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International Clinical Trials

Cost Recovery

Given the inevitable changes during trials, sponsors are constantly challenged by unplanned costs when trying to manage budgets. Electronic data capture is one way to reduce these costs and run faster, more efficient trials Ė as long as the right provider is selected

The only certainty in clinical trials is that unexpected changes will occur. In light of this, some in the industry overestimate their electronic data capture (EDC) budget by about 20 per cent to account for the change fees that providers charge over the course of each study. However, for many, this approach is unsustainable. Sponsoring companies should look for EDC vendors that will help them through these changes, rather than ones that penalise them for the unpredictable nature of the trials.

The Right Choice
As trials become more complex and global in nature, a robust, centralised EDC solution has become a necessity for ensuring quality results. A good EDC solution should make the task of entering clinical data as easy as possible by giving sponsors the ability to collect clean data without adding an additional level of complexity. While an EDC solution is a cost to the study, the efficiencies gained by this system over older methods (such as using individual spreadsheets) can more than counterbalance the cost Ė if you choose a suitable product and provider.

However, this is easier said than done. There are a lot of eClinical providers out there, and it can be diffi cult to assess the various options and make the right selection. For small to medium-sized sponsors, some of the bigger names in the space may not give a level of service commensurate with the cost. Meanwhile, some of the smaller, more affordable options may not offer the kind of power necessary for modern clinical trials.

So, identifying an EDC solution that is up to the task and will help improve the sponsorís budget can be a tricky business. The goal is to find an EDC with the power to perform that is also easy to use and intuitive; find a partner that will listen and utilise sponsor input to improve their software and find a provider that will not add on fees for normal changes that occur during the course of any study. This alone could lead to signifi cant cost savings.

Effective Partnerships
Sponsors try to capture data as easily and effi ciently as possible. Using available technologies throughout the process, rather than getting sidetracked by the process itself, helps them get drugs to market faster. An easy-to-use, intuitive EDC solution is essential in achieving this.

EDC providers do not run trials, nor do sponsors build EDC solutions. By developing collaborative partnerships, both can make the most of a mutually beneficial relationship so EDC does what the trials require. EDC providers that are cost-effective from start to finish are also key. Some vendors come into a bid process with a competitive cost proposal, but then additional fees add up against inevitable changes. Preferred EDC providers will understand that changes are opportunities to help the sponsor, not a reason to profit.

Look for EDCs that are powerful yet intuitive from providers that offer a higher-than-normal level of customer service, have an upfront pricing structure that is clear about costs before the trial starts, and do not charge fees for every change over the course of the study. In some cases, such a partnership can trim 10-15 per cent off the EDC portion of the sponsorís annual clinical trial budgets, as well as making savings in resources for EDC development and testing. The time saved inputting data effi ciently can also contribute positively to the sponsorís bottom line.

Long-Term Goals
Overall, it is incredibly important for sponsors to fi nd an EDC provider that will work with them as a business partner and is seeking to build a long-term relationship to meet their needs. A good eClinical solutions provider understands that, while software is at the heart of their business, service will make the difference. Having an integrated relationship should reduce the fi nancial burden of trial changes and ultimately speed up trials, cut costs and clear the path to getting products to patients in need.

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Kevin Nichols is Director, Drug Development Information Systems at Isis Pharmaceuticals. He has worked in data management at Isis for 12 years, where he utilises BioClinicaís Express Electronic Data Capture solution. Kevin has 22 years of experience in data management, database design and development, SAS programming, document management and electronic document publishing in public health and pharmaceuticals/biotech.
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