Industry News: New Study Shows DCT Methods Helped Lung Cancer Trial Enrollment as COVID Surged

Remote and flexible trial approaches have been a hallmark of clinical trials during the pandemic and are widely believed to have been the primary factor in keeping trials open and operating. There is evidence showing that such measures as telehealth visits, off-site diagnostic/monitoring procedures and remote consenting were at least partially responsible for the ability of lung cancer trials to weather the storm.

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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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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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Clinical Trials Monthly Case Study Analysis

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question this month it’s a look at SAFETY and ADVERSE EVENTS and the value of an electronic, real-time reporting system.

The Scenario: Criterium conducted a multi-center study across continents that required time-sensitive safety review but posed the challenge of a 7-hour time difference.

We asked ourselves:
What If: We could program our in-house EDC to provide real-time data in order to review safety information on an ongoing basis and make important study decisions; the absence of which would significantly impact safety and the overall project goals.

Criterium Patient Profile Reporting: The PatientProFileTM

  • In 2006, Criterium developed the PatientProFileTM reporting system to provide real-time information to our New York data center from our South African clinical operations office where enrollment was ongoing.
  • By integrating required safety data into a PatientProFileTM reporting system, we allowed for important medical safety review without having to take the significant 7-hour time difference into account and improved the Data Management process.
  • The PatientProFileTM reporting system connected two continents participating in a single clinical trial. As of 2013, the PatientProFileTM reporting system is used in all our clinical trials, USA-based and Global.

Patient Safety and Reporting

The PatientProFileTM reporting system produces individual reports for clinical trials, integrating data such as Demographic, Laboratory Results, Adverse and Serious Adverse Events into simple, real-time reports that can be reviewed as data is entered on an ongoing basis from any web-based computer.

The benefits of the PatientProFileTM reporting system are many and include, but are not limited to:
– Provision of data to Data Safety Monitoring Board(s)
– Review of data for interim analysis
– Provision of adverse event trending information
– Abstract/manuscript preparation
– Go/N-Go decisions

Our Result: The PatientProFileTM reporting system allowed the sponsor to make important safety decisions and necessary changes to the study design that provided scientifically valid data and protected the safety of all trial participants.

Got Questions? We have Answers! Contact us at

Q&A with Greg Bailey: IVR vs IWR ? Which is Best for YOUR Needs?

Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries
Greg Bailey Knows IVR IWR EDC ePRO Patient Diaries

1.???????It?s like alphabet soup ? what do all the initials mean?

  • IVRS is Interactive Voice Response System ? this is what is usually referred to as voice menus (?Press 1 for this, Press 2 for that?), and we use those functions to allow patients to input detailed answers to trial-related survey questions.
  • IWRS is Interactive Web-based (or Web-board) Reporting System? this is the part of the system that the trial site and the sponsor use to see the results of patient input
  • ePRO ? Electronic Patient Reported Outcomes ? uses? IVR and IWR to capture and report all this trial data from patients
  • EDC is Electronic Data Capture, or another way to describe the IVR-IWR system as a whole

2.???????How do you implement IVR systems for a trial?

  • Criterium hosts our IVR applications in Boca Raton, Florida.? We contract with a toll free forwarding company to take international calls and forward them to the Florida Data Center.? This means we are able to provide a local number anywhere on the Globe that is then transferred to Florida. Once the application is moved into a production environment the focus of technical support is making sure the IVR will pick up when called.
  • The system manager in Florida utilizes automated monitoring software in conjunction with manual testing of the production applications.? Someone on the study team will be trained and involved throughout the development, testing and deployment process so they will have a good understanding of the application as a whole.? That will allow the project member to respond quickly to questions from the client.

3.???????Have IVRS systems replaced IWRS systems — or vice versa?

  • No, the IVRS and IWRS systems are built to complement each other.? Both systems access the same database so they are really just two portals into the same information.
  • IVRS is better suited for situations where there is limited internet access or the type of information being collected is minimal and concise, such as patient diaries, patient registration or randomization.
  • IWRS is better suited for reporting and entering textual information, such as comments, and where internet access is stable.
  • The IWRS can do anything the IVRS can do, while the IVRS is limited to what can be entered via telephone keypad entries.

4.???????Does Criterium have its own servers?

  • Yes, we have our own servers and all necessary equipment to handle large volumes of phone calls and web applications.? We have a strong investment in the infrastructure.? We have redundant internet and phone circuits as well as servers.? Our server room has backup power supply and is in a very secure location.

5.???????Which is most cost effective ? IVR or IWR?

