Study Design

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.

Consulting

BIO International: Discover the Latest in Innovative Rare Disease Trial Design

DURHAM, N.C., June 5, 2019 — Premier Research is sponsoring the Orphan & Rare Disease session track at this year’s BIO International Convention, June 3-6 in Philadelphia. Our own Angi Robinson, vice president for clinical development services in rare diseases and pediatrics, will participate in the panel discussion Rare Finds: Innovative Clinical Trial Design for...

Consulting

Strengthening Neuroscience Clinical Research Through Innovation

There’s a lot of discussions these days about innovative ideas to make clinical research more patient-focused. The concept goes hand-in-hand with the development of technology that permits researchers to design and execute trials that can significantly reduce the burden of participation. Development of neuroscience drugs is benefiting from these advances in patient-focused research, as new...

Study Design

Pharmaceutical Outsourcing – Using Science to Drive Successful Study Strategy in Hematological Malignancies

Pharmaceutical Outsourcing – Using Science to Drive Successful Study Strategy in Hematological Malignanciesby Luke Gill, Vice President, Oncology, Clinical Development Services