March 9, 2022

[Ask the Expert] Clinical Data for IVD

Clinical Data for IVD: What is it and How Do I Find It?

Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing, we will provide insights and suggestions to help make the process of data collection, extraction, and presentation more streamlined.

This forum answers question like these and more. Click here to watch the recording.

Who watch this forum?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions.

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

The implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition, establishing clinical performance of their products is key. However, many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR). Finally, screening, selection and data extraction are typically challenges for manufacturers as well.

In this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next, using case studies, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).

Key Takeaways:

  • Review the essential steps for conducting a robust, methodologically-sound systematic literature review
  • Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.

Watch this webinar recording.

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November 3, 2021

[Ask the Expert] The Importance of Clinical Data

The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER

Do you have questions about how to generate, collect, analyze, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you effectively present your data in your clinical evaluation report or performance evaluation report?

During this 45-minute Q&A session, our President Laurie Mitchell is joined by Dr. Sarah Chavez  to answer some commonly asked questions and give expert advice. Answers cover how to best collect and present data on similar (competitor) devices as well as data collection strategies for new products. In addition, there is discussion around best practices for and examples of appraising literature and clinical data. Also, clarification between safety & performance metrics and risks & benefits analyses is given, plus so much more.

Watch the recording!

Who should watch this forum?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions.

How to Empower Data-Driven Decisions in Your Organization

Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.

You can also watch our webinar on this topic.

Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:

  • Examples of how the use of published data can support regulatory expectations
  • When to conduct a systematic literature review
  • Best practices for conducting a methodologically-sound SLR
  • Use of available tools and technology
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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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September 1, 2021

[Ask the Expert] Systematic Literature Review

systematic literature review

This session’s topic: Systematic Literature Review: What is it and why is it so important?

Do you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR​​. In addition, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions, meta-analyses, regulatory response support, development of clinical marketing materials, etc.

Watch the recording!

Watch Our Related Webinar for an In-Depth Look at the SLR Process

With the implementation of IVDR and MDR requirements, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process, including screening, selection and data extraction. 

Watch our webinar where we break down the steps of the SLR process and take 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). We encourage professionals from the medical device industry to watch as well, as the content is also relevant to MDR requirements, which align closely with IVDR.

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