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Technology-enabled clinical trial management

Supplier: Maximizer Software
07 August, 2012

From its headquarters in Las Vegas, Nevada, Drug Research America LLC, forms a vital link between large, multi-national pharmaceutical companies and medical device manufacturers and the patients of America’s physicians who participate in clinical trials on cutting-edge new drugs and devices.

 

Acting on behalf of its pharmaceutical and device manufacturing clients, the firm is the arm of clinical testing that maintains relationships with physicians, documents their patients and manages the vital processes involved in putting manufacturers and large groups of patients together to conduct clinical testing.

 

To do this, the company's founder Dr. Cherie Thibodeau needed a means of managing ongoing contact with hundreds of participating doctors and their thousands of patients — each with unique characteristics making them suitable for particular clinical trials.

 

Another major consideration for Dr. Thibodeau is the management of private patient information in order to exceed regulatory requirements and help drug companies and device manufacturers with compliance. Having evaluated small business CRM products including ACT! and GoldMine, Dr.Thibodeau manages the business using Maximizer.

 

Playing a vital role

 

In the highly-regulated and competitive pharmaceutical and medical device industries, the testing and certification of new products is a major focus — and a potential hurdle for innovative new products as they move towards widespread use in America's pharmacies and hospitals. Companies hoping to receive Food and Drug Agency certification must first work with physicians to conduct trials of their products in carefully documented clinical trials.

 

Logistically-speaking, trials pose a challenge because only certain patients, with very specific characteristics qualify to participate in each trial. For example, in testing a new cholesterol lowering medication, pharmaceutical companies may require a group of male patients, aged between 40 and 60, with cholesterol of a certain level, living in a particular state, with a previously diagnosed kidney condition and willing to participate in a clinical trial. Assembling such a study group would present a major obstacle were it not for Drug Research America.

 

Using Maximizer, Drug Research America can quickly and accurately search its database of participating doctors and their extensive patient bases — developing a trial group exactly matching the pharmaceutical company or device manufacturer's requirements.

 

Having managed the selection of many new trials over a period of years, Drug Research America has built deep relationships with over 2,500 physicians and their patients.

 

According to the company's founder Dr. Cherie Thibodeau: "Because of the relationships we've built with physicians and our knowledge of their patients documented in Maximizer, we are able to offer our pharmaceutical company and device manufacturer clients an incredibly tailored service. We allow those companies to focus on what they are good at — developing tomorrow's new life-saving products, while we manage relationships with the doctors and patients who will eventually participate in clinical trials of new products."

 

A flexible solution tailored for constant change

 

"If there is one similarity in our work with life sciences companies, it is constant change," Dr Thobodeau said.

 

"No company approaches us with a clinical trial in the same manner as another. They come from different segments of the industry, have different regulatory requirements and require totally different trial groups for their trials.

 

"This is where Maximizer really shines. Using Maximizer's ingenious User-Defined Fields we track not only the preferences of our participating physician network but also the characteristics of their patients — even their participation in past trials. Every single one of these fields is searchable and allows us to quickly prepare reports which show our clients the ideal patient group, the associated physician and all the information they need to conduct a trial of their products."

 

A feature unique to Maximizer, User-Defined Fields allow Maximizer users to create custom system fields without the extensive coding and consulting work usually associated with less flexible CRM products. Users such as Dr. Thibodeau can create a new, searchable field as simply as they would create a field in Outlook. By right-clicking and naming the new filed, users can create a field for capturing information as simple as a contact's age or as complex as detailed notes related to a patient's reaction to a particular drug allergy.

 

Set-it-and-forget-it opportunity management

 

For Drug Research America, an upcoming pharmaceutical drug trial represents a lucrative selling opportunity that must be carefully managed. Often, Dr. Thibodeau will have six month's advanced notice of an upcoming study and can put an action plan in place to recruit a patient group for the study.

 

Using the Maximizer Opportunity Manager, Dr. Thibodeau can track all information pertaining to a particular drug company and the trial it is hoping to conduct. This might include notes related to dozens of drug company employees and their role in the trial, the characteristics of the participating patients required, details of past studies Drug Research America has worked on with the same pharmaceutical company and a list of physicians and patients that might be best suited.

 

"We use the Maximizer Opportunity Manager extensively — both in the steps required to secure contracts to recruit patients for a new study, and also in the actual process of recruiting doctors and their patients," she said.

 

"If the study starts in six months, I can set the start of our opportunity 3 months ahead. The system will then help me time my calls, appointments and other important steps — ensuring that nothing falls through the cracks."

 

In a clever stroke of planning, Drug Research America's healthcare-specific IT consultant Mike Bauerle has installed Maximizer on a server to allow all employees working on a particular project to dial into the database from a remote location using a Virtual Private Network (VPN). Drug Research America credits Bauerle (who has worked with the company since its original decision to purchase Maximizer) with helping the company get the greatest value out of the Maximizer system.

 

"The decision to have Mike load Maximizer onto our server was a great one," Dr. Thibodeau said.

 

"When I am sitting in the headquarters of a major pharmaceutical company pitching our ability to manage their upcoming trial to their engineers and scientists, our Maximizer system does all the selling for me.

 

"I simply run a search on the criteria required for the research, hit enter and Maximizer generates a report including all of the doctors in our network who prescribe that family of medications, the patients we've put into past trials and even notes as detailed as which patients didn't follow through with the study. That's powerful — and something that our clients value."

 

Maintaining patient information for regulatory compliance

 

Healthcare is among the most regulated industries in the United States and the management of patient data must be meticulously documented. For this purpose, Drug Research American takes advantage of several Maximizer features. Contracts, signed forms and other documents are stored in the Maximizer documents field and linked to the patient, their physician, the company putting on the trial research, the company division and even to the contact records of the research organisers at the company conducting the trial.

 

Even Drug Research America's phone system is linked to Maximizer. With TAPI integration to the phone system, Maximizer logs details of calls with doctors, patients and research client officials.

 

According to Dr. Thibodeau: "We document everything in Maximizer, and this is another area where Maximizer's flexibility and reliability are critical. We needed to create system fields in which we could store and organise such a wide-variety of information and documents. User-Defi ned Fields were a very good solution. And, because we are required to store patient data for 15 years and research study-related data for 20 years, we needed to

be very confident in the reliability and ongoing performance of Maximizer."

 

Running a successful business

 

In addition to the company's sophisticated use of CRM to manage the sourcing of clinical trial patient groups, Drug Research America also relies on Maximizer as the dashboard of its business for more routine tasks.

 

"I use the Maximizer Calendar extensively to organise my practice," Dr. Thibodeau said.

 

"I also use the Address Book to keep in touch with the physicians in our clinical trial network. The system is also handy for promoting collaboration amongst these physicians — many now also use Maximizer so that they can instantly import their patient's information into our database and assist them in participating in clinical trials that might benefit them.

 

"I can say with certainty that we couldn't run our business without Maximizer. We rely on its flexibility and reliability on a day-to-day basis. For us, adapting to change is par for the course. If your software can't change with you like Maximizer can, you can't exist in our industry."