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.

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Clinical Trials Monthly Case Study Analysis


Each month, we take a look at a different Clinical Trial Case Study ? this month it?s a look inside an ALLERGY trial that focused on EXCEPTIONAL RESULTS:

The Scenario: Criterium provided an IVR patient diary solution to collect the pivotal efficacy data for an international clinical trial.

We asked ourselves😕 What if an after-the-fact paper patient diary could have been disastrous and could have necessitated the client repeating the study?

????????????? Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.

????????????? Through StudyControl?, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study.

Additionally, daily management of the site by Criterium?s knowledgeable staff members helped ensure that patient compliance among the additional study participants was at the highest level, thereby meeting the study?s control requirements.

Our Result: The statistical analysis exceeded the client?s expectations.

Creative thinking in designing clinical trials upfront is always the ideal, but it?s important to remember that there are factors and variables that can?t be accounted for during planning.? When we look at trials, we look at all the factors that surround the potential issues facing a trial ? technology can be a great tool to keep trials running smooth, but it’s the human factor that allows the technology to be a reliable component of the work.

Got Questions? We have Answers! Contact us at

Claire WyntersThu, 14 Mar 2013 16:21:00 GMT

Clinical Trials Monthly Case Study Analysis

SEPTEMBER Monthly Case Study Analysis:

Analyzing trial management through a different microscopeEach month, we look at a different Clinical Trial Case Study ? this month it?s a look inside a Phase II Dose Ranging Dermatology trial that focused on Regulatory Environment issues.

The Scenario: A Phase II NDA trial with 4 expert sites, in 4 countries enrolled 80 patients, in less than four months with outstanding clinical results.

We asked ourselves: What if the deadline for this product became critical? In principal, they needed to finish the study for their development partner before they completed the preclinical safety dossier.

The client decided to conduct this study outside of the US so they would not need to submit the study to the IND.? Our international field, data accession, and consultant team selected and managed 1 site each in Ecuador, New Zealand, South Africa and Sweden. The team enrolled the required number of patients in just 16 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final CSR (clinical study report) ahead of schedule.

Our Answer: Criterium saved more than three months and met the client?s deadline for corporate evaluation of the product.

Preparing clinical trials from financial issues upfront is always the ideal, but extension dates and changing timelines are variables that have to be accounted for in planning.? When we look at trial bids, we look at all the factors that surround the potential issues facing a trial ? location & timing can be tools to keep trials running smooth, not just challenges to overcome.

Got Questions? We have Answers! Contact us at

Claire WyntersWed, 19 Sep 2012 20:51:00 GMTf1397696-738c-4295-afcd-943feb885714:222699