February 2, 2022

How to Establish the State-of-the-Art Within the Scientific Validity Report

How to Establish the State-of-the-Art Within the Scientific Validity Report

In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines. 

Key Takeaways: 

  1. The foundational role of the SOA in the SVR 
  2. The required components of the SOA such as the safety and performance objectives 
  3. The importance of a robust systematic literature review (SLR) to support your SOA 

Who should attend?

Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are develop, write, review, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well.

Click here to register and submit any questions you have for our presenter to answer.


A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.

In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.

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November 2, 2021

[FREE WHITE PAPER] Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

Overview

This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)-compliant SLR.

Leveraging published data can help meet global regulatory expectations, fill knowledge gaps, and inform internal decision-making. This applies to IVDR and Medical Device Regulation 2017/745 (MDR) requirements, but for the sake of providing an example, we focus on IVDR here. A methodologically-sound SLR can leverage published data for critical IVDR-required reports (e.g., the Scientific Validity Report, clinical performance). Remember, an SLR is far more than an internet search. It is a clear and robust plan for the identification, retrieval, selection, appraisal, and weighting of published data. SLR has long been the “gold standard” process for evidence-based research, especially in the academic and professional arenas. In today’s regulatory landscape where rigorous methodological SLR principles are now being mandated, adopting a transparent and reproducible process for literature reviews is essential. Every methodologically-sound SLR has 5 clearly defined steps…

Download the rest of this white paper here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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October 21, 2021

[FREE WHITE PAPER] How to Establish the State-of-the-Art Within the Scientific Validity Report

Overview

This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).

The SVR is a critical component of the IVDR in that it establishes the association of the analyte with the clinical condition or physiological state. Regulators expect manufacturers to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged as SOA. To establish that your IVD reflects the current best-practice, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA. Here, we discuss the critical role of the SVR in establishing SOA as it relates to the overall performance evaluation process.

Solution

The SVR is your chance to …

Download the rest of this white paper here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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September 15, 2021

How to Establish the Competitive Landscape Within the Scientific Validity Report

how to establish the competitive landscape within the scientific validity report with the state of the art search

In this practical presentation, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed.

You will learn:

  • The importance of the SOA SLR for providing background and general information
  • How to establish acceptance criteria with data
  • How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission. Also, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend.

Watch the recording!

Building a Solid Foundation for your PER to Support IVDR Readiness

Watch our recent webinar where we present an overview of the State of the Art section. Namely, we explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER). In addition, a complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed establish your IVD as “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

You will learn:

  • The importance of planning and preparation before you even begin to write the SOA
  • The complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)
  • The potential impact  of incorrect/incomplete documents or processes

To watch the free webinar recording, State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness, click here.

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August 5, 2021

[FREE WEBINAR] How to Establish the State of the Art Within the Scientific Validity Report

Click here to watch the recording of this webinar.

In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.

Key Takeaways:

  • The foundational role of the SOA in the SVR
  • The required components of the SOA such as the safety and performance objectives
  • The importance of a robust systematic literature review (SLR) to support your SOA

Who Should Watch:

  • Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER

Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.