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.
FEATURED PRODUCTS
More than a technology platform, discover how ePremier unifies Premier Research’s data-driven process, people, and resources to help propel biotech innovation.
RARE DISEASE
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![GettyImages-922717668 health form]( "Rare Disease And Precision Medicine: A Road To Growth")
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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![GettyImages-1421547005 doctor writing]( "How Patient & Caregiver Journeys Guide Rare Disease Study Designs")
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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![patient recruitment]( "From KOLs To Patient Advocates, Using Every Tool To Fight A Rare Disease")
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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![Getty Images- 1404912459 oncology]( "Can Your Protocol Flex? The Importance Of Adaptive Trial Designs In Precision Oncology Studies")
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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![The Changing Oncology Landscape]( "Premier Perspective On Biomarkers In Oncology")
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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![Europe iStock-490822468]( "Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial")
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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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Pursuing The Promise Of Gene Therapy: Pathways To Successful Clinical Trials")
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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![Lab cell and gene pipette GettyImages-162264253]( "Designing Robust Gene Therapy Studies")
Explore the key considerations for designing successful gene therapy trials in the available blog.
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![Why Has The Demand For Paediatric Products Increased?]( "Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial")
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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![GettyImages-523184134 diagnostics]( "IVDR Survival Guide Part 1: Classification, Clinical Evidence, & Performance Requirements")
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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![GettyImages-1227175550 unity]( "Establishing Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT Conduct")
Establishing Clinical Utility Of Molecular Diagnostics For Precision Medicine: 5 Tips On RCT ConductExplore five ways to approach designing and conducting a randomized clinical trial to demonstrate clinical utility.
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![GettyImages-842852944 study]( "Executing A Dual-Submission Study")
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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![GettyImages-863481734 drug development]( "5 Stepping Stones To The Future State Of Rare Disease Clinical Development")
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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![Sound Waves GettyImages-1293175706]( "Regulatory Considerations For Radiotherapeutics And Radiodiagnostics")
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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![MRI-brain-head]( "Navigating The FDA’s Draft Guidance On Psychedelic Drug Development")
Uncover new guidance for the development of innovative therapies in the realm of mental health and addiction treatment.
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![epremier video thumb]( "ePremier: More Than A Technology Platform")
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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![Research and Development-GettyImages-165181357]( "Expert Solutions From Concept To Commercialization")
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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![two-business-people-GettyImages-1354841430]( "When And How To Use ODD For Orphan Subsets")
Learn to develop customized and tailored strategic plans, mitigate regulatory risks, and optimize marketing success when securing Orphan Drug Designation.
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![GettyImages-1074166486-brain-scan-results-radiologist-doctor]( "Leveraging Tech And Clinician Review To Improve Risk Detection")
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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![iStock-1277148522-cancer]( "Liquid Biopsy As A Cancer Screening Tool")
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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![The End To End Importance Of Selecting The Right Biomarker In Cancer Studies]( "Where Biomarkers And Gene Therapy Trials Intersect")
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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![GettyImages-1386401112 patient diversity]( "Patient Participation Strategies In Gene Therapy Studies")
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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![GettyImages-946264212 bio samples]( "Meeting The Demands Of Liquid Biopsy Development")
Gain insights into strategies for designing and executing extensive validation studies for liquid biopsies intended for cancer screening purposes.
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![GettyImages-1391303942 patient doctor HCP]( "The Multi-Faceted World Of Clinical Trial Matching In Oncology Studies")
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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![GettyImages-639668490 patient]( "Bringing Patient Centricity To The Forefront In CAR-T Trials")
Empower patients during their CAR T-cell therapy treatment journey by utilizing these strategies for fostering patient-centricity.
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![DNA Digital Display]( "5 Steps For Success: Developing Digital Medicines & Digital Therapeutics")
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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![Proposed FDA Limits For Arsenic In Food Target Contaminants In Infant Rice Cereal]( "Accelerating Infant Formula Studies With Decentralized Clinical Trials")
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.
