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A Trial Master File (TMF) is a collection of all essential trial documentation that enables effective monitoring, data integrity, and compliance throughout the lifecycle of a clinical trial. Learn about best practices and approaches for Trial Master File management.
Continue readingEach month, we investigate a different Clinical Trial Case Study that posed us with a challenging question; this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:
We asked ourselves:
Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.
Criterium offered an integrated technology-enhanced solution that allowed the sites to register 
patients and allowed the patients to record their event data directly into our remote systems.
Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.
What If: If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.
Results: Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.
Read more of our successful case studies
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Criterium, Inc., a full-service CRO is proud to be the CRO of record as the supplier of services and support for this important trial. Further study details are provided by the pharmaceutical development sponsor, AtoxBio Ltd. on ClinicalTrials.gov
A complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online (http://archsurg.jamanetwork.com/article.aspx?articleid=1859986). This is a study to evaluate the safety and pharmacokinetics profile of different doses of AB-103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections. Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB-103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections.
The efficacy domains 
are:
Criterium, with extensive experience in dermatology and infectious disease indications, particularly with wound and burn treatments, provided services for data and project management, clinical and medical monitoring, biostatistics, safety, regulatory support, and medical writing.
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Clinical trials data management is essential for medical and clinical researchers, doctors who assist with pharmaceutical drug development and C-suite decision makers in pharmaceutical drug development. The “3-C’s” of site management include connection, communication, and control.
The value of real-time clinical trial data feedback lies in enabling these medical professionals to attend to each of those “C” actions. The real-time connection and communication allows pharmaceutical professionals to review incoming trial data in real-time and control its dissemination and implementation in order to support making critical business decisions mid-stream in a project.
Importance of Real-Time Clinical Trial Data Feedback
As professionals working in the ever-changing world of medical research, we know that outdated information is ineffective for making important decisions that are vital to safe health practices. When medical professionals make decisions during prescription drug development, those decisions can affect people’s well-being and even their lives. This is why clinical trials data management must facilitate and implement real-time clinical trial data feedback, to provide the most current information and best practices within pharmaceutical drug development.
Implementing Electronic Data Capture (EDC) as a key strategy for clinical trials data management of real-time clinical trial data feedback assists pharmaceutical professionals in several essential areas:
Consider This
Implementation of data standards for real-time information flow within clinical data management:
Overall, clinical trials data management of real-time clinical trial data feedback has proven to be the most positive and effective way to promote health and safety within the pharmaceutical development process.
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com