This session is aimed at sponsors who want to bring some discipline back to their TMF and at CROs and other vendors who want to partner effectively with them. We’ll cover industry standards for content; document handling for electronic/paper hybrids; best practices for corralling TMFs dispersed across multiple vendors; and techniques for ensuring that substantive issues are well-documented.
In this course, you will learn to navigate common challenges faced when planning/executing regulatory and validation projects, ensuring that they are completed on time and within budget.
Successful completion of these three training sessions is intended to meet the needs of individuals who are either new to biopharmaceutical-based document management, Information Management, and regulatory submission publishing for health authorities, or already experienced in one area and looking to gain a broader understanding of the full continuum of regulated document and submission production activities.
Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Building a quality risk management program and implementing technology will be critical in strategies to increase quality and efficiency and deliver accurate analyses of clinical study site performance and data quality.
To help you navigate the confusing waters of bringing regenerative medicines to market, LSTI has partnered with the law firm of Fuerst Ittleman David & Joseph, PL to offer a webinar that will help you make sense of the pending regulatory landscape so you can be prepared for any eventuality.
This Investigator Good Clinical Practice (GCP) course takes the requirements of GCP for clinical trials found in ICH E6 GCP related to the role of the investigator working on a clinical trial for a sponsor/CRO. The required activities related to the investigator GCP roles and responsibilities are presented with case studies to reinforce key concepts and emphasize critical activities that if not performed well or delegated appropriately for a study, can be increase risk toward maintaining protection of human subjects and ensuring data integrity.
Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors.
Using a “risk-based” approach has paid big dividends in clinical trials, as its principles are applicable to many different functional areas. This is no more visible than when applied to the oversight of Clinical Research Associates (CRA).
Quality risk management must now be a focus of any clinical quality system for all stakeholders, including investigative sites. Most sites have not incorporated the benefits of a risk-based approach to study conduct.
The National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are suggesting a standardized format for protocols utilized in conducting Phase II and III clinical trials under an IND (Investigational New Drug) or IDE (Investigational Device Exemption). Investigators applying for NIH grants must use this template.
Good Clinical Practices (GCP) are an integral part of your ability to design and execute clinical studies. The principles behind GCP provide the compliance and regulatory framework for how your trials must be conducted.
Far too often, companies select and contract with a Contract Research Organization (CRO) without conducting a “due diligence” audit for GCP compliance. Even when sponsor firms do audit potential CRO partners, the review is often substandard or misses key GCP qualification points, ultimately putting deliverables, data, and other critical activities at risk.
Even with increased efforts to harmonize regulatory requirements between the US and European Union, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have different requirements for initiating and conducting clinical trials for medicinal products. Deciding which standards to follow and how to harmonize/organize your own efforts is a daunting task.
This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.
A review of case studies from failed clinical projects shows that the most costly decisions happen at the beginning. When you strategize and keep the most critical factors in mind, you will set yourself up for greater success, and this session will start you on that path.
This detailed, 90-minute session will help you navigate complex relationship strategies with CRO/Vendors and brainstorm ideas to set you up for success.
