April 8, 2013 Issue
The Most Powerful Name In Corporate News and Information
As a Global Provider of eClinical Solutions and Niche Clinical Research Services to the Life Sciences Industry, ePharmaSolutions is enabling Pharmaceutical Companies and CROs to Identify and Recruit Patients for Clinical Trials while Reducing the Paper and Manual Process
ePharmaSolutions is a global provider of eClinical solutions and niche clinical research services to the life sciences industry. Its award winning eClinical solutions support over 330,000 users in over 130 countries for the world’s largest biopharmaceutical companies and CROs.
Clinical Services Provider
Building E, Suite 402
Conshohocken, PA 19428
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – April 8, 2013
CEOCFO: Mr. Converse, would you tell us the vision when you started ePharmaSolutions, and where are you today?
Mr. Converse: The vision when we started the company was to develop a common technology platform for pharmaceutical companies to identify and recruit clinical trial sites and for those clinical trial sites to identify and recruit patients for their clinical trials and to use that technology to provide single-sign-on access to everything that they need to manage that entire process for global clinical studies.
CEOCFO: Is that different than what has typically been available?
Mr. Converse: It is different because most of the companies that we see in the market are more “point” solutions, so that they focus on one specific part of the process and they do not provide a more holistic solution. What we aim to do is to provide technology that brings together some of those point solutions, and close the gap in areas where point solutions do not exist, and provide that single sign on platform for people to use. An example of that would be electronic data capture technology. That is an area that has true market leaders already in that space. We would not develop something in those areas; we would actually partner with these vendors and integrate with our solution.
CEOCFO: How has it worked out so far?
Mr. Converse: It has worked out very well. We re-architected our software about three years ago, to build it on the most recent Microsoft based technology. As part of that, we were able to integrate many new features into the solution; for a more simplified workflow for the study teams as well as the clinical trial sites. As a result of that we now have a highly scalable platform that is quickly gaining market share. We doubled our sales last year and we are on the same velocity this year for 2013.
CEOCFO: Have people been looking for a better solution?
Mr. Converse: I think they are looking for better solutions. One of the things I am disappointed with in this industry in general is that there are still a lot of companies implementing point solutions. Maybe it is a budgeting issue. I am not exactly sure why the industry continues to do that, but after twelve years in the business I am finally starting to see pharmaceutical companies and CRO’s, Contract Research Organizations, start taking a step back and look at these solutions more holistically. When you try to integrate some of these point solutions that do not talk to each other, you actually see an increase in business process and cycle time. It is actually taking more time to manage the process using several point solutions than if you had implemented something that was more holistic that handles the entire clinical development life cycle. Those are some of the challenges that we have seen. However, I think the tide is finally starting to turn as more pharmaceutical companies need to improve business process. The clinical research organizations that they work with are getting into more fixed based, fixed price contracts, and they need these solutions to improve the business process and reduce many of the manual paper based processes and double or triple data entry that we see when these point solutions are rolled out independently.
CEOCFO: When you look at organizations to partner with you or to be part of your comprehensive solution, what do you look for? How do you know all the various companies that provide the quality that you want and be a good part of your team?
Mr. Converse: That is a good question, too. We do not have a lot of time to focus on partnerships with companies that may or may not be around in a year or two, or may not have the scalability that we would need at the level we operate. For example, we work with three hundred and thirty thousand users in one hundred and thirty countries for some of the biggest pharmaceutical companies in the world. There are two or three thousand studies that are currently active on our system. To work with a smaller, new company, for example, that might want to partner with us; while it might sound like it is a nice little feature or a nice new technology that is out there, if we spend a lot of time doing the integration and the validation of that system and learn later that the quality or the technology does not scale, that is an enormous waste of time for both parties. What we look for when we are focus on a partnership with either a technology partner or a service provider is people that have been around for five to ten years, that have a reputation for being best in class, or at least the top three in their market. We also focus on making sure that we get good client references. Many of the times we enter into partnerships that have been facilitated by a client.
CEOCFO: How do you reach perspective customers? What is the “aha moment” when they understand that your approach makes sense?
