clinical operations, and strategic partnering for the biotech and pharmaceutical industries. Tim recently took some time from his consulting practice to share his perceptions on outsourcing and strategic partnering in the clinical space.