Guides

Clinical Research: Phase 1 - Phase 4

A 7-Step Roadmap for Operationalizing Large‑Scale Clinical Validation Studies

Liquid biopsy tests represent both a promising alternative to existing screening methods and an opportunity to develop cancer detection tests for indications where no such screening method is yet available. Given the risk associated with both false positives and false negatives, liquid biopsies intended for screening and early cancer detection are subject to a high...

Clinical Research: Phase 1 - Phase 4

5 Tips for Designing and Operationalizing Natural History Studies

Natural history studies document the natural course of a disease, starting just prior to its inception and progressing through its pre-symptomatic phase and different clinical stages until the patient is cured, chronically disabled, or deceased. These studies play a crucial role in drug development—especially for rare diseases. In addition to providing insights that advance discovery...

Clinical Research: Phase 1 - Phase 4

Accelerating the Path from Concept to Market. We are Made for MedTech™

From pre-market pilot to post-market clinical investigation, we have vast experience across all stages of clinical development. With more than 165 projects conducted globally within the last five years, our medical device expertise covers a wide range of medical devices across all classes. As a dedicated MedTech business unit within a global CRO, we support...

Operationalizing Gene Therapy Studies for Success

Gene therapies are complex, and so are the clinical trials necessary for establishing their safety and efficacy. Given their complexity and the potential need for long-term follow up, gene therapy studies require highly qualified sites and highly engaged patients. In fact, the ability to select the right sites and patients can be the difference between...

Embracing the Intricacies of Rare Disease Cell and Gene Therapy Trials: A Guide to Overcoming Obstacles

Cell and gene therapies offer great promise for rare diseases, where patients—many of them children—may be severely ill or debilitated and treatment options are often limited. Development of these advanced therapeutics is complex due to both disease-specific and treatment-related factors and executing clinical trials that meet the expectations of regulators requires careful attention to study...

Paving the way to greater effi­cacy and safety of cell therapies

Cell therapy clinical trials remain extremely complex and seamless study execution is contingent upon tightly coordinated logistics and proactive toxicity management. This is where Premier Research can help. To read more, download the complete guide

5 Steps to Planning and Executing IND-Enabling Nonclinical Studies

Nonclinical studies demonstrating the safety and pharmacological activity of a compound are critical components of an investigational new drug (IND) application. Data gathered from IND-enabling tests is necessary for transitioning drugs into first-in-human (FIH) clinical trials, so generating high-quality data is essential. In this checklist, we outline five steps for planning and executing scientifically rigorous,...

7 Strategies for Increasing the Probability of Success in Neuroscience Trials

The worldwide prevalence and burden of central nervous system (CNS) disease is high and increasing, in part due to the aging of the global population. In the US, at least 5.5 million people have been diagnosed with Alzheimer’s disease, approximately 1 million live with Parkinson’s disease, and roughly 40 million cope with anxiety disorders. Despite...

U.S. IND and EU CTA Submissions: Can You Spot the Difference?

Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions, in the U.S. and Europe, respectively, are key milestones in drug development that mark the transition from bench research to first-in-human trials. Understanding the nuances of each and the differences between them is a crucial step in setting the drug sponsor up for success on...

Development Strategy

Accelerating Innovation Together

Expert Solutions from Concept to Commercialization Across the development lifecycle, our integrated solutions and cross‑functional team provide customized support for your program—Built for Biotech declares our mission and our mantra. Our all‑encompassing and all‑in perspective blends strategic thinking with hands‑on experience across every aspect of development, helping biotech, specialty pharma, and MedTech innovators turn brilliant...