Central Laboratories Applications & Studies

81. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

    Travere Therapeutics is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

82. A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH) 8/5/2020

    Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.

83. Key To A Faster, More Flexible Clinical Trial Process 7/24/2020

    Discover how a single, integrated data analytics and visualization platform, supported by an experienced partner, can help you move your investigational product to market more quickly.

84. Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial 5/4/2020

    A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

85. Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS 3/6/2020

    Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.

86. Cleaning Up Patient Data … Quickly 3/2/2020

    A sponsor needed to deliver data so 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. We picked up the project in March 2013 and completed data lock by the end of September.

87. Getting Creative: A Hybrid Answer When The Conventional Won't Do 3/2/2020

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

88. Clinical Development Challenge - Use Of RWA To Understand Natural History 2/26/2020

    A biotechnology company without an in-house real-world evidence team did not have the adequate resources, connections, or expertise available to conduct a natural history study of the rare, oncology indication for which they were developing a new therapy. Their solution was found in a virtual real-world evidence department.

89. Getting Every Detail Right – With No Time To Think About How 2/21/2020

    With a customer racing to beat a competitor to registration with last patient out to database lock in two weeks, this CRO was able to step in and take charge and the study was completed on schedule.

90. Back On Track: Data Rescue On Pediatric Rare Disease Trial 2/3/2020

    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. Premier Research was able to step in and successfully take over the data management and statistics portion of the trial to keep the trial on track.