Pharmaceutical companies must build inspection readiness strategies into their quality structure. If they are not inspection ready, their application is at risk of being denied, and that can cost a pharmaceutical company millions of dollars. To achieve inspection readiness, a company must ensure the following: 1. Rights, safety, and welfare of their subjects are protected; 2. Clinical trial data is accurate and reliable; 3. Compliant with health authority regulations, company’s SOPs and GCP standards. At the end of this presentation attendees will understand how to identify and mitigate potential compliance gaps and implement a systematic approach to inspection readiness.

Data integrity is of utmost importance to the success of a clinical trial, and modern data collection techniques require new methods of oversight and validation. This presentation will focus on ensuring the quality and integrity of ePRO data in large, complex studies with varied types of sites. ePRO data should be able to withstand scrutiny from regulators, and this talk will outline some of the challenges and methods of data surveillance and analysis to ensure quality and integrity.

The COVID-19 pandemic had numerous disruptive effects on clinical trial execution. It was especially disruptive to site monitoring practices and was the impetus for more widespread adoption of risk-based approaches. This session will review the impacts of the pandemic on RBQM implementation, including challenges and lasting positive trends.

If 'quality' is everyone's responsibility, how do the pieces of risk-based quality management fit together This presentation will consider the requirements for an end-to-end RBQM framework; discuss roles, responsibilities, and connections; and most importantly, review how clinical quality is the currency between all roles and deliverables in the RBQM methodology​.

Since ICH E6 was first introduced in 1996 there was no update until 2016. And we already have another draft update! ICH E6 R2 introduced the section on Quality Management. The proposed update to that section in ICH E6 R3 could be taken as minor word-smithing such referring to a "harm/hazard" rather than an "error". Or the change from "predefined quality tolerance limits" to "acceptable ranges". Will these and other proposed changes improve implementation of RBQM, make no real difference, or might they hinder? At this session you will hear a seasoned professional's view of the potential impact of the proposed changes and can join in the discussion.

Clinical Data Science meets Audit Trail and Meta Data and the result is higher quality and insight. This use-case shows how a team with strong coding skills is able leverage Audit trail and Meta Data for informing site process performance and site audits. We will review the business case and the tools that were developed to meet the needs of the study team.

One of the fundamental pillars of RBQM/central monitoring is identifying signals and potential issues at sites and assigning actions to the study team to address the signals and/or issues. What happens when a study is conducted over a long period of time and study teams become fatigued with the RBQM process and show resistance to new actions? This talk will explore how the speaker researched central monitoring related action rates within her company and explored methods to revive actions on long running studies.

RBQM+ on paper seems like a straightforward activity. Carry out a risk assessment on the protocol, critical data and trial processes, document mitigations, and implement a monitoring strategy for the risks, including centralized monitoring. The reality, however, is that RBQM is a culture shift on how we conduct clinical trials.  RBQM is not just about tools, it is about people and acceptance of a new way work on trials.

In recent years, collaboration within the biotech and pharma sectors has significantly surged. In this presentation, we'll examine the role of open-source tools in fostering collaboration, transparency, and standardization across industry. We'll also provide an overview of current open-source initiatives in the clinical trial domain, including  Safety Monitoring, Data Standardization, and a newly-released open source framework – containing 30k lines of code – for Risk-Based Quality Management (RBQM).

Source Data Verification (SDV, transcription check performed by Site Monitor) has been believed to be the fundamental quality ensuring activity in the era of paper Case Report Forms. I will present data on the effectiveness of Source Data Verification (SDV) in warranting quality of studies delivered according to the principles of Risk-Based Quality Management and discuss whether there’s a place for SDV in a modern study monitoring framework.

In times where change is rapid, let's explore ways to provide business management monitoring to ensure your process is robust and effective. Identify when it is time to evaluate a need for improvements or retraining. During this session, we explore key areas of oversight in your application of RbQM process and how to ensure highest quality within your clinical trials. 

DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes. This talk will discuss the post-COVID strategies for connected devices implementation in hybrid trials.

This talk will focus on the use of digital health technologies(DHTs) to advance medical product development—from assessment to interventions in real-world settings. I will share learnings from clinical research studies to help inform the development of robust digital endpoints and interventions focusing on improving behavioral outcomes.

This presentation will share the NIH Framework for digital technologies' validation in clinical trials.