Clinical Trial Compliance & Operations Tech, IRT, RBQM, RTSM

CLINICAL TRIAL COMPLIANCE & OPERATIONS TECHNOLOGY INSIGHTS

Not What I Expected From A Vendor Conference
Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites.
KPIs To Consider When Evaluating Success With New Site Technology
Consultant Aurea Flores, Ph.D., offers specific advice for evaluating whether a new technology is embraced by site staff and fulfilling its purpose for the sponsor.

The Pendulum Of RTSM Configuration Vs. Customization

As technology continues to evolve, learn how IRT systems can no longer be implemented into the fabric of the organization, but rather need to ebb and flow with the needs of clinical trials.
An Introduction To One Home for Sites™

This on-demand webinar provides a thorough overview of why IQVIA Technologies is building One Home for Sites, how it works, and who should participate.
How Long Is Your RTSM Risk Mitigation List?

While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.

Using Holistic Risk-Based Oversight, We Can Focus On A Trial's Most Critical Factors

The industry anticipates a transformative shift towards embedding RBQM as a foundational practice in modern clinical research as a means to enhance trial efficiency and safety.
Implementing ICH E6 (R3) In A Risk Averse Culture

Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.
RBQM For Decentralized Trials: Two Key Areas Of Focus To Reduce Your Risk

This article takes a more in-depth look at Sections 5.0.5: ‘Risk Communication’ and 5.0.6: ‘Risk Review.’ in ICH-GCP E6 R2 to show how the implementation of RBQM can reduce issues and achieve holistic trial oversight in today’s complex decentralized trials.

The Pendulum Of RTSM Configuration Vs. Customization

As technology continues to evolve, learn how IRT systems can no longer be implemented into the fabric of the organization, but rather need to ebb and flow with the needs of clinical trials.
How Long Is Your RTSM Risk Mitigation List?

While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.
Why You Should Expect More from Your IRT/RTSM

Explore the need for advanced capabilities beyond basic RTSM and the importance of having experienced teams behind IRT solutions to navigate complexities and ensure successful trial execution.

eISF In European Clinical Trials And How eBinders Can Help

By addressing the unique hurdles tied to regulations in European clinical trials, eBinders offer a streamlined approach to managing electronic trial documentation.
eReg Benefits For Clinical Research: Use Cases For All Types Of Sites

Unearth the different kinds of eRegulatory use cases for diverse clinical site types and other eRegulatory capabilities designed to serve all sites.
FDA Guidance Has Implications For EDC And EHR eSource Capabilities

Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.

Enhancing Participant Payments: A New Approach

Managing participant payments in clinical trials is a multifaceted challenge impacting participants, sites, and sponsors alike. Delve into the intricacies and numerous hurdles faced in this process.
Navigating The Complexities Of Clinical Trial Site Payments Forecasting

Advanced technology and best practices have the potential to revolutionize clinical trial site payment forecasting, leading to significant improvements in overall trial efficiency and management.
From Nice-To-Have To Must-Have: The Importance Of Patient Convenience Solutions

Seasoned clinical research expert and advocate of data ethics Angela Radcliffe discusses how the industry can enhance the lives of both patients and clinical trial sites.

Automation Is Not Just AI

Hassan Khalid of AstraZeneca and Jessica Jolly, a senior data and science executive, talk about the advantages of automation as a result of a Guidance like ICH M11, and why “automation” is not synonymous with AI in this case.
Can CDOs and CDAOs Evolve From Monotonous SOPs & Reg Filings?

Jessica Jolly, a senior data and science executive, is challenging CDOs (chief data officers) and CDAOs (chief data & analytics officers) to stop putting the data science community “to sleep” with the traditional monotonous SOPs, and instead, move more toward autonomous governance by design.
Selecting And Evaluating An eRegulatory Solution

Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.

Streamline Financial Management Of Clinical Trials

Enhance your Clinical Trial Payments solution with IQVIA Forecasting to leverage our global expertise and navigate the complexities of payments with ease.
Forecast And Budget Investigator Grants Confidently

As the only solution that integrates data from all industry sources, IQVIA GrantPlan delivers Fair Market Value itemized costs, empowering users to confidently plan budgets for studies worldwide, across all phases and therapeutic areas.
Transforming Clinical Trial Site Forecasting

In today’s ever-evolving clinical trial space, managing the expenses associated with conducting a study is more important – and fraught – than ever before.