ABOUT PRO-FICIENCY

Pro-ficiency's mission is to eliminate protocol deviations, one study at a time, by bringing simulation to clinical trials training. The simulation approach tackles the highest risk areas of the study protocol, enabling clinical research teams to exercise critical decision-making in a risk free environment, much like a flight simulator for pilots. Allowing the study teams to practice protocol implementation and potentially make mistakes in a simulated environment, protects the patient and the study integrity. The result is fewer deviations, better outcomes and rich behavioral data that can drive preventative action that can keep clinical studies on track and on budget.

FEATURED CONTENT

CONTACT INFORMATION

Pro-ficiency

4242 Six Forks Road, Suite 1519

Raleigh, NC 27609

UNITED STATES

Phone: 703-597-3014

Contact: Jenna Rouse

FEATURED ARTICLES

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

  • 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 those rising costs.

  • 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.

  • 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.

  • When it comes to decentralized clinical trials, explore why sponsors and research sites might need to do better in looking closely at their specific patient cohorts to determine what individuals in those groups truly need.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 in this article.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • The PhRMA Code is a voluntary code of ethics, relating to interactions pharmaceutical companies have with U.S. healthcare professionals. This code provides a collection of detailed rules, as well as broader principles, that have yet to be compiled into a comparable industry or government document.

  • Although it can be tricky to acquire proper clinical site training, inadequate planning for a research study’s training needs will create unnecessary, avoidable costs down the road. Let’s take a look at a not-so-uncommon scenario.

  • Over the last several years, the pharma industry has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines and in the clinical trial recruitment phase of new drug research and development. However, relatively little attention has gone to diversity within the clinical research workforce, which many industry insiders have suggested can significantly enhance study population diversity.

  • In this post, Beth Harper advocates having CRAs conduct site training at site initiation visits (SIVs).