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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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FREE ON-DEMAND WEBINAR
April 1, 2020

How to Estimate Sample Size for Medical Device Clinical Studies

The MDR is forcing many MedTech companies to conduct clinical studies to gather data for Post-Market Clinical Follow-Up (PMCF) and clinical evaluation.

One of the first crucial steps in designing a clinical study is determining the number of subjects to recruit i.e the study sample size.

To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning.

Watch for free
How to Estimate Sample Size for Medical Device Clinical Studies
This webinar will cover:
  • The basic inputs behind sample size estimation
  • How study design can impact sample size
  • How to prepare for a discussion on sample size with a statistician
Who should attend?
  • Clinical Affairs Professionals and Management
  • Clinical Operations Professionals and Management
  • Clinical Research Professionals and Management
  • Regulatory Affairs Professionals and Management
Register Now  

Hosted by

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PRESENTER:
JON BERGSTEINSSON

Co-founder,
Greenlight Guru Clinical (formerly SMART-TRIAL)
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PRESENTER:
OREN BAR-ILAN

Managing Partner,
DataSights

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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About DataSights

We focus on the pharmaceutical and medical devices industry. Our scientific and business orientation brings a unique perspective. It allows us to raise questions that sharpen the scientific questions of interest and address problems in a proactive manner.

Our expertise spans from non-clinical to clinical studies on small molecules, biologics and medical devices at all phases and in multiple therapeutic areas. We combine knowledge of innovative trial designs and novel statistical methodologies with significant experience in regulatory interactions including submissions and approvals.

Visit their homepage to learn more.

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