Round Tables

TechnoSTAT would like to invite you to attend a lecture dedicated to Medical directors and CEOs in Pharma and medical device companies currently at their initial clinical trial development stages or about to start their next clinical trial.

We regularly initiate round tables for the benefit of our sponsors and the industry and invite to join us.

Past Round-Table:

Missing (and other problematic) Data in Clinical Trials

How problematic data may (or may not) affect the validity of your clinical trial outcome

Lecturer: Dr. Yossi Tal is President of TechnoSTAT Ltd.

The Roundtable presentation will explain how missing data, and other types of problematic data such as outliers, can threaten the validity of your clinical trial. A general framework for addressing the issue from the statistical/regulatory standpoint will be presented. Topics will include:

• Types of problematic data (and “non-data”)

• Approaches to addressing these problems in a manner acceptable to FDA

• Difficulties, Solutions and what FDA Expects

Monday November 23, 2015

How eSource Methodologies are Transforming Clinical Research

The impact on Patients, Clinical Sites, Clinical Operations and Regulators as Paper Records Disappear

Lecturer: Jules T. Mitchel, MBA, PhD, President, Target Health Inc., NY, NY

The Roundtable will include topics on how using eSource records in lieu of pen and paper affect:

  • Sites Feasibility- Pre study visit qualification sites
  • Monitoring of clinical trials
  • Source Document Verification
  • Query Management
  • Data Management
  • Regulatory Review

Monday May 11, 2015

Overview of the US Healthcare System:

How does the Reimbursement System in the US Affect Business Strategy?

Lecturer: Debbie Garner

EMEA Regional Director, Avalere Health LLC

The lecture will include topics on Reimbursement Basics and Reimbursement by Type of US Payer:

• Medicare

• Medicaid

• Commercial/Private Payers

• Facilities & Providers as Customers: Hospitals, Post Acute/Long-term Care

• US Healthcare Reform

Sample Size and Submission

Lecturer: Dr. Yossi Tal, TechnoSTAT president

Sounds simple, doesn’t it? Well, as you know, it is not. Determining sample size for an FDA pivotal trial depends on numerous factors including:

• Type of product: Therapeutic device, diagnostic device, drug, 510k, PMA, NDA, etc.

• Primary objective: Efficacy, safety, diagnostic performance, etc.

• Trial design: Multiple-arm, single arm, superiority, non-inferiority, single analysis, interim analysis, etc.

• Luck: Good, better, best, etc.

Plan Before You Act

Optimizing the Implementation and conduct of your Clinical trial

The topics discussed should contribute to the professional and cost effective conduct of clinical trials. We will be happy to share with you our experience and expertise on start-up activities and monitoring

For more information about our next round table you are welcome to contact us at  info@technostat.co.il