The Trial Master File 10 Essentials for Success

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.

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Clinical Trials Monthly Case Study Analysis: Cost Reductions / Hematology

Each 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 ePRO Patient Diaries Input-Output Diagrampatients 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

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A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections

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

Clincial Trial Results ReportA complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online ( 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 Lab-Beakersare:

  1. Clinical status domain
  2. Pharmacoeconomics domain
  3. Systemic and local inflammatory biomarker domain

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.

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Why Get Clinical Trial Data Feedback in Real-Time?

Real Time Data ManagementClinical 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:

  • Real-time immediate feedback: Allows for transfer of data in real-time; rapid resolution of discrepancies; reduction of time and costs; acceleration of query management; and verification and correction of inconsistencies in data in real-time.
  • Up-to-date accessibility of trial information and feedback: Allows for organization of global research data into a single database; provides up-to-date study statistics; enables less time to develop and produce essential statistical reports; and decreases risk of data blinding errors.
  • Safer, higher quality of data: Allows for encryption of data, which prevents any changes, deletions, or modifications; facilitates faster data cleaning processes; and automates editing and discrepancy checking.
  • Integrated safety data: Allows for crucial medical safety reviews regardless of data source’s originating country or time zone.
  • Adverse trends: Allows for tracking and reporting on adverse trends occurring with select pharmaceutical drugs.
  • Ongoing workflow: Allows for workflow to continue on an ongoing basis with real-time data, integrating and updating information as it is received.
  • Cost reduction: Allows more cost-effective means to share and store data, feedback, and other relevant clinical trials information; reduces the number of necessary field monitoring on-site visits; reduces clinical research costs; and reduces cost of introducing new drugs to the pharmaceutical market.

Consider ThisData Stream
Implementation of data standards for real-time information flow within clinical data management:

  • improves efficiency of trials and their relevant feedback;
  • allows for maximum usability of tools
  • enables combining data across clinical studies
  • facilitates collaboration across departments and organizations
  • promotes easier and more effective implementation of the three “C’s” of site management by connecting authorized parties to real-time clinical?trial data, communicating clinical trial data, and controlling the safety of clinical trial data and its related feedback.

EDC ButtonOverall, 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.

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