Central Laboratories Applications & Studies

91. 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.

92. 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.

93. 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.

94. 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.

95. 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.

96. 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.

97. 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.

98. The Complex Issues With Developing A Novel Human Antibody From Scratch 12/26/2018

    Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.

99. Lengthy Cancer Drug Study Using Dozens Of Sites Yields Positive Results 12/26/2018

    After lengthy recruiting process and a five year long clinical trial spread across more than two dozen sites, sponsor calls study results “an unexpectedly huge step forward” in overcoming the limited efficacy of current treatments and continues partnership with CRO.

100. CRO Helps To Identify A Highly Productive Location For Siting Future Studies 12/26/2018

     Compromised data collection effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about the need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.