digital_BLINK: Trends for digitalized Clinical Evaluation Documentation: Integration of SOTA & Claim Management
15:00 - 16:00
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avaClinical 2.0: Enhanced features & traceability of information

Do you have an efficient and established clinical evaluation process? Or are you frustrated by all the documents, cumbersome copy & past actions and discussions with notified bodies about required content in documents?

Clinical Evaluation is still a hot topic in Europe with numerous MDCG guidances published in the last years and a new ISO standard on the horizon in the near future.

Due to the large amount of different data sets that need to be collected, appraised, analyzed and integrated into various documents, the digitalization of clinical evaluation activities offers particularly great potential.

The benefits of process digitalization are numerous – easy reuse of information for consistency, seamless integration into interface processes, and automated creation of content in documents are just a few examples.

The newest update of our established product, avaClinical, now provides additional functionalities for state of the art (SOTA) literature reviews and integration of such information in CEP and CER.

Furthermore, more and more companies are struggling with the management of marketing claims and demonstration of evidence for single claims. We provide now separate functionalities addressing this challenge.

In this webinar, we will introduce you to the new features in avaClinical 2.0 and their benefits, including the following topics: 

  • Introduction: Digitalization of the clinical evaluation process
  • Pains and gains: What troubles our users experienced in the past and how avaClinical is the answer
  • State of the Art: How the SOTA provides valuable input for CEP and CER
  • Claim Management: Centralize your marketing claims and create traceability to clinical and non-clinical evidence
  • Q&A: Opportunity to chat and field questions with our clinical evaluation experts Sarah Panten & Dr. Lisa Schell

A sneak preview of what is included in avaClinical 2.0:

  • Systematic collection and review of SOTA information, including derivation of benchmark criteria for performance and safety parameters
  • New claim management process allowing complete traceability from planned to released claims along with a trace to clinical and non-clinical data as well as relevant marketing materials
  • Optimized literature review process including the possibility for application of IMDRF adverse event coding during literature evaluation
  • Additional features for better structuring of information related to complex product portfolios

We are looking forward to seeing you there!

Register now
Speaker | Organization
Sarah Panten
Sarah Panten
Strategic Business & Portfolio Development
Dr. Lisa Schell
Dr. Lisa Schell
Digital QM/RA Consultant / Product Application Expert
Sylvia Berndt
Sylvia Berndt
Strategic Marketing & Communication Manager