Monthly Archives: March 2019

DURHAM, N.C., March 25, 2019 — Premier Research’s head of patient engagement will discuss a patient-centered look at drug development at the World Orphan Drug Congress (WODC) USA in Oxon Hill, Maryland. Juliet Moritz, Premier Research’s newly appointed vice president of patient and stakeholder engagement (PASE), will present From the End to the Beginning: A Patient-CentricRead more

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence ofRead more

DURHAM, N.C., March 19, 2019 — Chimeric antigen receptor (CAR) T-cell therapy shows enormous potential for treating many forms of cancer, including lymphoma, acute myeloid leukemia, and myelodysplastic syndromes. Oncology experts Brian Marks, BSc, DC, Senior Director and Ashley Jones, MSc, Project Lead will discuss these emerging therapies and their potential to unleash the body’s defensesRead more

With the advent of the EU’s General Data Protection Regulation, individuals now have expanded rights to information regarding the use of their personal data. These changes impact several aspects of the clinical trial recruitment process and may require sponsors and CROs to update their data collection and protection protocols and processes for informed consent. ConsentRead more

DURHAM, N.C., March 8, 2019 — Premier Research has added key expertise to its global CRO operations by naming three new medical device and diagnostics specialists. Joining Premier Research are Vicki Gashwiler as executive director of clinical development services, medical device and diagnostics; and Sundeep Shrivastava as executive director of clinical development services, medical deviceRead more

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 theRead more

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy noticeRead more

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