ABOUT PREMIER RESEARCH

We’re built for biotech

We recognize that when an emerging biotech is built around a single asset, focus and flexibility are critical to success. 

And, since many of our customers require additional infrastructure, we fill in resourcing gaps to help their product reach the patient faster. We are a mid-size CRO and offer strategies that are customized for each program, with tailored processes designed to meet highly specific needs. 

Firsthand experience with many different systems and processes informs our decisions on what will work best for individual customers. We complement our customers’ team with specialized expertise in your therapeutic area and reduce the burden of analysis. 

Premier Research leverages leading technologies and predictive recruitment models, so that our teams can build statistical, adaptive approaches and find efficiencies that support Fast Track designation and orphan drug status. 

We’ve created a specialized global team dedicated to protocol development and accelerating investigator site selection for study startup. Our regulatory consultants are available throughout development from phase I through post-marketing to support trial design, regulatory submissions, and compliance.

We are adaptable, passionate, and customer-focused — smart, experienced, and united by a desire to help change the course of medical science. We’re constantly building on our past successes to have direct impact on the outcome of our customers’ development plans. If you’re looking for a clinical development partner that delivers outcome-focused insight and shares your commitment to developing life-changing therapies, we should talk.
 

FEATURED PRODUCTS

End-To-End Oncology Development End-To-End Oncology Development

Pioneers developing the latest targeted therapies turn here for innovation and expertise. We’ve conducted over 155 trials across numerous indications in the past five years.

CONTACT INFORMATION

Premier Research

One Park Drive

Durham, NC 27709

UNITED STATES

Phone: + 1 910 447 3156

Contact: Karen Brown

FEATURED ARTICLES

  • Parkinson’s: Why Has Disease Modification Failed — And What Now?
    Parkinson’s: Why Has Disease Modification Failed — And What Now?

    Researchers have made many attempts at disease modification as they pursue breakthroughs in treating Parkinson’s disease, but so far without success. Why have these efforts failed, and what’s next in treating this degenerative disorder that affects an estimated 10 million people worldwide? In this blog post we examine these past attempts, why they failed, and what targets are currently being pursued.

  • Regulatory Oversight On Gene Therapy In The U.S. And EU
    Regulatory Oversight On Gene Therapy In The U.S. And EU

    Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

  • Planning A Gene Therapy Trial? Ask An Expert — And Pay Attention
    Planning A Gene Therapy Trial? Ask An Expert — And Pay Attention

    Whether the experts come from a CRO or a regulatory consultancy, their help will be critical in helping develop the trial, meet with the Institutional Biosafety Committee, establish a timeline, and manage expectations. Here’s why.

  • Rare Disease: Operationalizing Gene Therapy Trials
    Rare Disease: Operationalizing Gene Therapy Trials

    Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed is the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.

  • Principles Of CAR T Cell Therapy And The Pathway To Regulatory Approval
    Principles Of CAR T Cell Therapy And The Pathway To Regulatory Approval

    Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as “CARs”. The CAR enables the final product to produce chemicals in the hopes that the “enhanced” product or cells will bind to the cancer cells and kill them. In this free webinar, learn about the principles of CAR T cell therapy and the ways these technologies can reach patients.

  • Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research
    Registry And Natural History Studies: Vital, Contrasting Roles In Rare Disease Clinical Research

    Both registry studies and natural history studies play important roles in rare disease research. Understanding the differences between the two types of studies and how they can be used to inform clinical development can help sponsors plan for success.

  • Complete Response: Lymphoma Trial A Success For Five Patients
    Complete Response: Lymphoma Trial A Success For Five Patients

    A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma overcame patient recruiting challenges and has already succeeded beyond expectations in the form of five patients declared disease-free a year and counting while still three years from completing patient follow-up.

  • A Primer On Cancer Immunotherapy
    A Primer On Cancer Immunotherapy

    Widespread use of immune checkpoint therapy to treat cancers is hampered by unpredictable response rates and immune-related adverse events. To address these challenges, combination therapies are increasingly being studied as a strategy for improving response and overcoming resistance. In this post, we provide an introduction to cancer immunotherapy, exploring its immunological basis and the fundamental principles guiding development of new treatments.

  • A Brief Introduction To CAR T-Cell Therapy
    A Brief Introduction To CAR T-Cell Therapy

    With the approvals of tisagenlecleucel (KYMRIAH™) and axicabtagene ciloleucel (YESCARTA™) last year, chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. This blog breaks down the development of CAR-T cell therapy as well as its advantages and challenges.

