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Study Design

Clinical Research: Phase 1 - Phase 4

Neonatal Research Insights: Conducting Clinical Trials in the Smallest Patients

Despite the passage of various legislative initiatives aimed at increasing the frequency and quality of pediatric clinical trials, neonates continue to be treated with medicines that have not been studied or approved in this population.1 Historically, sponsors may have felt that the ethical and logistical challenges limited the opportunities for neonatal research. Our experience has...

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Data Management & Biostatistics

Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm?

In times of crisis, there is often value in taking a step back and reassessing some of the traditional ways of doing things. As the clinical research community tackles the issues COVID-19 has raised for ongoing and future studies, we at Premier Research are meeting the challenge of developing alternative paradigms and new ways to...

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Clinical Research: Phase 1 - Phase 4

Med Ad News – Optimizing Early Oncology Studies Through Adaptive Trial Designs

Despite advances in technology and our understanding of the genetic and molecular underpinnings of cancer, making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. In fact, a recent review revealed that, among 59 cancer drugs approved by the U.S. Food and Drug Administration (FDA) based...

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Clinical Research: Phase 1 - Phase 4

Understanding New FDA Guidance for Pediatric Oncology Studies: A Sponsor’s Guide to the FDA RACE for Children Act

Summary The Research to Accelerate Cures and Equity (RACE) for Children Act The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are relevant to a...

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Clinical Research: Phase 1 - Phase 4

Best Practices for Interventional Cardiovascular Medical Device Trials in Asia

The emerging markets of the APAC region offer tremendous potential for clinical research. Best practices for cardiovascular medical device development in Asian countries can offer insights on navigating the regulatory and clinical landscape of this region. Widely recognized as one of the most important growth frontiers for medical devices, the Asia Pacific (APAC) region comprises...

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Clinical Research: Phase 1 - Phase 4

Unlocking the Full Potential of Precision Medicine in Oncology

Related Webinar: The Role of Adaptive Trial Designs in Early Oncology Studies Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances...

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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...

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Clinical Research: Phase 1 - Phase 4

The Challenges in Fulfilling the Promise of Personalized Oncology

Personalized 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 personalized oncology have been made in the area of cancer immunotherapy,...

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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. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...

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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...

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