Partnering & Outsourcing Editorial

  1. Overcome The Challenges Of An Ultra-Rare Disease Trial

    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.

  2. Want To Partner With Big Pharma? Take This Expert Advice

    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.

  3. Clinical Trial Consortium Aims To Eliminate Inefficiency

    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.

  4. A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes

    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.

  5. 5 Major Challenges In CRO Outsourcing — And How To Overcome Them

    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.

  6. How 1 Drug, 2 Trials, And 2 CROs Might Transform Birth Control

    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.

  7. Monitoring Adverse Event Reporting On Social Media — Should You Outsource?

    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.

  8. Clinical Outsourcing Models: Still A Lot Of Churn And Uncertainty

    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.

  9. CRO Outsourcing — How To Optimize Your Selection Process

    This is part 2 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.

  10. Better Site Communication Means Better Trials

    But what best practices can you employ to ensure you and your site personnel are seeing eye-to-eye? Carrie Melvin, VP of Global Clinical Operations at TESARO, addressed the topic at the 2018 Clinical Leader Forum in Philadelphia. Proper communication will help ensure monitors are properly trained, protocol deviations are prevented, and data is collected timely and accurately.