Speaker: Danielle DeLucy - Owner, ASA Training &
Quality Consulting, LLC
Date: December 7th Wednesday
Time: 01:00 PM EST | 10:00 AM PST
Duration: 60 Minutes
Product Code: 300183
Level: Beginner
Key Take Away
During this webinar, strategies for remote monitoring will be
discussed, including the review of data for trends, how to make the most of
writing queries, and what “red flags” to look for that may indicate issues on
site.
Overview
Across the industry, companies are striving to find ways to
improve operational efficiencies. Currently, over 80% of site-based
documentation today is still fully paper based, with both cost and risk
consequences for the entire clinical trial process. Specific liabilities
of a paper-based system include audit and inspection risk, reduced site
productivity, manual reconciliation of TMF and site records, as well as the
lack of visibility into site performance.
Strategies for saving time and money, without compromising
oversight and quality, are an ongoing challenge within the industry. In an age
where technology is ever present from ordering medications online, consulting
with a physician, and having “live” conversations in chat rooms about medical
issues, the clinical research industry has been slow to maximize the use of
technology.
Why Should You Attend
With sponsors/CROs implementing the FDA’s final guidance on a
risk-based approach to monitoring, time on site is being reduced to one day
visits and/or on-site visits are scheduled few and far between per monitoring
plans. Better utilization of remote monitoring is critical to ensure sites are
compliant and the data is accurate and consistent.
Areas Covered In This
Webinar
A variety of approaches can be used by sponsors to ensure
monitoring obligations are fulfilled. Traditionally, this has involved on-site
visits where monitors are required to check a high percentage of the data
entered on the case report forms (CRF) against source, to ensure that the protocol
is deployed correctly, and adverse events reported appropriately.
The size, complexity and number of clinical trials mean that
complete on-site monitoring is becoming an ineffective, expensive and
inefficient process. However, effective monitoring is critical for the
protection of subjects and the integrity of the data produced, meaning that
on-site monitoring is still required by regulation for critical study
parameters.
Remote monitoring is seen as an acceptable addition to the
process. To use remote monitoring effectively, a risk assessment must be
performed and included in the monitoring plan prior to the start of any
clinical program and adapted as the program evolves.
Learning Objectives
·
Describe approaches and techniques for remote data review
·
Explain techniques for query writing to ensure clear
communication of issues
·
Implement strategies to identify problem areas and how to
maximize time on site following remote monitoring
Who Will Benefit
·
Clinical Research Associates
·
Study Coordinators
·
Project Managers
·
CRA Managers
·
Validation specialists
Speakers Profile
Danielle DeLucy, MS, is an Independent Consultant to the
Biologics and Pharmaceutical Industries.
Danielle DeLucy, is owner of ASA Training and Consulting, LLC
which provides Pharmaceutical and Biologics based companies with training and
quality systems assistance in order to meet Regulatory compliance.
Prior to this role, Danielle has been in the industry for 15
years serving in numerous Quality Management Roles, such as the Director of
Product Quality, the oversight of Sterility Assurance practices and provided QA
oversight of numerous filling and packaging operations.
Danielle began her QA career as a Quality Control Pharmaceutical
Microbiologist at a contract laboratory where she performed various tests for
their clients. In the years after, she has held positions in the Quality
management arena while increasing her responsibility. She has helped to lead
many Regulatory Health Inspections and was instrumental in the coaching process
of her peers prior to any inspection.
Currently, Danielle assists companies who are faced with warning
letters, consent decrees and those wishing to improve compliance establish more
robust quality systems so that the company can succeed.
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