Online Extras

Chief Product Officer for Proscia, Nathan Buchbinder, discusses Proscia’s Concentriq and its benefits for CROs and life science organziations.

The recent industry-wide focus on widened access to health care, patient-centric approaches, and high-quality care have increased the interest in the concept of clinical research as a care option, Customer Project Manager of Trialbee, Hannah Van de Meek writes.

Integrating a systemic risk management strategy for identifying clinical trial risks-and the importance of applying change management techniques throughout the preparation, planning, and execution stages.

Executives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.

The history of gene medicine is filled with hope, tragedy, and successes. VP of Rare Diseases & Pediatrics for Premier Research, Angi Robinson, writes how patient well-being must always prevail, and challenges mustn’t stop us from helping solve unmet medical needs.

Examining the implications of shipping temperature-sensitive clinical supplies in an evolving clinical supply chain, including shipments direct to patient homes (DTP) and the need for temperature monitoring thereof.

A study conducted by Antidote Technologies and SCORR Marketing looks at what patient centricity means in clinical trials and the work that remains to realize the potential for better study designs.

The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements.

Clinical research is only as effective as its ability to have an impact on health.

In this Q&A, Helen Matthews, Jessica Morris, and Bruce Hellman offer their perspectives on the priorities, opportunities, and challenges of patient centricity in real-world evidence collection.

Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry.

Remote trials have the potential to increase recruitment, reduce attrition, and make patients feel more engaged with the research.

The world of data management today is practically synonymous with electronic data capture (EDC).

Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites.

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).

Real-world evidence (RWE) is needed in addition to clinical trial data to understand drug effectiveness in a real-life setting and to profile patient populations in terms of their clinical characteristics and drug utilization.

It is important to devote quality time to challenge yourself and your teams on whether there is a need to strategize and rethink the way you are conducting teleconferences for your clinical trials.

Examining the barriers, challenges, and outcomes to determine the effectiveness of different RBM implementation approaches.

Outlining the potential of three mHealth technology approaches in enabling novel and more robust clinical outcomes measurements.

Have you seen many paradigm shifts lately?

Survey highlights thoughts on digital integration, managing data sources.

Survey uncovers key findings amid today’s explosion of data volume and sources-and the added complexity in managing clinical data.

The exponential growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.

The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.

There are several important factors which should be considered prior to resorting to international patient recruitment.

Healthcare professionals are engaged in an increasingly competitive fight to attract and retain clinical trial participants through the use of user experience (UX).

Although it is unlikely that mock demonstrators will be seen at any drug information or regulatory conferences, pharmacovigilance software is indeed having its “Salesforce” moment.

To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.

This article delves into the why, when, and how a patient-centric approach should be adopted for both the benefit of patients and the successful development of novel and innovative medicines.

What technologies ease clinical trial laboratory sample and data management, and what are the benefits?