
ABOUT PREMIER RESEARCH
Built for Biotech℠
Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping the most innovative biotech, specialty pharma and medtech companies take their best ideas from concept to commercialization. Our clinical research, product development and consulting offering bring a unique blend of industry acumen, global compliance and therapeutic expertise to support complex clinical programs with specialized patient populations and significant unmet needs.
Our Built for Biotech℠ model recognizes the importance of providing a holistic approach to the many layers and facets of clinical research. Let’s put this into perspective. Your compound may treat a particular cancer, but requires orphan drug designation for fast-track approval, a special adaptive design to accelerate study timelines, the need to enroll pediatric patients, interaction with patient advocacy organizations and careful strategies to ensure patients and their families are properly engaged to maximize retention. Our project teams are experts in this type of comprehensive delivery, supported by a flexible and agile corporate culture.
We offer cross-functional, customized solutions to meet you wherever you are in your development journey. From rare and orphan diseases, to oncology and hematology, to cell and gene therapies and medtech, our teams are here to serve as an extension of your team across all stages of development.
RARE DISEASE
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As precision medicine advances, discover how the timing of rare disorder diagnosis could be improved so that treatment can begin at earlier stages of the illness.
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Discover how designing trials that account for both patient and caregiver needs can improve the overall experience of study participation and may contribute to improved patient retention and higher-quality data.
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With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people this CRO had to make full use of what few resources were avaiable. By working with KOLs and a patient advocacy group they located their 18 patients ahead of schedule and completed the 26-week trial early.
ONCOLOGY
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Discover how adaptive trial designs work to limit the number of patients exposed to ineffective doses or treatments and accelerate detection of efficacy signals.
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Explore the common applications of biomarkers in oncology, with a focus on companion diagnostics and key considerations for incorporating biomarkers into clinical development programs.
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The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, and the approval pathway depends on product classification. This case study describes how product classification may not always be clear-cut, given the proliferation of novel approaches to ATMP development.
CELL AND GENE
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The promise of gene therapy is to provide transformative treatments that meaningfully improve quality of life for patients, many of whom are currently living with debilitating diseases. Explore the emerging landscape of gene therapy and high-level considerations for studies of these advanced therapeutics in this blog.
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Explore the key considerations for designing successful gene therapy trials in the available blog.
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A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.
MEDTECH
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Have common questions concerning the IVDR product classification system addressed and learn how to comply with new clinical evidence and performance expectations.
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Establishing Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT Conduct
Explore five ways to approach designing and conducting a randomized clinical trial to demonstrate clinical utility.
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Dual submissions can pose a range of difficulties for clinical trials. Gain insight into how multiple requirements can be addressed successfully with the right strategy.
NEWS
- Premier Research & InSilicoTrials Leverage Silico Modeling, Simulation, & Optimize Regulatory Pathways For Rare Disease Therapies
- Premier Research And CENTOGENE Launch Strategic Partnership To Accelerate And De-Risk Rare Disease Clinical Development
- Premier Research Names Jennifer Nezzer Vice President Of Biometrics
CONTACT INFORMATION
Premier Research
3800 Paramount Parkway Suite 400
Morrisville, NC 27560-6949
UNITED STATES
Phone: + 1 910 447 3156
Contact: N/A
FEATURED ARTICLES
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Review five essential steps that have the potential to propel rare disease clinical development into a new era of advancement and breakthroughs.
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Take a deep dive into diverse radiopharmaceuticals (RPs) and how developers and promoters of RP products are grappling with a regulatory landscape that can be intricate to traverse.
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Uncover new guidance for the development of innovative therapies in the realm of mental health and addiction treatment.
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Experience the unifying power of ePremier, which integrates Premier Research's data-driven processes, talented individuals, and valuable resources to drive innovation in the field of biotechnology.
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Get the assistance your teams need to translate exceptional concepts and groundbreaking science into transformative treatments that bring hope to those facing unmet medical needs.
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Learn to develop customized and tailored strategic plans, mitigate regulatory risks, and optimize marketing success when securing Orphan Drug Designation.
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Learn why neuroscience therapy developers should start adopting strategies to improve data quality and assess responses using a combination of technology and expert clinician review.
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Delve into the significance of early cancer detection and the present state of affairs, along with crucial considerations, when it comes to developing liquid biopsy solutions for cancer screening.
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Gain insight into several pivotal aspects involving gene therapy clinical development for rare diseases, such as biomarker selections and accelerated approval methods.
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Securing clearance for novel treatments is complex. Here, we review pertinent information on the optimization of the benefit-risk profile, the role of volunteers, and the importance of customization.
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Gain insights into strategies for designing and executing extensive validation studies for liquid biopsies intended for cancer screening purposes.
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Delve into strategies aimed at heightening awareness of clinical trials among patients and healthcare providers, enabling them to make informed decisions regarding study involvement.
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Empower patients during their CAR T-cell therapy treatment journey by utilizing these strategies for fostering patient-centricity.
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By addressing barriers to uptake and fostering adoption, discover how this five-step approach is able to pave the way for a transformative future in healthcare.
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Explore the ways decentralized clinical trials are addressing enrollment study challenges and empowering sponsors and CROs to reach a broader geographical pool of eligible participants.