Newsletter | March 12, 2020

03.12.20 -- Strategies For Emerging Biotech Studies

Involving Children, Adolescents, And Parents In Pediatric Drug Development

Actively seeking the involvement of pediatric patients and their parents throughout the life cycle of a clinical trial can help drive recruitment, retention, patient satisfaction, and, ultimately, the success of the study. This article discusses key factors that influence participation in pediatric clinical trials and presents strategies for encouraging clinical trial participation.

Back On Track: Data Rescue On Pediatric Rare Disease Trial

A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was not effectively managing the study data. As trouble mounted, the CRO quit, stranding the project at a critical point in the development cycle. Learn how the trial was able to stay on track by crossing the language barrier between a legacy data management system and a new data analysis platform.

Cleaning Up Patient Data ... Quickly

A sponsor needed to deliver data so that a go/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. 

A High Unmet Need That No One Wanted To Talk About

What do you do when patients are too embarrassed to talk about what’s wrong with them? Recruiting “hidden” patient groups for rare disease studies is always challenging, and flexibility is the only constant.

Getting Creative: A Hybrid Answer When The Conventional Won’t Do

A small oncology-focused biotech company presented a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.

Oncology and Hematology Drug Development

More than 65 percent of all our project managers/directors have hematology and oncology experience. Trial design, site selection, and recruitment, all tailored to the specific oncology indication. Premier Research. Built for Biotech.