FEATURED ARTICLES

• Analyzing Protocol Deviations Before Retraining

  Determine what constitutes addressing protocol deviations properly and how to create a corrective and preventative action plan to avoid trial setbacks.

• Preemptive Protocol Analysis: Reducing the Need for Retraining

  Master the design of clinical protocol to develop a training program that anticipates potential practice deviations, meets the site’s needs and supports research staff.

• 3 Steps For Reducing Costs And Errors In Clinical Trials

  Read about the three simple steps can help clinical researchers reduce both errors and costs during studies.

• Bringing Protocols To Life To Reduce Site And Patient Burdens

  Discover why it is increasingly important that study sponsors make sure to get their protocols right from the start to avoid unwanted delays or cost overruns due to mistakes.

• Developing Protocols For Patient-Centricity

  Creating a research experience that addresses patient-expressed needs and wants is an important part of recruiting and retaining sufficient numbers of qualified patients.

• Embrace Innovation To Dodge Rising Trial Costs

  Discover the ways the clinical research industry needs to overcome its traditional resistance to change and adopt innovations that can save both money and time to mitigate the impact of rising costs.

• Reducing Study Team Burden With Shorter Training

  The time and energy needed for training is among the many drains that researchers complain about, and the one that clinical trial sponsors have the greatest control over.

• Selecting A Study-Specific Protocol Training Strategy

  When it comes to clinical protocol training, read why research sites and sponsors need to determine what their ultimate goals are to correctly identify the best training tools for the job.

• Decentralized Clinical Trials: Balancing Patient And Site Needs

  When it comes to decentralized clinical trials, explore why sponsors and research sites might need to look more closely at their specific patient cohorts when determining what individuals they truly need.

• Three Barriers Preventing Clinical Trial Innovation

  In this article, learn about the three deeply ingrained institutional barriers that appear to be at work when it comes to the clinical research industry moving towards innovative solutions.

• Reducing Study Team Burden With Targeted Training

  Explore how an approach to training that carefully targets site and individual weak areas, along with critical protocol procedures, could not only reduce deviations, but also play a key role in reducing overall burdens on research site personnel.

• Mitigating Study Risk With Performance Analytics

  Increasingly, both sponsors and research sites are turning to various types of performance metrics to support risk-based management of clinical trials. But collecting and analyzing performance data after a trial has begun may not be the best approach.

• Correcting Site Enrollment In 3 Steps

  In theory, sponsors should be picking sites that have known patients that fit a protocol’s inclusion/exclusion criteria. But that does not always happen for a variety of reasons. Find out why in the available article.

• Reducing Protocol Deviations With Training-Based Metrics

  Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. This article seeks to determine whether training in individual protocols is adequate, given the frequency with which deviations occur.

• Telling Ain't Training

  Whether to ensure GCP compliance or the correct application of a study protocol, training is a critical part of any clinical trial. Find out why.

• Preventing Protocol Deviations With Simulation-Based Training

  Protocol deviations can have a devastating impact on the quality and integrity of key study data and potentially affect patient safety. Taking the right approach when training investigators, research coordinators and other key staff can be critical to avoiding protocol deviations.

• The Fallacy Of Footnotes Within Clinical Protocols

  Discover how including footnotes is a common practice and one that contributes more to non-compliance than just about any other facet of the protocol.

• SIVs: Identify Skill Gaps Before Retraining

  Discover how a focus on evaluating protocol-specific training already conducted at a research site could hold a key to better focusing site initiation visits (SIVs) on critical factors and reducing the amount of time spent on these meetings.

• Maximizing Site Enrollment With Better Protocol Comprehension

  Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process -- the investigative sites that implement the trials and interact with the patients throughout the process.

• Behavior Should Drive Clinical Trial Training, Not Test Scores

  Applying analytics that focus heavily on measuring changes to research staff behavior during training can be a strong predictor of performance during an active clinical trial, leading to better protocol and GCP compliance. Learn how training is important to ensure that researchers conduct clinical trials in accordance with the research protocols.