Mr. Converse: Of course, we have a sales team that reaches out to our clients. We actually have two buyers in our operating model. Because we are a cloud-based solution we are able to provide our solutions at the clinical trial level, as well as at the enterprise level. When we are selling it at the enterprise level we are actually selling in to the informatics folks. Those are the people who usually tend to have gone through a process of getting requirements, understanding what the business problems are and what they need to solve. Therefore, they usually have a better understanding of what they are looking for and what they need to do to integrate something that is going to solve a corporate problem for their company. The buyers at the clinical trial level are really focused on streamlining their particular study. They are looking for solutions that will help the accelerate the clinical development for that study, or help them select the right investigators, or help them accelerate the recruitment of patients. Therefore, the “aha moment” for these buyers typically comes at the project level when they have gone through the process of using our technology and see the time and cost saving. The solution provides one user name and one password for each user, so that they do not have to remember five or six different logins to different systems for each study. They start seeing how fast they are able to activate their clinical trial sites, and how they can do that with one technology and one service provider, verses five or six. We think the “aha moment” with enterprise implementations of our software is the significant cost savings that they can realized along with the ease of implementation. That is because implementations with a cloud-based solution are much faster and much more efficient than they are when you are doing an install of enterprise software on an application. The integrations are easier, so when clients integrate a cloud based software they are seeing significant cost savings, ease of implementation, and secure hosting as the major benefits.
CEOCFO: You recently announced some upgrades to your technology. What have you changed and what have you made better?
Mr. Converse: You have done your homework! Good! We have launched two things. One, in 2011, was the integration of our clinical trial portal with our electronic trial master file. Again, this goes back to the benefit of integrating these solutions and making sure that you have one system that simplifies all of the business processes and reduces the manual steps that would be required from separate systems. That is a pretty important innovation in that it provides “cradle to grave” electronic document management from the time a protocol gets developed to the time clinical trial sites log in and complete all of the regulatory documents that they need to, using a digital signature verses couriering hard copy packages to all of these sites, and there are thirty or forty documents that need to be completed to even start a clinical trial. All of that workflow can now be done electronically. Those documents come back into the eTMF system electronically, once they are signed by the clinical trial site. They are maintained within the right section of the trial master file, so missing documents and auditability is much more efficient. That was one important solution that we launched in the fall of 2011, which had a significant impact on our sales. That was because people were starting to see how beneficial having that closed loop system was. I told you about that first because the process for which to configure an integrated clinical trial portal and eTMF typically took about six to eight weeks for us to configure for our clients. Every clinical trial has its own nuances and requires different configurations and workflow depending on the country you are working in, and depending on the type of study that you are doing. Therefore, the configuration for each study used to take six to eight weeks; sometimes up to twelve weeks, depending on what the study-specific needs were. What we have done over the last year is look at all of the best practices, all of the required workflows, permissions and document templates required in each country, and have built something that we call “one click configuration”. One Click Configuration allows us to select a set of pre-configured templates based on study metadata to configure an integrated clinical trial portal and eTMF, in less than ten minutes. Once that configuration has run, all of the right templates, permissions, documents, training modules and workflow for that particular study is ready to be used. A study manager can then make any study specific “tweaks” or changes that they may need to made, and launch the clinical trial portal, in a few hours. That really shaves off a lot of time for the set up of a study. What is helpful about this is that CROs are conducting over sixty percent of the studies right now on behalf of pharmaceutical companies. They need something that is fast to configure and scalable across their Sponsors to be able to derive the benefit. Some of these CROs are conducting two or three hundred new studies a year; that is twice as much as some of big pharmaceutical companies. Having a configuration solution like this is appealing to the CROs because they can now standardize the Sponsor templates and configure the systems in a very short time frame, and it is a scalable application can be used for five, six or seven hundred studies they might be conducting.
CEOCFO: How do some of the new healthcare policies affect or trickle down to what you are doing? What are your overall impressions, concerns and point of view?
Mr. Converse: The healthcare policies do not necessarily affect us as a service and software provider to the pharmaceutical industry and the clinical trial area. We are seeing some regulations that are changing, both internationally as well as with the FDA that are holding pharmaceutical companies and CRO’s to be more accountable from an auditability perspective. Therefore, solutions like these help them to stay compliant.
CEOCFO: What surprised you most as the business has developed?
Mr. Converse: The speed (or really lack of speed) at which pharmaceutical companies adopt new solutions is very surprising. I would have thought, after twelve years of providing eClinical solutions, that some of the pharmaceutical companies would have adopted technologies that enforce a more streamlined business process faster that they have. However, I think that is very difficult for them to do. That is the thing that probably stands up to me as the most “eye opening” revelation over the last ten years. I think that it is starting to happen now, just out of sheer need to start reducing cost and streamlining business process. However, it was not until three or four years ago that we saw any significant investment or major change in adoption of these technologies.
