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
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.
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.
- 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
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.