Data Collection with Mobile Devices Is So Cheap

There is no bigger headache for drug companies than clinical trials. For a patient waiting for the approval of a medication in a clinical trial, there is no wait longer. What many people don’t realize is that the bulk of the time consumed in the multiyear studies is actually absorbed in inputting, compiling, and analyzing the data. And it’s not just time. The labor costs associated with these data collection procedures are daunting.

I’m specifically using pharmaceutical trials as an example because they are some of the most costly and exacting in terms of data management and collection. If there is a solution that benefits this industry, it can be adopted to nearly any other vertical market with identical benefits.

The leader is in this area is Numoda, which is setting the standard for wireless data capture and can miraculously get a typical project into a wireless environment in as little as three weeks (case histories of a few days exist).

While Numoda offers services for the financial community, government, insurance, and especially industries focused on sales or other types of businesses that rely on field reps, their work in pharmaceuticals is particularly notable, especially for their extraordinary returns on investment, which are guaranteed (for any industry segment) at a minimum of 200 percent and have been documented as high as 1,000 percent.

Pre-wireless, new forms had to be printed and distributed to account for the addition or deletion of patient information. With a wireless solution in place, amendments are no longer encumbering in the least, since all that is required is an interface update, which can be handled when the data from the device is uploaded. Gone is the expense of designing new forms, printing updated ones, or storing new and old versions.

Furthermore, these fully electronic studies greatly enhance the security of CRFs because no one has physical access to the paperwork. Since the data is completely digital, the CRFs do not have to be physically stored, nor do they ever have to be accounted for or eventually destroyed at the end of the trial. The processes described, which include protocol preparation and case report form preparation, database programming and data entry cleanup, and costs related to incomplete paperwork, typically total about $680,000 for a manually conducted trial. However, this figure is reduced to a mere $29,500, about 95 percent less, with the introduction of Numoda’s mobile technology.

However, the biggest expense is incurred in relation to managing the up to 30 sites typical of a larger trial. A budget of about $3 million is average for site monitoring and management as well as general project management.

The reason these expenses are so high is that clinical trials have complex requirements. Patients have to be seen at different times, in differ-ent stages of the trial. For example, at a particular site there are 4 investigators, each screening 40 patients; each investigator conducting the trial on the 38 of those who make it through screening, all coming in at different dates, days, weeks, months, and even years apart. Each patient has to come in for four or more visits, all within a precise and documented time frame. Now keep in mind that this could be happening in as many as 30 sites in 30 different states.

Before the integration of a wireless solution, it was impossible for a site monitor, the person who oversees the trial, to be certain all the CRFs were being completed by the appropriate person at the appropriate time in accordance with protocols, their amendments, and the rigorous standards for controls, blinding, randomization, and size. It is the responsibility of the site monitors to ensure and eventually prove the integrity of the data; therefore, they tend to be a fastidious group, traveling constantly from site to site to ensure accuracy during the manual data collection process.

The frequent flier accounts of site monitors are not what they used to be for those who use Numoda’s solution. Now much of the monitoring is done remotely, by viewing the results electronically. Because the inefficiencies have been eliminated (most notably the accuracy of the inputted data), the monitor has complete confidence in the interim results viewed without having to physically check the patient case report forms. Being able to catch potential errors in near real time avoids fines for FDA violations due to nonadherence to FDA guidelines, something often discovered months or years into a trial, when it’s close to impossible to fix.

The biggest benefit outside of the monetary advantage is that Numoda’s real-time reporting assures that the clinical trial is maintaining its goals and quality of data today, not four months later when the paper trail catches up and it is determined that an amendment is necessary. Using the nonwireless, nonelectronic method, in just four months several dozens of patients could be enrolled, several hundreds of pages of data collected, and several millions of dollars wasted.

Now, instead of millions being frittered away, millions are saved. The bottom line is that even with Numoda’s service fee of $366,000 (based on the parameters above), the net cost reduction totals more than $2.6 million. This means that a budget of $4.75 million for a manual trial is reduced to about $2.15 million, a 63 percent savings, and a return on investment of 712 percent.