CEOCFO: What have you learned in previous experiences that is most applicable in this venture? Especially going back to your time at Boeing; is there anything from there as well that you can apply today?
Mr. Converse: People are your most important asset. We have got a tremendous team of people that are very, focused on our vision and love what we do. The people can have such an influence on the success of a company, regardless of whether you have great technology, or whether you have an interesting service; if you do not have people behind it that love what they do and share the same vision, it is very difficult to be successful.
CEOCFO: How is business at ePharma these days?
Mr. Converse: Good! We doubled sales last year. I believe we are on track for at the same velocity for this year. I do not want to predict that we are going to double sales again this year, but we have an incredibly strong backlog, and our pipeline looks pretty full, and we are starting to see significant adoption of our software from both pharma companies and CROs at the enterprise level. We are very pleased with how things are going.
CEOCFO: What makes ePharmaSolutions a special company? Why should investors and people in the business community pay attention?
focus on solving the major causes of study delay through niche services that
we provide and through a technology platform that is highly scalable, and
getting great adoption in the industry, evidenced by the sales improvement
that we have seen over the last couple of years. Also, because we are
having, probably to most significant impact on reducing the paper and manual
process of getting clinical trial sites activated and sites managed
throughout the lifecycle of the clinical trial. That translates into
tremendous cost savings for pharma companies, but also a reduction in
business process, which are more soft cost savings and a little harder to
quantify. However, we reduce a lot of double and triple data entry for study
teams. We reduce a lot of manual scanning and copying and paper processes.
It is like what
electronic data capture
was to our industry ten or twelve years ago, with
the reduction of paper for case report forms. We are doing that now with all
of the other paper forms and paper processes that are required. I think that
is the next step in the process of solving some of these problems for the
clinical trial industry. The outlook for 2013 looks very promising. We have
a very cool new idea that we are working on with about twenty major
pharmaceutical companies and five CRO’s, which is called the “Referral
Plus”. It is a novel concept that has not been thought of before. We are
just starting our pilot programs on about twenty clinical trials now. The
concept is that pharma companies typically run advertisements for patients,
and when patients respond to those ads they are directed to a call center or
online screener to see if they qualify. Ninety five percent of those
patients who screen do not get into the study they initially screened for.
The pharmaceutical companies, historically, have never done anything with
those patients. Pharma companies can pay up to two or three million dollars
for a central recruitment campaign; and ninety five percent of the patients
never ever get into the study they initially screened for. That is
unfortunate for the patients too, because they are motivated people who
probably need access to new medications or new therapies. To solve this
problem, we have developed a concept with consortium of pharmaceutical
companies who are interested in using our common screening technology to
screen and triage patients for all of the studies they are conducting. For
example, if Pfizer were to run an ad and a patient responded, our solution
can screen that patient for that Pfizer study, and if that patient does not
qualify based on their screening responses, the solution uses a
geo-therapeutic algorithm to match that patient to other company’s studies
they might qualify for. It is a very novel concept. We had a group of
pharmaceutical companies come up to Pfizer headquarters in New York in
December of 2012 to evaluate the notion of sharing patients who disqualify
from one trial with other each other’s active trials . Every one of them has
agreed to participate in the program. One of the senior VP’s who
participated suggested that this is the most interesting and innovative
thing that has happened in patient improvement in thirty years. This
concept of sharing patients would not have been considered years ago for
many reasons. However, if you think about it now, in today’s environment;
these pharma companies have established innovation groups and they are
collaborating much more than they were five or six years ago. If I would
have approached the VP of a pharma company and asked if they would be
interested in sharing patients with other pharmaceutical companies
they would have laughed at me. There has been a
major mind shift recently at the top fifteen or sixteen pharmaceutical
companies; every one of them has bought into the program. They completely
understand the value, not only from a cost saving standpoint; because you
reduce the cost from six thousand dollars down to four hundred dollars when
you take a patient and put them into a second or third study that they might
qualify for; but the benefit to the patient is significant as well. We have
recently partnered with CenterWatch to help us make this initiative a
success this. We are going to leverage the CenterWatch content and trial
listing capabilities with our screening and matching technology and the
pharmaceutical consortium to launch these pilot programs in the April May
timeframe. Then we should have production level implementations happening at
the end of the year, so we are pretty excited about that.
“The people can have such an influence on the success of a company, regardless of whether you have great technology, or whether you have an interesting service; if you do not have people behind it that love what they do and share the same vision, it is very difficult to be successful.”- Lance Converse
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