  • Six Issues To Consider For Rare Disease Pre-IND Meetings
    Six Issues To Consider For Rare Disease Pre-IND Meetings

    Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. By proactively preparing for this meeting, sponsors can set themselves up for productive discussions which may help in identifying areas of regulatory flexibility.

  • 5 Operational Considerations For Rare Disease Trials
    5 Operational Considerations For Rare Disease Trials

    From researchers to sponsors to patients to advocacy groups to clinicians, in rare disease research all people involved must be utilized to their greatest potential for a study to be successful. Learn more about the operational challenges within rare disease research and how to overcome them.

  • The FDA’s New Guidance On Natural History Studies In Rare Diseases: What You Need To Know
    The FDA’s New Guidance On Natural History Studies In Rare Diseases: What You Need To Know

    In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases that addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lack of natural history data to guide the design of successful clinical trials. Read more to learn about the important role natural history studies play in drug development and their benefits.

  • Data Protection Part 1: Understanding How GDPR Affects Clinical Trials
    Data Protection Part 1: Understanding How GDPR Affects Clinical Trials

    Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, including clinical research. GDPR contains a number of articles that present unique challenges to the pharmaceutical clinical trials industry. In this blog series, we focus on defining the regulation, on key aspects of GDPR that are relevant to clinical trial professionals, and on providing insight on how CROs can achieve compliance in data handling throughout the clinical trial process.

  • Investigational New Drug Applications: Five Solutions To Common Problems
    Investigational New Drug Applications: Five Solutions To Common Problems

    There are many pitfalls that come with preparing an Investigational New Drug (IND) application for FDA submission, but with the right plan – and the right partner – there are also plenty of ways to avoid them. Here are five actionable steps can help ensure your next IND is a successful one:

  • Investigational New Drug Applications: Four Common Mistakes
    Investigational New Drug Applications: Four Common Mistakes

    Before starting Phase I trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. Here are the most common errors we’ve seen made with IND submissions.

  • When Other CROs Said No, We Said Yes — To The Nearly Impossible
    When Other CROs Said No, We Said Yes — To The Nearly Impossible

    The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

  • Improving Regulatory And Operational Performance In Orphan Drug Development
    Improving Regulatory And Operational Performance In Orphan Drug Development

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

  • Premier Research To Sponsor BIO International In June 2019

    Premier Research is proud to sponsor this year’s BIO International Convention June 3-6, 2019 in Philadelphia, PA. As a co-sponsor of the Orphan & Rare Disease session track, we look forward to continuing the conversation about how far we’ve come in the treatment of these unmet needs through addressing knowledge gaps, innovative trial designs, and conversations with patients — and the work that still needs to be done.

  • Untapped Potential: Asia-Pacific’s Growing Role In Biotech Drug Research
    Untapped Potential: Asia-Pacific’s Growing Role In Biotech Drug Research

    For all its demographic promise, the Asia-Pacific (APAC) region has been slow to emerge as a center for US and EU biotech clinical drug research. Patient access in this region is now a strong motivator. Read further observations about the future of the APAC region in biotech drug research.

  • Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
    Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar

    In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.

  • CAR T Cell Therapy And Other Technologies Emerging In Oncology Research
    CAR T Cell Therapy And Other Technologies Emerging In Oncology Research

    Some unique CAR T cell therapies have already been approved by the US Food and Drug Administration (FDA) and are the first steps toward further groundbreaking science. In this webinar, Emile Youssef, Premier Research’s Executive Medical Director, reviews the operational and clinical pathways that are helping to bring these technologies to patients.

  • Boosting Immuno-Oncology’s Effectiveness Against Cancer
    Boosting Immuno-Oncology’s Effectiveness Against Cancer

    The current limitations on the use of immunotherapy drugs could be swept away thanks to the development of immune checkpoint inhibitors. They block disruptive proteins that limit the body’s natural immune response and stop T-Cells from destroying cancer cells. Some of the biggest factors stopping the more widespread use of these drugs are the limitations of current standards in effectively measuring how well they work. Read how improvements in the methods used for immuno-oncology drug trials could benefit both researchers and patients.

  • Premier Research Champions Patient Advocacy Community

    As part of its commitment to supporting the patient advocacy community and as a kickoff to Rare Disease Day on February 28 and March as Rare Disease Month, clinical research company Premier Research is announcing both a new scholarship for rare disease patient advocates in partnership with Professional Patient Advocates in Life Sciences (PPALS) and the launch of a new Patient and Stakeholder Engagement (PASE) capability led by Juliet Moritz.

  • The Placebo Problem In Pain Research Keeping Up With The ‘Mrs Joneses’
    The Placebo Problem In Pain Research Keeping Up With The ‘Mrs Joneses’

    Pain trials are uniquely challenging because they rely so heavily on patients’ own assessments. While researchers will always need to account for the placebo effect when studying indications as subjective as neuropathic pain, there are ways to increase the likelihood of achieving objective trial outcomes.

