INSIGHTS ON CLINICAL TRIAL PARTNERING

• The Power Of More: Re-Imagining The Traditional Business Model For Oncology Clinical Research

  Motivated oncology clinical research leaders are focusing on patient care, faster study starts, more patient access to trials, and better performance - while reducing costs and staffing burdens. How can you transform today's challenges into opportunities for your site? This on-demand webinar highlights industry trends for oncology research, as well as common obstacles and new approaches for greater success.

• Keep The Best Sites. Protect Patient Safety. Reduce The Safety Reporting Burden

  In a highly competitive market, some sponsors are alienating sites and investigators by wasting their time. To reduce the burden on sites, sponsors must rethink how they manage safety reporting. Doing so also improves patient safety and enhances compliance. This blog captures some of the salient points from a recent webinar where Elena Jouravleva, PhD, Director of Regulatory for US Oncology Network, and I discussed the ways safety reporting overburdens sites.

• Expedited Study Delivery - Pharmacy

  A biotech sponsor needed to conduct a challenging Phase I SAD/MAD study, involving multiple IV doses over multiple days in healthy volunteers. Read how our team not only delivered a complex study during a difficult recruitment time and meeting all study criteria but also gained a repeat customer.

• COVID-19 Changed Everything – Now Contracts & Budgets Need To Catch Up

  As clinical trials shift quickly and necessarily from in-person to hybrid trials, remote visits, and virtual experiences and support, new opportunities and challenges emerge. While the industry figures out how to best navigate these new challenges, and much remains unresolved, we do know this: Sites and sponsors will be recalibrating everything, especially contract terms and budgets for either new components of trials or changes to clinical research. Site budgets for ongoing studies will need to be recalculated, amended and renegotiated, and contracts and budgets for new studies will have new considerations.

• Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs

  7/20/2020

  Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which could lead to delays that create a market shortage that triggers serious health consequences for patients. A clinical supply partner can provide packaging as needed and handle distribution for expanded access and general commercial needs.

• Steps To Implementing A Quality Management System (QMS)

  8/9/2021

  Across the life science industry, many development companies and research and development (R&D) organizations do not have a quality department or even a specific quality function in their early stages of development. Read how science and research-driven activities require a high degree of flexibility and may demand fast reviews of development stages – at times, even reconsideration of the development program or project termination. 

• Delivering The Full Value Chain For Oncology Clinical Trials

  8/24/2021

  Oncology clinical trials are always challenging, and clinical approaches and the needs for supportive services continue to evolve. Partnering with the right contract services organization that is committed to putting patients first is critical.

• The Workforce Of The Future: CRAs

  3/10/2021

  Parexel FSPs, Lisa Feeley, Vice President, Clinical Operations, is joined by Jennifer Sheller, North America Regional Head, Global Clinical Trial Operations at Merck, to discuss how to prepare the CRA workforce for the future. 

• Increasing Site & Patient Convenience For Oncology Clinical Trials

  2/10/2021

  According to a recent ACSCAN report, out of all potential qualifying patients for a trial, only 44% of them have access to an available trial, only 27% are eligible for the trial, and only 8% are able to successfully enroll in a study. These are just the barriers leading up to trial participation. Once a patient is enrolled, there are many obstacles that can impact patient retention in a study. Let’s discuss some of the obstacles facing oncology research today and highlight innovation opportunities to transform the way sites, sponsors, and CROs interact.