Newsletter | June 8, 2021

06.08.21 -- 3 Keys To Implementing A Successful Decentralized Clinical Trial

Compensating For The Unknown: 3 Keys To Implementing A Successful Decentralized Clinical Trial

While the shift to decentralized clinical trials (DCTs) is well underway, concerns remain around patient monitoring and engagement as well as data reliability and quality. This article presents three takeaways gleaned from experience in designing and implementing DCTs in order to help protect patient safety and preserve data quality.

Pursuing Parkinson’s Disease Gene Therapies: Strategies And Operational Requirements

While treatment of Parkinson’s disease has traditionally been limited to dopamine replacement therapy to alleviate symptoms, gene therapy studies have recently evaluated both non-disease-modifying and disease-modifying transgenes for Parkinson’s disease (PD) treatment, with encouraging results. Conducting these trials requires careful attention to investigator and site selection and adherence to local regulatory and protocol design requirements.

Site Selection, Manufacturing, And Long-Term Follow-Up: Looming Challenges For A Rescue Phase 1/2 Gene Therapy Trial

Designing and conducting a gene therapy trial is a complex undertaking. Understanding, planning for, and overcoming the myriad challenges of operationalizing these studies will help you bring safe, breakthrough treatments to patients with unmet medical needs. This case study serves as a framework for exploring critical study design considerations of gene therapy trials and offers strategies for addressing those hurdles.

The Emerging Biotech’s Guide To Creating Scalable Infrastructure With A Functional Service Provider

For a biotech company, sudden growth can come in many forms. When your company finds it necessary to scale quickly while still maintaining complete oversight over every aspect of your study, partnering with a functional service provider (FSP) may be an excellent solution. Learn how a FSP can provide the expertise and instant infrastructure to move things ahead quickly while still retaining complete control.

Market Application And Lifecycle Management: The Road To Commercial Success

Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your trial strategy?