CBI Scene Blog

Streamlining Operational & Functional Processes in Global Clinical Trials

Posted by Michi Beck on Jan 16, 2014 3:01:00 PM

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Many of the past demands of clinical trial development are changing, and companies must also change by streamlining their operational and functional processes as well as more effectively leverage technological solutions. Doing so will provide higher quality clinical trials that allow for more accurate and timely results, especially where global trials are concerned. Because so much effort is needed to coordinate clinical trials on a global scale, streamlining is becoming essential to the process.

The Challenges of Streamlining Global Trials

Currently, global trials have a lot of duplication. This is seen in everything from the feasibility tasks to review and monitoring options, and it's one of the biggest problems these kinds of trials face. That duplication becomes a serious challenge in two different ways:

  • The duplication negatively affects the cost
  • The duplication negatively affects the timeline

Naturally, both of those are serious issues that can add to the total financial and human cost of the project. Since clinical trials are a huge step toward getting a medication or medical device approved, performing them efficiently is a significant part of the process from initial idea to seeing the device or medication on the market. If the clinical trials are unsuccessful, the product used in the trial will likely not proceed any further.

Outsourcing Models and Global Trial Complexity

Current outsourcing models are focused too intensely on individual steps in the global trial process, which is complex in nature. While proper focus on each step while it is being completed is important, there is little continuity between steps. A lack of tie-in and a lack of streamlining both contribute to excessive and unnecessary costs that could be avoided. Additionally, the trials take up much more time than they would otherwise need to, simply because there is overlap and confusion in the process.

There is great value to outsourcing in global clinical trials, but only if it's done correctly and with a clear understanding of what has to be completed. Language and cultural barriers can affect how outsourced teams work with the originators of the clinical trial, and there are also time and distance issues that can affect the way the trials are conducted and how the results are handled. That can result in information that may not be as accurate as desired.

The Need for Technological Solutions

Because of the discrepancies that take place when there are many outsourced activities in a global clinical trial, there is a clear need for technological solutions that will streamline the process and lower the chance of mistakes. This is very important to consider, because mistakes in clinical trials can affect a large number of people who use or purchase a medication or medical device once it has been approved for the marketplace. If the trials do not provide accurate information, people may be at risk from faulty or dangerous medications or products. It is also possible that people who need a device or medication will not be able to receive it, due to perceived but inaccurate risk.

A Turnkey Approach to Global Trials

Global clinical trials need a turnkey approach going forward. This will allow them to move smoothly and seamlessly through the process without long delays and unnecessary expenditures of financial and human resources. While these approaches can take time to create, once they are completed they can be used again and again for various trials. That makes them extremely valuable to the medical community and can prevent errors and omissions that can otherwise be damaging to the trial and can stop a much needed device or medication from being approved.

Among the strategies for a turnkey approach are those that can simplify, standardize, and improve the quality of global trials. Too much is left to confusion and misunderstanding when there are vague directions or not enough quality control across the teams who are conducting the trials. That can easily happen with trials on a global scale because of the differences in the way these trials are handled in each country. Having one standard way to address all issues would be highly beneficial.

Want to learn more about how you and your team can streamline the operational and functional processes for your global clinical study? Join us at Clintech 2014, March 11-13th in Cambridge, MA where Daniel O'Connor, President and Chief Business Officer at InnovoCommerce will host a session titled "A Systematic Approach - Measure the Effectiveness of Collaboration Involving Site Activation, Study Start-Up and Study Conduct in Global Trials." Hope to see you there!

Clintech 2014 conference

(Image courtesy of Chris Potter via Flickr)

Topics: Clinical