SpotlightBrochure-March17-DFSPharma

SPOTLIGHT ON BUSINESS MAGAZINE

MARCH 2017

DFS PHARMA

By David MacDonald S potlight on Business Magazine: And you’re more in-tune with these technology-driven changes than most CROs? I’ll be honest, Rod, I’m a layman here. Can you please explain what services a pharmaceutical CRO typically provides? RM: DFS Pharma offers a host of pharmaceutical research services, but are by no means a traditional contract research organization. We have key strategic partnerships with technology services and like- minded clinical and statis- tics partners to provide a customized study team that will exceed the experience provided by a traditional CRO, while still maintaining costs due to lower overhead and preferred partnerships. What we specialize in is full data management services.

DFS Pharma is a Contract Research Organization (CRO) specializing in pharmaceutical data management and statistical support. They partner with like-minded domestic and international CROs to offer clients in the worlds of biopharmaceuticals, biotechnologies, and veterinary medicine a fluid sponsor-consultant experience. “The industry has changed quite a bit over the last 20 or so years,” Rod McGlashing, Senior Director of Operations for DFS Pharma, told me as he quickly returned a text to a client before I asked my first question. He apologized for the necessary delay as the distinct buzz of a phone turning to vibrate could be heard over my speaker. “It has moved from a strictly paper- based data collection model that required a great deal of transcriptions and, as a result, a great deal of transcription errors, to an Electronic Data Capture or EDC model, where clinical sites enter the clinical data directly into the data collection instrument or study database,” he continued. “The industry is now moving toward technologies that work to sync the bedside source data with the clinical database via mHealth or eSource, thereby eliminating the possibility of additional transcription error. That being said, the industry is slow to adapt. And for good reason, as the required regulations addressing the safety of patients is the utmost priority. These technological and related procedural changes are advancing hand-in-hand with industry standardization as it relates to the data and metadata, and international harmonization amongst the various regulatory bodies and industry leaders.” I quickly changed my approach to match Rod’s momentum which, I learned, is also the approach DFS Pharma takes every day with every client.

“The industry is now moving toward technologies that work to sync the bedside source data with the clinical database.”

Generally speaking, who are your clients? RM: Anyone who needs assistance in conducting their clinical trials, either because they don’t have the resourc- es, or don’t have the expertise in-house to build clinical databases or perform data management tasks. “We have key strategic partnerships with technology services and like-minded clinical and statistics partners to provide a customized study team that will exceed the experience provided by a traditional CRO.” And what are they looking for specifically that DFS Pharma does better than your competition? RM: DFSPharma’s goal is toprovide an experience that allows flexibility to meet the needs of the client and various regu- latory bodies. We don’t think the ‘one size fits all’ approach that most CROs take is good for the client or the industry. We don’t want to force the square peg into a round hole, we want to adapt to the individual situation of each client.

We also want the client to know that they truly mean something to us. We consider our relationship with our clients to be a real partnership, not just a paycheck. We take pride in providing our clients with a focus on their clinical study needs, and again, we think our flexibility goes hand- in-hand with this philosophy. If they succeed, we succeed. When did you begin your walk on the road to success? RM: DFS Pharma was started on July 3rd, 2013 by myself and co-founder Tom Andor. Tom came up with the idea of creating a data management consultancy, and as the company has grown and our vision has come into focus, that original idea has morphed into the flexible CRO model you see today, one that specializes in data man- agement like no one else. Both Tom and I started in the industry in the mid-1990 and met while working at another CRO. We talked about starting up our own company on many occasions. What are your backgrounds, Tom’s and yours? RM: Tom attended the School of Pharmacy at the State University of New York at Buffalo and graduated with a degree in Biochemical Pharmacology specializing in Pharmaceutical Sciences. I attended St. Mary’s Universi-

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ty in Halifax, Nova Scotia and graduated with degrees in Business and Psychology. It’s our diversity of mind that makes us stronger. DFS Pharma personnel have varied backgrounds. The things we look for in our personnel are an ability to think critically. We expect our people to be able to provide guidance, not just follow cookie cutter templates. We want them to be dynamic. At the same time, we also look for people who are extremely detail-oriented. We are in a highly regulated industry, so the ability to adhere to rules and regulations is also some- thing we look for. How is it that such a young CRO has so quickly rein- vented the sponsor-consultant dynamic? RM: Since DFS Pharma is a relatively new player in the CRO world, we haven’t had the growing pains that some of the more established CROs have; however, we have been able to leverage our previous experiences to have the foresight to see where the industry is headed. We’re basically a fresh company with a wealth of industry expe- rience and this has allowed us to align ourselves with the right technologies and partners without ever sacrificing quality or vision. DFS Pharma is the CRO of the future, now. That’s because we have reinvented the sponsor-con- sultant dynamic. Traditional CROs are tied up with trying to be everything to everyone. We know we can’t be that, so we look to our equally forward-thinking partners, lever-

