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Tutorials : Jan 15, 2010 (Vol. 30, No. 2)

Virtual Management of Clinical Operations

Novel Web-Based Technologies Can Automate and Facilitate Trial Workflow
  • JeanMarie Markham
  • ,
  • Nikki Bonnell

In 2005, there were 8,386 clinical trials costing nearly $24 billion in the U.S. alone. With clinical development being the longest and costliest phase of drug development, implementing best practices and streamlining processes in clinical trial management is a prime way to improve efficiencies, cut time, and reduce the cost of investigational product development. However, few succeed in maintaining best practices throughout a clinical trial, and potential savings are rarely realized. Much of the cause is the use of technology based on old business models.

Using technology for technology’s sake under old business models will continue to result in failure to succeed. Traditional processes and function-specific software used by pharmaceutical, biotechnology, and clinical research companies are housed internally but are rarely compatible with each other. Because of parochial silos, turf wars often negate any of the positive improvement that technology and access to all available data can bring.

As a result, certain technology platforms have been underutilized, leaving sponsors wondering why they invested in nonpaper-based processes with marginal return on investment. The inefficient and unsatisfactory paper-based processes and disparate software tools based on old business models must give way to new era tools that automate and facilitate the clinical trial workflow process, making them more efficient and visible.

Clinlogix, a global full-service eClinical Research Organization (eCRO), sees the need for the clinical study process to change to help companies be more productive and competitive in this new era of biopharmaceutical and medical device development. To that end, Clinlogix has created a virtual development pathway that incorporates into its services certain new web-based technologies.

These technologies are based on new business models, further automate the clinical trial management process, and enable efficient project management. Designed to facilitate the clinical trial process, these web-based tools provide access to information, and integrate, connect, report, and deliver valuable project data and milestones and enable better cost management. 

Optimization of eTools

Clinlogix services utilize a portal to connect stakeholders of the study team, deliver information and data as valuable project milestones, and allow real-time collaboration and decision making for events (Figure). Developed by unithink, a Belgium-based eClinical company developing data-collection and management technology, the thinkClinical™ software uses a single intranet log-in.

The study team has access to and can now share real-time data such as safety, electronic data capture, clinical trial management system, clinical data, and patient reported outcomes. This simplified collection and consolidation of data and information in a single accessible database takes clinical trial management to a new level of efficiency in process management. The ability to view all available safety information facilitates its monitoring and review, and optimizes its interpretation for the first time.

The utility of the thinkClinical software is illustrated in a clinical trial project managed by Clinlogix that required 120 patients to be enrolled by a certain date. The software provided the optimal number of investigator sites, the number of patients per site, and estimated the rate of patient enrollment in order to meet that goal.

Most importantly, the software allowed a view into what-if scenarios. By entering a firm end date, the tool estimated the number of sites needed to meet the enrollment goal. By entering a flexible end date, the tool estimated the new end-of-study date and calculated the impact on the original study budget in both scenarios. As enrollment proceeded, stakeholders could see if the project was ahead or behind schedule and were able to make informed decisions with sound information to present to management. Thus, Clinlogix was able to process and methodically provide status information in relation to milestones and forecast impact.

The web-based thinkClinical software provides a new level of visibility and transparency of available clinical trial information and progress—much more than just patient enrollment. Information such as the clinical data, regulatory status, patient enrollment, safety events and reports, and even the budget and spending can be viewed and interpreted, resulting in informed decision making. The value is the ability to monitor projects in real time and to understand the financial and scheduling impact of changes and course redirections for smarter go/no go decision making while eliminating redundancies that are currently present.

New Paradigm Emerges

The old and inefficient model of managing multiple databases and vendors by manually compiling data from disparate systems with multiple places to go for review of information is an inefficient and costly way to do business in today’s world. A new paradigm is emerging that leverages technology, best practices, and well-trained project managers to execute and optimize the technology, thus providing great benefit and cost savings to companies with assets that need to be developed.

Clinlogix has created a virtual development pathway that allows companies with assets that require development, to access a single platform with the requisite management talent of services such as the monitoring, data, safety, and regulatory as needed to successfully move their investigational product forward.