
ABOUT PREMIER RESEARCH
Built for Biotechâ„
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 Biotechâ„ 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 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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Gain insights into how innovative silico modeling is revolutionizing rare disease drug development and opening new possibilities for accelerated research.
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When launching an RFP, refer to this checklist to ensure comprehensive coverage of all aspects when evaluating potential research partners for the rare disease study.
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Get a comprehensive and insightful overview of the latest advancements in CAR-T cell therapy and their potential to transform cancer treatment.
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Study transitions are inherently challenging. Here’s what teams should know to stay informed, keep processes aligned, and successfully transfer data.
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Consider the severity of the disease, the availability of existing therapies, and more when deciding whether or not to use placebo control in rare disease trials
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For sponsors considering a Bayesian response-adaptive style design, review this guide for tips to consider prior to developing a clinical study protocol.
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Sponsors looking to differentiate their trials and inspire patient interest should consider these five tips to proactively demonstrate their commitment to addressing unmet therapeutic needs.
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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.
-
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.
-
Have common questions concerning the IVDR product classification system addressed and learn how to comply with new clinical evidence and performance expectations.
-
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.
-
Learn why teams are putting an increased emphasis on creating processes and frameworks to encourage sustainable patient partnerships and establishing a paradigm of patient-centered research.
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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.
-
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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Early-stage clinical trials tend to focus on toxicity assessment and dose selection, which requires careful planning in study design and execution. Explore nine tips to improve precision oncology study processes.