Depending upon the requirements of a particular clinical trial, our ECG and Imaging Core Labs offers additional services on an as needed basis. Our additional services that are utilized most frequently include:
Trial Design
Our core labs provide services for protocol development and trial design. Our thought leaders provide clinical input services for a historical review, compound evaluation, study design and structure, protocol drafting oversight, and assistance with protocol revisions. Our medical writers provide services for annotated literature reviews, protocol drafts, and protocol revisions. Our statisticians can provide services for protocol-specific statistical components, oversight of protocol drafting, and assistance with protocol revisions. Trial design services can be supplied singularly or in conjunction with core lab study services.
Clinical Events Classification (CEC)
Our core labs work with the CEC group to find ways to improve clinical trial methodology. Some of the activities in which CEC is involved include development of endpoint definitions, case report form pages for endpoint events, and adjudication forms for endpoint results. Other CEC services include even packet preparation, collection of source documents from sites, development of tracking databases and status reports, data entry of endpoint results, and clinician services for event adjudication. CEC is able to provide unbiased assessment of clinical trial endpoints by operating independently of core lab personnel. As a result, CEC assessments are critically influential in determining event rates in clinical trials.
Imaging Review Charter
For imaging trials, our Imaging Core Laboratory can supply a study-specific imaging review charter for FDA submission. An imaging charter is a supportive document for the imaging protocol. Specifically, an imaging charter outlines how the imaging protocol will be executed by explaining how reading interpretations will be implemented, how study readers are qualified, how study readers will be trained, and how reading criteria requirements will be met. Imaging charters are documents that are descriptive of processes. They are created in an effort to ensure consistency and reliability through formative, documented standards. Imaging charters often serve as a validation tool for their associated study protocol.
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