  • It’s About How The Social System Works, Not Just The Science
    It’s About How The Social System Works, Not Just The Science

    After a failed attempt from their first CRO, this manufacturer turned to Premier Research to successfully recruit and retain 24 patients for a Phase I proof-of-concept study of inflammatory bowel disease.

  • A Strategic Partner, Or A Vendor Looking To You For The Answers?
    A Strategic Partner, Or A Vendor Looking To You For The Answers?

    Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.

  • 6 Early Phase Dose-Finding Trial Designs For Oncology Therapeutics
    6 Early Phase Dose-Finding Trial Designs For Oncology Therapeutics

    The optimal dose-finding strategy for a given therapeutic agent and indication is based on a multitude of factors, accentuating the need for individual tailoring in oncology drug trial design. Read on for a look at six of the most common dose-finding trial designs in oncology today.

  • Ethical Considerations In Adaptive Design Clinical Trials
    Ethical Considerations In Adaptive Design Clinical Trials

    While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.

  • 5 Must-Dos To Build Trust Between An Early-Stage Biotech And CRO

    Take these steps to create a trusted partnership with your CRO and achieving a much more accurate and financially workable CRO agreement.

  • CAR-T Cell Therapies: Safety Considerations and Toxicity Management
    CAR-T Cell Therapies: Safety Considerations and Toxicity Management

    Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

  • 4 Potential Advantages Of Adaptive Design
    4 Potential Advantages Of Adaptive Design

    Adaptive design strategies have been especially useful for rare disease research in general and rare oncology in particular. Read more to see how the savvy application of adaptive trial design compares to conventional study designs.

  • 5 Endpoints For Rare Oncology Trials
    5 Endpoints For Rare Oncology Trials

    For patients battling rare cancers, especially those lacking standard treatments, they don’t have the time to wait for more concrete measures. In these cases, choosing the appropriate endpoint for a trial is crucial. Read on for a rundown of the five major types of clinical endpoints in rare oncology and the best way to use them.

  • From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments
    From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments

    This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.

  • Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
    Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

    This webinar highlights the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process.

  • Immuno-Gene Therapeutics In Hematological Cancers: How Science Drives Study Strategy
    Immuno-Gene Therapeutics In Hematological Cancers: How Science Drives Study Strategy

    This webinar reviews the current state of technology in gene therapeutics and examines trends in immuno-oncology and gene therapy for hematological malignancies.

  • The Complex Issues With Developing A Novel Human Antibody From Scratch
    The Complex Issues With Developing A Novel Human Antibody From Scratch

    Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.

  • Overcoming The Challenge Of Enrolling Sickle Cell Patients In Clinical Trials
    Overcoming The Challenge Of Enrolling Sickle Cell Patients In Clinical Trials

    Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.

  • Recruiting Hard-To-Find Patients From A Specific HLA Subgroup
    Recruiting Hard-To-Find Patients From A Specific HLA Subgroup

    CRO helps company overcome early patient screening failure rate of 70 percent as well as assisting with instituting new protocols and renegotiating contracts as the study experiences and major change of direction.

  • Lengthy Cancer Drug Study Using Dozens Of Sites Yields Positive Results
    Lengthy Cancer Drug Study Using Dozens Of Sites Yields Positive Results

    After lengthy recruiting process and a five year long clinical trial spread across more than two dozen sites, sponsor calls study results “an unexpectedly huge step forward” in overcoming the limited efficacy of current treatments and continues partnership with CRO.

  • CRO Helps To Identify A Highly Productive Location For Siting Future Studies
    CRO Helps To Identify A Highly Productive Location For Siting Future Studies

    Compromised data collection effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about the need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.

  • Five Things To Know When it Comes To iRECIST
    Five Things To Know When it Comes To iRECIST

    Here are five things you should know about iRECIST as the standard shapes up as an important tool in assessing solid tumors.

  • Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents
    Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents

    Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.

  • Rapid Change, Real Promise: The Future Of Rare Oncology Research
    Rapid Change, Real Promise: The Future Of Rare Oncology Research

    Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

  • Six Dosing And Safety Considerations In The Era Of Emerging Therapies
    Six Dosing And Safety Considerations In The Era Of Emerging Therapies

    Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies.

  • Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
    Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

    Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

  • Opportunities Beyond Hope: Immuno-Oncology Drug Development
    Opportunities Beyond Hope: Immuno-Oncology Drug Development

    Explore the role of the immune system in cancer development, as well as the history and challenges of developing immunotherapies for cancer.