INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Site Selection, Manufacturing, & Long-Term Follow-Up In A Transition Phase 1/2 Gene Therapy Trial

  Designing and conducting a gene therapy trial is a complex undertaking. Understanding, planning for, and overcoming the myriad of challenges of operationalizing these studies will help you bring safe, breakthrough treatments to patients with unmet medical needs.

• How To Mitigate The Placebo Response In Analgesia Clinical Trials

  The placebo effect can be problematic in analgesia clinical trials with a symptom-based approach, as placebo-related analgesic responses may occur and persist for some time in up to 60 percent of study participants. Here, we explore how trial designs and training programs may be used to help reduce the placebo effect in analgesia clinical trials.

• Essential Strategies For Patient-Focused Dermatology Clinical Trials

  Dermatology clinical research is undergoing a rapid transformation in response to new demands for clinical trials that are more justifiable, safer, and less burdensome for patients. In dermatology, a patient-focused approach can be applied to all phases of the research process. In this blog post, we explore a strategic, patient-focused approach to planning and implementing dermatology clinical trials.

• The Great Debate: The Use Of Placebo Control In Chronic Pain Studies

  The use of placebo control in clinical trials has long been a topic of spirited debate. In analgesia studies, the question of whether or not to use placebo control is further complicated by the placebo response, which can make it difficult to detect efficacy signals. In this blog, our industry-leading analgesia experts take a fresh look at the key considerations surrounding the use of placebo control in chronic pain studies.

• Global FSP: The Expertise You Need. Exactly Where You Need It.

  In the normal course of a clinical trial, delays are often accepted as part of the process. For instance, data entered by the site may not auto-encode correctly and therefore require further review by a medical coder, generally within five days. Under an FSP model, you gain access to a dedicated corps of experts that works alongside your study teams to deliver long-term support for key functions and meet project-specific needs. Read more about the critical advantages global FSO resources offer.

• Optimizing Site Readiness in Cell Therapy Clinical Trials Through Comprehensive Support

  Providing comprehensive support to sites is a critical factor for cell therapy clinical trial success. 

• Establishing Competitive Advantage In Dermatology Trials: Critical Study Design And Operational Considerations For A New Age

  In a new and extremely competitive era, there is more pressure than ever to optimize your clinical development strategy and planning for successful study recruitment, retention, and implementation. In this blog post, based on our recent webinar, we explore critical study design and operational success factors for this new wave of dermatology clinical trials.

• Site Selection, Manufacturing & 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. Here we introduce a case study as a framework for exploring critical study design considerations of gene therapy trials and offering strategies for addressing those hurdles.

• Navigating The Cost And Time Of Cell Therapy Manufacturing Process Automation

  Cell therapy process automation can deliver many benefits for product developers, including reduced risk of contamination, improved consistency of product and reduced cost of production. In this article, we discuss available devices and technology developments for cell therapy products in preclinical, clinical and early commercialization phases.

• How Single-Use Technology Will Be Critical To The Commercialization Of Cell And Gene Therapies

  Scaling up cell and gene therapies from research and development to commercialization is creating a new set of challenges for manufacturers. This article will demonstrate how adopting innovative single-use solutions for in-process sampling can have a tremendous effect in efficiency and effectiveness to the workflow.