aging their individual experience and industry focus to cover what we, ourselves, don’t. Again, a traditional CRO would try to force what they have at the client and say, “this is what we’ll do.” We look at their needs and create an adaptive, flexible package. You can kind of think of DFS Pharma as the hub of the wheel. “I guess you can say that in this line of work, those who do it right, inevitably teach.” I think everyone reading this will get a sense of the progressive posture you take as a company, but can you please tell the readers about your employee culture specifically? RM: Absolutely. DFS Pharma values its employees. We know they are the greatest asset we have and we try to be flexible – there’s that word again – with their needs as well. We expect people to do their job and do it well, and take pride in their work. This is a stressful industry, so we don’t want to add any additional stressors. In fact, we want to remove them as best we can. DFS Pharma believes in team building and has activities outside of the office to develop successful relationships among the employees. Our social activities often include our families, so you

ePRO allows the collection of daily diaries and other patient reported information to be collected directly from the patient; this often will fall under mHealth.Medrio, Merge, and Oracle all provide EDC platforms, though all four, including Trialogics, offer other modules that relate to the conduct of clinical trials. By having a range of partners in this space, we are able to work with clients based on their study and budget- ary needs. The phase of a trial, the number of patients, amount of data points, module needs and integration, and other aspects go into the selection process of which technology would be the best fit. What has been the industry response to your business model? RM: Well, it’s an industry like no other. I guess you can say that in this line of work, those who do it right, inevitably teach. DFS Pharma attends, and presents at many confer- ences and industry events every year. Recently, we took part in a panel discussion, sponsored by Oracle Health Sciences and the North Carolina Biotechnology Center, on RBM [Risk Based Monitoring] in the Cloud. Our very own Tania Sholar was a key panelist in the discussion, who focused on RBM from a data management perspective.

Additionally, DFS Pharma is presenting firsthand insights

can imagine we’re a pretty close-knit group here. At DFS Pharma, meaningful employee connections are key to our robust working relationships. “We consider our relationship with our clients to be a real partnership, not just a paycheck.” Earlier you spoke about leveraging the individual experience of your partners in order to provide an adaptive package to your clients. Who are some of these partners and how do they help the DFS Pharma team achieve its goal? RM: I’m glad you asked. LLX is our key biostatistics and SAS [Statistical Analysis System] programming partner. Its team has proven expertise in supporting global clinical trials for companies of various sizes in the United States and in various therapeutic categories such as cardiology, oncology, rare disease, medical devices, pain, infectious diseases, neurology, allergy and immunology, endocri- nology and metabolism, as well as gastroenterology and pediatrics. Medrio, Merge (soon to be called IBM Clinical Development), Oracle, and Trialogics are all technology partners of DFS Pharma as well. Trialogics is primarily an ePRO or Electronic Patient Reported Outcomes company.

into scheduling with ePRO. We’ll be discussing rule triggers, login and testingwithGmail, and scheduling and description tips for daily diaries at the mSquared (Medrio) users’ confer- ence, in late March 2017. Also, I’ll be moderating a panel on Clinical Study Build Validation at the same conference. Tania will be attending the Outsourcing in Clinical Trials South East – or OCT – conference on March 21st and 22nd in Cary, North Carolina. The conference is a local- ly-focused event that picks up on key challenges faced by small to mid-sized biotech and pharma companies in the Southeast and looks to facilitate learning and prob- lem-solving through case studies and discussion amongst peers. If you are attending either the Medrio mSquared users’ conference or the Outsourcing in Clinical Trials South East conference, please make sure to make sure to

flexibility and client focus thereby delivering high quality data for regulatory submission and a healthier, happier populace.

Rod spoke with Spotlight on Business Magazine in late February from DFS Pharma headquarters in Wilming- ton, North Carolina. DFS Pharma can be contacted via Linkedin, on Twitter as @DFSPharm, or through Facebook and Google Plus.

connect with your DFS Pharma representative. What does 2017 look like for DFS Pharma?

RM: 2017 looks great for DFS Pharma. 2016 was our best revenue generating year to date and saw the company add to its headcount. Looking at the partnerships that we have, both with our vendors and our existing clients, we expect to continue our growth in 2017.

Long term, we hope to continue to expand the number of partners we have to continue to provide greater and greater

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as spotlighted in the MARCH 2017 issue of SPOTLIGHT ON BUSINESS MAGAZINE

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