Central Laboratories Applications & Studies

81. 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.

82. 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.

83. 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.

84. 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.

85. 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.

86. 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.

87. Scaling A Solid Tumor Study 1/2/2020

    As a result of positive treatment outcomes during a Phase Ib/II multicenter oncology program, patients continued in the trial for significantly longer than expected, creating a large data backlog that required source document verification. Read how strategies were deployed to obtain data currency and add management oversight to meet the program's expansion.

88. Advancing Oncology Development With A Synthetic Control Arm Trial 8/7/2019

    A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.

89. Predictive Biomarker Signature Characterization 8/7/2019

    A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.

90. Data Standardization For Late Stage Development And Periapproval Studies 7/10/2019

    Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.