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 full-service 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 with a proprietary analytical platform to discover insights faster.
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
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, especiall 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.
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.
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.
This webinar reviews the current state of technology in gene therapeutics and examines trends in immuno-oncology and gene therapy for hematological malignancies.
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.
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.
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.
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.
Failure to transmit data collected effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.
Here are five things you should know about iRECIST as the standard shapes up as an important tool in assessing solid tumors.
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.
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.
Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies.
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.
Explore the role of the immune system in cancer development, as well as the history and challenges of developing immunotherapies for cancer.