Metrics Learning Institute

Mastering Risk Management

eLearning Courses – 301

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management [e301]

Recent updates included in ICH E6 (R2) section 5 (Quality Management) mean that the quality management methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected.

But … does your organization understand risk and how to implement risk management in your clinical research program?

You — like many sponsors and their partners — might have limited experience with using risk-based quality management approaches in clinical research.

Mastering Performance Metrics

Your clinical trial performance data can help save millions of dollars in improved processes — only if your people understand how to harness them.

Now there’s a way to help your key people master performance metrics and eliminate exorbitant inefficiencies…

… Introducing “Mastering Performance Metrics” eLearning Program

Metrics are the key to improving clinical research processes. But without an ability to translate the often overwhelming performance data stream, metrics are useless.

Only people can link the numbers to improved processes: “Mastering Performance Metrics” eLearning courses make that link possible.
“Mastering Performance Metrics” lets you unlock the power of your data to dramatically improve clinical research efficiency.

Metrics help you achieve more reliable research results, faster timelines and reduced costs.
Three “Mastering Performance Metrics” eLearning Courses help you build a team of metrics experts.

These courses use fast-paced audio, video and text to accommodate different learning styles — all on your own schedule. Your team members can choose to take one, two or all three courses, as appropriate. All three courses allow you to earn ACRP and SOCRA CE credits and prepare you for Metric Master Certification.

Elements that Make Metrics Effective

… gives every person on your team — from front-line staff to senior management — a foundation in clinical trial metrics. This ensures everyone is “speaking the same language” when deciding which data are most meaningful. It also helps the team understand how they can use data to assess clinical trial speed, costs and outcome quality.

Developing Effective Metrics Using a Structured Process

… helps managers identify the most critical metrics necessary to meet your company’s performance targets. The course shows you specifically how metrics are used in process analysis to identify opportunities for improvement, so as to accelerate trial completion, protect budgets and ensure consistent quality.

Effective Metric Visualizations to Gain Valuable Performance Insights

… helps managers communicate clinical trial operations metrics both to front-line staff and senior management so problems, obstacles and opportunities are presented clearly, understandably and impactfully. Your goal is present data such that it increases the likelihood that transformative actions will be taken to streamline processes.

Put your metrics skills to practical and profitable use through the Metric Master Certification Independent Project.

Certification helps mid- and senior-level managers solidify — through applied learning — skills acquired in the three previous courses.

By having learners work — with an expert metrics mentor — on a specific performance evaluation project, companies can use this certification process to refine the use of metrics to gain valuable insights about your clinical trial program.

Even better, using real-life metrics, this certificate project can be employed to evaluate, identify and implement specific process improvements.

Upon successful completion of the eCourses and Independent Project, you will be awarded a Metric Master Certificate and a Metric Master logo for you to add to your email address box. You may add this unique certification to your Resume, CV and LinkedIn Profiles.

“Mastering Performance Metrics” offers high-value return for a modest investment in professional development.

This program supports pharmaceutical firms and CROs with a commitment to continuous quality improvement—and controlling research costs.

Neglecting to identify Clinical trial performance failures—and the cause of such failures—can amount to hundreds of thousands, even millions, of dollars in direct costs and time-to-market opportunities. For a tiny fraction of these stakes, the “Mastering Performance Metrics” Program lets your team members acquire the skills necessary to analyze and dramatically improve your clinical research processes:

• Elements that Make Metrics Effective — $320
• Developing Effective Metrics Using a Structured Process — $320
• Effective Metric Visualizations to Gain Valuable Performance Insights — $320
• Metric Master Certification Independent Project — $320
• Metric Master Certification Program (includes eCourses 201, 202, 203, plus independent project) — $1,150

How our “Mastering Performance Metrics” education program helps your team learn actionable skills—faster and more flexibly.

Our courses provide you with a foundational understanding of why organizations measure performance and strengthen your ability to effectively use performance metrics. Our role-based eLearning training scenarios allow you to customize your experience by giving you the option to view Data Management, Study Oversight, Site Monitoring, and Investigator/Site Coordinator examples of key concepts described in the courses. You can take one course, a series of courses, or complete all the courses and an Independent Project to receive your Metric Master Certification.