To get a new drug to the market is a long, hard road. Research and development cycles take years to complete and U.S. Government regulations require stringent testing methods to ensure the safety of the public. Once all these obstacles are passed and the drug becomes available, the really hard part begins; getting the public to accept it and buy it.
Years of experience has proven, the most effective method for promoting new drugs is by giving free sample medications to physicians who then pass them onto their patients. Free samples from the pharmaceutical company sales representatives are the core of the pharmaceutical industry's marketing strategy. It demonstrates to the doctor and the patient the successes of the years of research and testing and allows the patient to begin treatment immediately before they leave the doctor's office.
But just because the medication has made it to market does not mean all the hurdles have been taken away. A law called the Prescription Drug Marketing Act (PDMA) requires every one of the more than 80,000 pharmaceutical representatives working in the United States to fill out a form each and every time they distribute free samples to a physician. And because each of these samples is officially a product available only by prescription, each form must be filled out completely and correctly or severe penalties and fines can be imposed on the pharmaceutical company. With dozen of sales calls to physicians in a week, the number of samples given out by each sales representative can easily reach well into the hundreds. Multiply that by the number of pharmaceutical representatives working in the country and you can begin to imagine the challenge.
Amid all the chaos of this process, Bob Neubert saw an opportunity. "I worked at one of the largest pharmaceutical manufacturers in the U.S. for several years and I saw firsthand all the effort that went into bringing a new drug product to market." Neubert also saw all the paper being generated as a result of the Government PDMA regulations. In the paper, Neubert saw his opportunity. Here was the challenge: to come up with a solution to automate the processing of all those paper forms, and the ever-important data on them, while making sure all the PDMA standards were met, and to do all of this while remaining cost-effective for the drug companies. Neubert chose to accept the challenge. "I knew it could be done, but it had to be done right."
Neubert founded a company to do it, Dakota Services, Inc. His goal was to provide comprehensive sample accountability services to enable his customers to comply with every one of the complex PDMA regulations. He knew he had found a niche in the market; his expertise would be in great demand, but now he needed the tools to carry them out.
The most important piece of the puzzle was the automated data capture solution. He began looking at all the players in the automated document and data capture industry. "We needed a fast system and it had to be able to grow with us as our company and our customer base grew. But most important, accuracy was essential. 99.9% wasn't good enough, we needed 100% to make sure our services would comply with the law," says Neubert, president of Dakota Services. "OCR for Forms™ from Microsystems Technology (www.mti-info.com) was exactly the software we were looking for." To round out their solution Dakota purchased multiple Kodak 3500 scanners and created their own proprietary database to store and analyze the captured data and images. "We created a database that we can customize for each individual customer's needs for both storage and immediate retrieval onscreen."
Neubert continues, "Beyond just compliance with the law, the challenge we faced was to make sure our customers would receive a return on their investment to justify outsourcing to us." To do that, he knew the place he needed to look for his labor was offshore. "OCR for Forms gave us the ability to utilize overseas verification operators with its Remote Verification feature." Remote Verification allows users to scan documents into the system at a main location, and allow users at another location to dial into the system to perform data verification. This remote verification feature works between floors in a building, across the street and, as Dakota Services needed, around the world.
After looking at hundreds of sites and extensive testing worldwide, Dakota chose to locate its facilities in India. Dakota Services operates two offices in India, one in Bombay and one in the capital city of New Delhi. "India had the workforce we were looking for, highly educated and dedicated workers we could train to do the job right." And because of time zones, speed became a welcomed by-product. "We have our people here in Pennsylvania scan in the documents during our work day and overnight we have two shifts working in India to verify all the batches. All the work is then returned to us electronically before we come in the next morning. "All the paper, the software and the controls remain here in our main office. It never has to leave the building." By locating the verification staff overseas, Dakota Services is able to function as a complete 24-hour operation. Utilizing remote verification, Dakota Services is able to take advantage of a reduction in the total cost of data capture of an average of 30%-50%.
As they continue forward using this unique solution, Dakota Services has even found a way to increase their already high productivity levels. Making use of the data from OCR for Forms' built in Statistics feature, Dakota Services has a specialized program to measure each operator's productivity. They can then assign each operator to their most productive tasks. Neubert explains, "Using the statistics, we can route a particular type of form to the best verification operator for that type of form. We can also focus our training on the specific areas of an employee's needs." This personal approach for each worker keeps the level of morale high and turnover low. Because of this, Dakota Services has already seen a 30% increase in worker's speed and productivity.
Dakota's customer-base represents more than one quarter of the drug sales representatives in the U.S. On average, Dakota processes more than 300,000 documents weekly for PDMA compliance. By utilizing remote verification and automation, Dakota's customers receive up to 75% in cost savings as opposed to processing the paperwork themselves. "One of our clients has reported a $1.8 million savings and that's a good example of the type of results to be had," says Neubert.
As a customer of OCR for Forms, Dakota Services was so impressed with the software's abilities; they have chosen to become a reseller for Microsystems Technology. "It's a logical step for us. Some companies embrace the idea of outsourcing and letting us do the work for them, but others, for one reason or another, can't give up the need to hold on to their paper forms. As a reseller, we can go in and create a solution for them internally that will still increase their speed, accuracy and productivity. It's a no-brainer for us and the customer can still benefit from our years of experience."
Dakota is now a finely tuned turnkey solution for the entire pharmaceutical industry. "Because we choose to focus on data capture requiring high accuracy rates, all of our efforts go into providing exacting quality and data analysis. We attend all industry conferences and monitor the FDA for any changes. We even go so far as to employ attorneys to monitor any changes in the laws so we can immediately incorporate those changes into our solution." Dakota is even able to stop sales representative's mistakes before they become a problem. "When we scan the document, we have an internal check which identifies errors automatically. If one is detected, an automated e-mail and a PDF of the document is sent to the appropriate sales representative for correction."
As for the future, Neubert sees nothing but potential. "We know we already have the best solution for the pharmaceutical industry. We're going to take the same high-quality approach and go after other industries that sorely need automation." Dakota Services is focusing its new efforts on accounts payable (invoices), hospital administration (EOBs and HCFAs), insurance applications, and higher education (admissions and student loans). "They already know they're throwing money away on manual processing, they just don't realize there's a better method available right now."
Submitted by Microsystems Technology