Consulting

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,...

Clinical Research: Phase 1 - Phase 4

Understanding Recent Regulatory Changes for Pediatric Oncology Trials

Of the 1.7 million new cases of cancer in the U.S. in 2018, 10,590 involved children aged 14 or younger.[1] While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for...

Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis is challenging, given the often-delayed onset and diversity of symptoms. Operational challenges associated with clinical trial development complicate things even further. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial.

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

3 Critical Challenges: 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,...

Consulting

Strategic Planning for Compliance with the EU Medical Device Regulation

The changes are significant. Here’s what you must know. Makers of medical devices must build compliance into product development to comply with the EU Medical Device Regulation (MDR). Our white paper looks at key rule changes under the MDR, such as an expanded definition of what constitutes a medical device, the increased need for clinical...

Consulting

Best Practices For Interventional Cardiovascular Medical Device Trials In APAC

The Asia-Pacific region (APAC) is prepared to be key in addressing one of the word’s great health concerns. In our aging society, heart disease has become one of the most significant health problems worldwide. Its incidence is forecast to increase steadily as the number of people aged 60 and older is expected to double by...

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...

Consulting

In the Spotlight: Recent FDA Updates and Guidance for Rare Disease Drug Development

The US Food and Drug Administration (FDA) just updated its 2015 draft guidelines for drug discovery in rare diseases. The January update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of...

Consulting

Premier Insight 259: In Clinical Trials, Success Isn’t Always Where You Expect It

When does a clinical trial that falls short of its goal still constitute success? When the experience reveals invaluable lessons in how to avoid a repeat performance — and identifies a highly productive location for siting future studies. A large, multinational study of a drug to control inflammation in patients with recurring high-grade malignant glioma...