December 7th – 8th , 2021 La Jolla, CA Booth 36 Visit Premier Research at Booth 36 at Outsourcing in Clinical Trials (OCT) Southern California to discuss the common challenges and trends impacting the region such as COVID, steps for defining contractual relationships and getting the maximum from external providers, incentivizing good relationships with CROs...
Morrisville, N.C., September 13, 2021 — Health Decisions, A Division of Premier Research, will support the Women’s Health Innovation Summit as an Associate Partner for the third year. On Tuesday, September 14 from 12:10 p.m. to 12: 45 p.m. EDT, Health Decisions, an organization that provides clinical research specific to women’s health, will present a...
November 9th – 10th, 2021 Boston, MA Booth 69 Visit Premier Research at Booth 69 at Outsourcing in Clinical Trials (OCT) New England to discuss the common challenges and trends impacting the region such as COVID, steps for defining contractual relationships and getting the maximum from external providers, incentivizing good relationships with CROs and constructing...
In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are...
Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the...
The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...
Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized...
Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...