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CluePoints to Share COVID-Informed RBQM Best Practice at #SCOPE2021

By February 12, 2021 February 21st, 2021 No Comments

It has never been more important for the clinical trial community to come together and share best practice – which is why CluePoints is delighted to be taking part in SCOPE 2021.

The Summit for Clinical Operations Executives, which will be held online between 2nd and 4th March, 2021, is an opportunity to drive innovation across the study lifecycle, from planning and design, to execution and reporting.

As well as hosting a virtual booth, where visitors will be able to learn about our industry-leading Risk-Based Quality Management (RBQM) Platform, CluePoints will give two presentations. Both of which will reflect on what we have learned from the COVID-19 crisis, and how to apply that knowledge to creating the safe, efficient, successful clinical trials of the future.

RBQM and the Pfizer Vaccine

CluePoints’ Chief Scientific Officer, Steve Young, and Nechama Katan, Pfizer’s Director, Data Science, will take to the virtual podium on Tuesday, March 2, 2021 at 10:15 am to talk about Risk-Based Quality Management and Centralized Monitoring.

RBQM/CM Implementation: Lessons from Pfizer’s COVID Vaccine Trial will explore how the study leveraged the methods to improve quality and proactively identify and address issues.

Due to the size and speed of the critical trial, the team were forced to innovate, developing fresh approaches to Risk-Based Quality Management and Central Monitoring. Young and Katan will share the processes and tools that were utilized, as well as the tips and tricks they used to ensure the whole team was engaged in what was to become one of the most hotly anticipated clinical trials in history.

Review of the Evidence

Young will give a second presentation during the summit on Tuesday, March 2, 2021 at 11:15am: Reviewing the impact of RBQM during COVID-19, he will talk about recent use cases and associated metrics, as well as the best practices associated with RBQM success.

Steve explains that the industry had been moving towards the adoption of RBQM – the process of identifying, assessing, monitoring, and mitigating the risks that could affect the quality or safety of a clinical trial – for some time. But the pandemic, he explained, had significantly accelerated adoption.

“When organizations found themselves in a race against time to develop and test vaccines and treatments to counter the global threat of SARS-CoV-2, they needed safer, more efficient approaches to clinical trials. RBQM has fulfilled that need.

“And this wider implementation has generated an ever-increasing body of evidence that confirms just how effective and valuable this new paradigm is,” said Young.

“As leaders in RBQM technology, CluePoints are delighted to be able to share the lessons from the last year with our colleagues and fellow clinical trial community members at SCOPE Virtual. By applying these learnings to the studies of the future, we can truly transform the way clinical trials are planned, designed, executed, and reported.”

What is the SCOPE Summit?

Now in its 12th year, the SCOPE Summit is a congress for clinical ops directors. This year’s event will take place entirely online.

“During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation,” said the SCOPE team.

“Over the course of three stimulating days of in-depth discussions in 23 different conferences, five plenary keynote sessions, the fifth annual Participant Engagement Awards, the new China Clinical Development Partnering event, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management and operations.”

As well as risk-based monitoring, the summit will cover topics including:

  • De-Centralized Trials
  • Site Selection and Management
  • Patient Engagement
  • Recruitment and Retention
  • Protocol Optimization
  • Feasibility
  • Telemedicine
  • Data Strategy and Analytics
  • Sensors and Wearables
  • Project Management
  • Outsourcing Forecasting
  • Budgeting and Contracting
  • Resource Management
  • Quality by Design (QbD) in Trial Conduct
  • Artificial Intelligence
  • Post-Marketing Studies
  • Observational Research
  • Accessing and Generating real world data
  • Clinical Biomarker Strategy
  • Clinical Supply Chain
  • Precision Medicine
  • Clinical Biomarkers and Biospecimens
  • Central Lab Solutions
  • Medical Device Clinical Trial Operations

For more information on the summit, and to book your place, click here

Interested in finding out more about the value of RBQM and CM?

Read our latest case study on what happened when we retrospectively applied our CSM solution to a completed sponsor-initiated Phase II Diabetic Kidney Disease trial database – and found serious data issues at 20% study progress. Had the CluePoints Solution been utilized during study conduct, our calculations show the problem site would have been discovered at least 16 months earlier, allowing the team to take timely corrective action and prevent potential study failure. Download the full case study here.