In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment. A Direct-to-Patient (DTP) model applies only to studies for which the sponsor has had…
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In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for development of new drugs and vaccines normally take years. In light of the situation, however,…
We’ve gathered questions from our customers and vendors regarding potential impact of COVID-19 on current and planned studies. Although we may not have answers for every situation, here are some areas that we are keenly focused on to support our sponsors: For more information on Premier’s capabilities, click here.
Oncology & Hematology
Considerations for Operationalizing Pediatric Oncology Studies
Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By closing the orphan drug exemption loophole and enabling earlier discussions with the FDA, the Research…
At Premier Research, we attend a lot of events throughout the year – and through these events, we have the opportunity to meet individuals from all sides of the clinical development process. At the recent Global Genes RARE Patient Advocacy Summit, we met countless patients, advocates, and their families, including Kim Tuminello and her daughter…
Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group recently issued the Medical Device and Health Information Technology (IT) Joint Security Plan (JSP). [1]…
Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. The approvals of voretigene neparvovec-rzyl (Luxturna) for inherited vision loss, tisagenlecleucel (Kymriah) for lymphoblastic leukemia, and axicabtagene ciloleucel (Yescarta) for lymphoma have ushered in a new era of therapeutics. With the rapid evolution of the…
Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront British…
When selecting a CRO partner, sponsors usually focus on organizational experience – how long the company has been in business, its areas of therapeutic expertise and the breadth and depth of its service offerings. But, sponsors sometimes forget to ask about specific team experience. What do you know about the core study team members –…
Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate clinical trial results. It’s as if the phrase “get it right the first time” had…