Study Design

Clinical Research: Phase 1 - Phase 4

Cardiac Device Trials in Asia-Pacific

Accessing the region’s large and aging population The fast-growing Asia-Pacific (APAC) region is home to 60 percent of the world’s population and bears a growing burden of cardiovascular (CV) disease. Access to treatment-naïve patients, lower trial costs, and attractive prices for medical procedures make APAC countries increasingly appealing to cardiac and other device researchers—but there’s...

Clinical Research: Phase 1 - Phase 4

High Potential: Precision Cancer Drugs

Realizing immuno-oncology’s life-changing promises Immunotherapy is dominating advances in oncology drug development, paving the way for a new standard of cancer care. CAR T-cell therapies are some of the most powerful tools and are among the most widely studied investigative products, with more than 640 clinical trials now underway worldwide. Here’s a look at the...

Clinical Research: Phase 1 - Phase 4

Considerations for Operationalizing Pediatric Oncology Studies

Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By closing the orphan drug exemption loophole and enabling earlier discussions with the FDA, the Research...

Clinical Research: Phase 1 - Phase 4

The Challenges in Fulfilling the Promise of Precision Oncology

Precision oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides toward the paradigm of precision oncology have been made in the area of cancer immunotherapy,...

Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. A survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. The report found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and...

Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

Clinical Research: Phase 1 - Phase 4

Considerations In Conducting Pediatric Clinical Trials

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions...

Consulting

Ethical Considerations in Adaptive Design Clinical Trials

An adaptive design clinical study is one that includes a prospectively planned opportunity for modification of one or more aspects of the study design and hypotheses based on interim analysis of study data. The overall objectives of an adaptive design approach are to make clinical trials more efficient, more informative, or more likely to demonstrate...

Clinical Research: Phase 1 - Phase 4

Premier Research And NUHS Centre For Innovation In Healthcare (CIH) Partner To Facilitate Adoption Of Health Innovations

SINGAPORE, AUGUST 20, 2019 — A strategic memorandum of understanding (MOU) has been signed between Premier Research and the Centre of Innovation in Healthcare (CIH), part of the leading academic institution National University Health System (NUHS) in Singapore. CIH is a one-stop hub that facilitates the clinical adoption of health innovations for maximum benefit to...

Quality

Planning for Quality in Medical Device Clinical Trials

Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional on-site monitoring to risk-based monitoring requires cross-functional collaboration and careful planning.