Central Laboratories Applications & Studies

91. 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.

92. 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.

93. 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.

94. 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.

95. 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.

96. 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.

97. 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.

98. Small But Growing Biotech Manages Disclosure, Maintains Compliance, And Keeps Its Promise To Patients 4/11/2019

    For this biotech, the big challenge was both a lack of expertise and resources needed to manage registration of trials and posting results. TrialScope provided a proven solution that optimizes the efficiency of disclosure activities, maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.

99. Advancing A Diabetes Multi-Registration Program 3/11/2019

    A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.

100. Optimizing Protocol Design And Enhancing Patient Enrollment 3/8/2019

     An emerging biopharmaceutical company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment. Read how LabCorp de-identified clinical laboratory data helped evaluate the protocol feasibility and the overall design of the study while also making an adjustment in eligibility criteria was forecast to double the eligible patient pool – without impacting study endpoints.