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.
One Park Drive
Durham, NC 27709
Phone: + 1 910 447 3156
Contact: Karen Brown
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.
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:
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Take these steps to create a trusted partnership with your CRO and achieving a much more accurate and financially workable CRO agreement.
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.
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.
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.