Medical and Regulatory Affairs

Consulting

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. 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...

Medical and Regulatory Affairs

Premier Research Names New Medical Device Research And Regulatory Process Experts

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 device...

Global Compliance

Data Protection Part 2: Ensuring Study Start-Up Compliance With GDPR

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 notice...

Consulting

Planning For Quality In Your Medical Device Clinical Trials

The concept of risk-based monitoring (RBM) has been discussed, implemented and refined in the pharmaceutical and medical device worlds for more than a decade. Most large sponsor companies in the medical device industry have adopted RBM in their clinical trials. Meanwhile, smaller medical device companies, seem to be slower to embrace the concept. Despite years of conversation and availability of regulatory guidance from...

Data Management & Biostatistics

3 Key Takeaways on Choosing the Right Committee for Medical Device Trials

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency...

Medical and Regulatory Affairs

EU Medical Device Regulation: Your Questions Answered

With the European Union (EU)’s new Medical Device Regulation (MDR) taking effect in May 2020, device manufacturers transitioning to the EU MDR face a host of questions. Among them are: Is it possible to avoid compliance with the MDR? When should I be compliant? How will this affect my new product development? How does this affect my products currently on...

Medical and Regulatory Affairs

Brexit is Pressuring Sponsors. Here’s How We’re Responding.

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...

Clinical Research: Phase 1 - Phase 4

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. The objective of the GDPR is to strengthen and standardize the protection of personal data across the EU, including ex-EU data that is processed within the...

Medical and Regulatory Affairs

Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.

Consulting

The Engagement Gap: Bridging From Pre-clinical to First Patient In

Premier Research’s Chief Medical Officer discusses bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England in Boston. Topics include: – Early regulatory engagement and creating a sound development strategy – Assessment and hiring of key staff members: which positions to fill immediately and which can wait...