Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.
As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”
ArQule is a personalized medicine company working in the oncology space to develop treatments that target specific mutations. While attempting to overcome a challenge with its product, ArQule was approached by a group at the NIH which wanted to partner to help patients with an ultra-rare disease known as Proteus syndrome.
When preparing for a large Phase 3 trial, many small companies may need a Big Pharma partner to help them through the process. But how do you connect with large companies? And what are the best practices for working with them? A panel at the 2018 Clinical Leader Forum in Philadelphia attempted to bring some clarity to those questions.
On March 1, 2018, the Partners in Innovation, Education, and Research Consortium™ (PIER) became an LLC in the State of Delaware. The six founding members of PIER (Jefferson Health, Atlantic Health System, Drexel University, Einstein Healthcare Network, Geisinger Health System, and Main Line Health) hope to bring efficiencies and cost reductions to clinical research.
This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.
This is part 3 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.
Poll results show that 24 million sexually active American women (55 percent) currently use no birth control method, yet these women have an 85 percent risk of becoming pregnant within one year. Additionally, of those American women who use birth control, about 8 million1 (36 percent) would prefer non-hormonal birth control. If successful in two clinical trials, Evofem’s Amphora product could transform birth control.
The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.
ISR Reports recently published the third edition of its Clinical Development Outsourcing Models report. I spoke to Andrew Schafer, president at ISR Reports, about the report, what we can learn from the responses, and what we can expect to see in clinical outsourcing models moving forward.
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