  • That depends on the application.? Usually the IWRS is built first to allow administrative functions (site maintenance, login maintenance, reporting, and more) and then the IVR registration / randomization of subjects is added.? Since it is tailored to every specific trial?s requirements, it?s easier to say that it?s a real-time data advantage that you can?t afford NOT to have!

Read more about EDC from Greg Bailey:


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The Advantages of Translational Research Methodology

Applying basic research knowledge to practical applications is a well-known obstacle to?progress?in science. This issue is seen most often in medical science. There is often a lag between emerging scientific findings and their application as treatments to patients who may benefit from them.Translational research is aimed at taking basic science? research to the next level.?It connects new discoveries to application in patients.

Multidisciplinary Collaboration
There are four basic steps to consider in this research tactic.

  • Development of techniques to translate new knowledge generated in a lab environment, or at the bench level, to human testing
  • Refinement of human study results for? clinical use
  • Transference of practices from academic medical centers to use in the care of patients in community practice
  • Continued evaluation of data from the previous steps to provide confirmation of the efficacy and tolerability of new therapies

The goal of translational research is to quicken the transition from the lab to the patients who may benefit from the basic science findings. Thus translational research is a collaborative effort among basic researchers, academic physicians and community health professionals to provide new treatments to appropriate patient populations.

Funding Options
Translational research can potentially expand the funding options for a project.

  • Researchers benefit by working with a center that is able to provide seed funding. They reduce overall project costs by utilizing basic science center personnel for development of new therapies that then can be applied to patients in the community..
  • For universities, setting up a translational research center is a tactical approach to improving funding options. Through the research center, academic organizations develop strategic plans to provide improvements in public health benefitting overall community.
  • Communities benefit by gaining a stake in the study. The community becomes a contributing member of innovative medical research.

Stoking Excitement in a Field of Study
The developing barriers between research and clinical applications tend to dim interest in research projects. Moving towards a translational approach expands these possibilities. The power to take new knowledge from the bench to a clinic setting and then back to the bench for analysis lifts some of the impediments to expanding interest in a project.

Translational Science Research

Physicians in the community are able to see
basic research translated into practical application. A project that was once unapproachable due to time constraints and the complexity of the study boundaries will now draw interest and participation.

Translational research is a bench-to-bedside approach to medical developments. With this two-fold methodology, basic science presents tools to clinicians that have the potential to improve patient care. Clinicians are able to make observations and provide valuable feedback about the progression of disease that will lead to more discoveries. A translational model benefits the community by speeding the application of new research findings to patients and thus drives the clinical research progress at a quicker pace.

The Oncology Consortia of Criterium believes this methodology is the best way to speed results of research to benefit the public – it’s why we say we are “Changing the Way Cancer is Managed”.? Read more about our approach at the Academic GI Cancer Consortium or at the Academic Myeloma Consortia web pages.

Got Questions? We have Answers! Contact us at

Claire WyntersThu, 11 Apr 2013 15:07:00 GMT

Quick Takes: the Pharma C-Suite with Mary Stefanzick, Data & Operations Director



?The Evolution of the CDL?- The Clinical Data Liaison

The CDL is a role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money.?Criterium has been utilizing the efficiencies of the CDL position since 2001. It is a successful tool we use to streamline our clinical trials.

The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager.? The best of both worlds.?

Within any CRO, a CDL is the link to a successful clinical trial. ?This individual has the ability to influence the three Cs of site management: connect, communicate, and control. This position is key in that he or she conducts real-time data review and facilitates centralized control of data management.?

To really improve the workflow process, the CDL is a clinical and data expert who connects team members ? sites, CRAs, and data managers ? through the use of data collection technologies that are used in a workflow that emphasizes real-time receipt and review. The ultimate benefit of the workflow that is managed through the CDL is to reduce the barriers between monitoring and data management.

Three of the most important reasons to utilize CDL?s in your study:?

The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager. As such, CDL’s are the first to review CRF’s to make sure that the protocol is being followed.?

They are responsible for timely review of data safety values, such as SAE’s, AE’s, lab values, and ECG’s that are critical to the safety of the patients; they do this in the context of the overall database. This is especially important, as the field monitor?s perspective is based on the review of individual site visits.

cdl chart for blog

Because CDL’s monitor site data daily, they are able to identify potential problems before they arise thereby reducing the cost of field monitoring per patient by as much as half when compared with traditional monitoring.

Find out more about this efficient and cost-effective method of trial management:




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Claire WyntersThu, 28 Mar 2013 20:33:00 GMT