If you need to find a Starbucks in SFO airport, there’s an app for that. If you need to simplify study startup, you’re SOL.

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

Travel Apps… how did we ever get around without them?

The first step to your long awaited tropical island vacation is to go to the airport. There are a number of factors that can delay your trip, first is the traffic to the airport, then there are lines at check-in, the long security line, and wait for it… delayed flights. There are a number of tools out now to help travelers with all the factors just mentioned, you can go online on your computer or use a few of your smartphone “Travel Apps (Applications)” to help you.

You can check traffic to see how long it will take you to get to the airport, check the airport website to see if they show information on the security line, and check the airline website to for your flight status. Delays can be caused by a number of things, like weather and or security alert levels. We use three different “Travel Apps” to help us along the way.

The Angst of Clinical Study Startup

Just like air travel, clinical study startup is the first step in starting a clinical trial. Everyone loves to get a new study going and it fans the flame of being able to get critical medicine to the people that need it the most. Unfortunately more often than not, this part of the trial is what can be the most problematic to the sponsor and is followed by slow patient recruitment as the number one problem with a drug study.

The average delay due to slow study startup is in the area of 4.6 months per trial and at a large pharma/biotech company can not only add years over the course of time but also negatively hit the bottom line as well. Daily losses once a drug is approved due to these roadblocks can run from $500K to a staggering $8MM in lost revenue. Got your attention, huh?

One of the reasons why the study startup process is slow is because it is a labor-intensive and paper-heavy process and is still very manual in nature. Like trying to move and then steer a rhino with a stick. Sure you can get it going but it is not so easy to control it and keep it moving. In this day and age of readily available technology the simple Excel spreadsheet is still the most widely used system in play. Sure this is great for the study coordinator but what if Mandy or Lenny are out sick that day? Well, you are “S.O.L.” to paraphrase Clint Eastwood.

This poses one of the major issues in delays with study startup, no central repository for study info, no coordination of notifying and/or initiating sites, updating of patients recruited not being rapidly relayed to team members, all lead to start up being delayed or slowed to a crawl. On average most spend up to 4 hours per week just looking for documents. Close to 25% still rely on sending docs overnight for review and almost 30% are still faxing. Having to resend/refax due to loss of docs is ridiculous. Still using paper keeps costs rising as well and again, not to beat a dead equine, delays study startup and puts more dollars in the red side of the balance sheet. Add up having to update and re-issue 1572’s at $159 a pop and you are in a spiral of costs.

Some useful tools that help

Just like “Travel Apps” there are there are a number of technologies out there that can help study startup managers to reduce the churn in delays. We use them all the time, like e-mail, folders on our computers, scanners, to do list applications, all there to help managers stay on top of things. But keeping track of everything using so many different tools can add to the burden, as if study startup is not enough. Look at some of the apps we use at goBalto to stay on top of it all.

1. 1. The Non-App: We like to call this category the “Analog Residue,” which include pens, papers, and the trusty courier; it works, its fine, the bad part about this is that its slow, and expensive, not to mention time spend in line to send the parcel out. We try to avoid this if we can.
2. 2. Ubiquitous Excel: it’s a great application we have been using since the beginning of time. We can make charts, make storable tables, but it does have its limitations. Data collection and reporting are manual processes, collaboration is not easy and real time tracking is not so evident.
3. 3. Basecamp: goBalto has used basecamp extensively, a project collaboration tool that is simple and easy to use in a fixed format, there is not much customization here. We use it to share ideas, and keep everyone linked together.
4. 4. Google Docs: Google Docs is a web based document application. We use it to post documents that team members’ work on together. We use it on the go or when working remote, because all you need is Internet and a web browser to access it.

The applications listed above are helpful to some extent. They are far from perfect and we often find ourselves thinking: it would be nice to have a ‘purpose built’ solution that meets our needs.

Sharepoint may be layered in with other tools (like Excel spreadsheets) to try to create some level of collaboration, but its use is limited and not so straightforward.

These are more akin to “patchwork” solutions…as opposed to something that is ‘purpose-built’. Think: Travelocity or Amazon.com – both purpose-built, with simplicity that attracts all users. But no one would ever consider combining the two or using Travelocity to find the best deals on the latest greatest best seller.

Closing Thoughts

Delays are sometimes inevitable; out of our control. But, with purpose-built tools that harness the power of “Cloud Computing”; huge leaps in efficiencies in communication, task and document management as well as a transparency not before available to clinical trial management can help generate time and cost savings which will help bring more new therapies to market quicker and cheaper.

Great applications for the travel industry help travelers world-wide to save time and money when traveling. Mostly though, they are just making our lives a bit simpler when we travel. A purpose-built clinical management program should also make the user’s life easier. It should help reduce the overall cost and time to manage the process. Ultimately, a great solution will help the users gather critical information helpful in future planning of other clinical trials. It does not stop with a slick system to send a CDA.

We are on the constant lookout for how other industry professionals are addressing the istudy startupes of study startup management. Please let us know what is working (or isn’t working) for you.

To learn more about how cloud computing can help study startup, contact Leif Erickson at: lerickson@gobalto.com.

About the Author
Leif Erickson is a Director of Business Development at goBalto. He has over 19 years of experience in the pharma and biotech industries, including 5 years of research at 2 La Jolla based biotech companies and helped start the Diversa Corporation.