4
Apr

Glenn Keet Interviewed by Direct Recruiters

Sarah Pozek, Director of Life Sciences, Direct Recruiters, Inc., recently interviewed Glenn Keet, Chief Executive Officer of ClinCapure, a leading provider of cloud- based e-Clinical software (clincapture.com). Mr. Keet answered questions about his career, the Life Sciences industry, and his philosophies for hiring and retaining top talent.

Tell us a little bit about yourself and ClinCapture.

I had always been strong in math and science, and when I graduated with a combined degree of Mechanical Engineering and Applied Sciences, I assumed I would become an engineer.  But my first job out of college was with a software company, and I have been in software ever since.  I now look back on my engineering degree as good training for any career – it taught me problem solving and critical thinking; two skills I use every day.

It just so happens that I started in a software company that had healthcare and insurance companies as clients, so I was exposed to healthcare IT from the start.  Otherwise I might have ended up in any other software vertical.  But I am glad to have been exposed to healthcare IT, since at the time it was far behind other industries in the use of information technology and tools to be efficient and competitive, therefore there was great opportunity to make an impact.  I believe there still is.

Some would agree life sciences is even further behind its use of information technology, and this is because the highly regulatory environment has hampered adoption of software tools.  It is the reason I chose to come to ClinCapture, as I see the same kind of opportunity in life sciences now that I saw in electronic health records in the mid-1990s.

ClinCapture, located in Silicon Valley, is a software-as-a-service vendor of electronic data capture (EDC) software, serving those sponsor companies running clinical trials, such as medical device manufacturers and drug companies, along with the contract research organizations (CRO) that outsource the running of clinical trials for the sponsors.  EDC tools have been around a while, but have traditionally been used only by larger companies or larger trials – smaller companies or those running earlier phase trials have not had the wherewithal to deal with the cost and complexity of EDC software, and therefore use pen and paper or spreadsheets to collect data from their trials. ClinCapture aims to remove these barriers so that any size company or any phase trial uses EDC, and saves money in the process over paper or manual processes.  Ultimately, ClinCapture aims to take $1.6B out of the cost of running clinical trials worldwide over the next 5 years.

What fascinating projects are you currently working on? 

There are so many compelling stories in life sciences.  I have the privilege of hearing about promising, breakthrough therapies years before the general public hears of them. I also get to work on solutions to problems through our software, like incorporating direct patient feedback into trials, or connecting and integrating the medical records systems that physicians use with our data capture solution so they can use the same tool when seeing one of their patients that happens to be participating in a trial.

You have worked in life sciences/HIT for over two and a half decades. What or who do you attribute your success to?  Did you have a mentor(s)?

Mentors are important and helpful in taking you to the next level in your career.  I had the privilege to work with a couple people that helped me learn and grow in ways I wouldn’t have on my own.  At my first software job in the mid-1980s I worked for Connie Galley, one of the earlier female CEOs in the software industry, and she showed me the importance of getting close to clients.  And Ray Scott, co-founder of Axolotl, taught me management skills that you can’t learn in books.

How has the industry changed since you entered it nearly 30 years ago, and where do you see it going?

I think the biggest change in Health IT over the past 30 years is the feasibility of integrated products.  Thirty years ago, the integration of two products was more like a science project versus a standard or repeatable process.  Over the past three decades, we have seen the creation and improvement of both data standards (HL7, CDISC, RxNorm, etc.) and application interface standards (open APIs, IHE, etc.)  It is now very possible to create a solution of best of breed applications that far surpasses a monolithic, all-encompassing single vendor solution.  This speeds innovation, as vendors can specialize in areas, and end users can get the benefit of improvement in a variety of areas much more quickly.

What trends are you seeing in the eClinical area?

I have seen a few breaking through.  For example, the rise of eSource, which enables the capture and creation of clinical data in EMRs or other products, and how that will save time and money for data capture.  Also, ePRO, which are patient reported outcomes that enables the clinical trial to incorporate patient feedback into the data.  I recently co-authored a paper on this exact topic, which delves into much more detail on these and other trends.

Where do you see ClinCapture in 5 years?

With ClinCapure’s ability to remove virtually all the startup costs, and with our freemium platform, we calculate that we save our clients over $200,000 on average versus another EDC system.  And probably more than that for those that would use paper due to the inefficiencies and errors, and then the additional manual labor if they intend to submit the results to the FDA or another country’s regulatory body.  Therefore, our goal 5 years from now is to have taken $1.6B out of the costs clinical trials, allowing that money to be put to better use, like finding therapies.

Besides just EDC, ClinCapture is positioning itself to be a whole eClinical platform.  With open APIs, we hope to have many partner products on our platform that are pre-integrated for our clients, making the applications share data seamlessly.

How do you retain top industry talent?

One of ClinCapture’s strategic initiatives is to attract and retain the right people for our organization.  In order to achieve that, we have set goals to offer competitive salaries, stock options for most employees so they own a part of the company they work for, and career planning so that we are sure our employees are working towards their own career goals.  Besides compensation and advancement, however, it is equally important that staff enjoy their time at work.  We have a culture of work hard/play hard, and our team gets along like a big family.

Glenn Keet has worked in health care IT for almost three decades, and since May, 2014 has been CEO of Clinovo, Inc., now named ClinCapture, a leading vendor of cloud-based EDC software that serves entities engaged in clinical trials.  Prior, Mr. Keet was SVP over Business Development on the Optum Health Care Cloud, focusing on developing the ecosystem of providers, developers and consumers.   

Mr. Keet became part of Optum via the acquisition of Axolotl Corp., which he co-founded in 1995 and where he was President.  Prior to his role as President, Mr. Keet had been head of Sales and Marketing, Business Development, and Professional Services.

In the first half of the 1990s, Mr. Keet held managerial positions for Mercator Software, now owned by IBM. Mercator sold general purpose EDI and HL7 mapping and translation engines used in health care, insurance and other industries.

Mr. Keet graduated from Lehigh University in 1986 with a BS in Mechanical Engineering and BA in Applied Sciences, and later attended Wharton’s Executive Leadership program.  He has two teenage sons, and resides in Santa Cruz, CA.
Glenn.keet@clinovo.comwww.linkedin.com/in/glennkeet, 813-234-6653.

By Sarah Pozek, Director of Life Sciences, Direct Recruiters, Inc.,

10
Mar

Top eClinical Trends in 2016 (2/2)

This article is the second part of our white paper: Top eClinical Trends in 2016. Read the first part here. Please visit clincapture.com/papers to download the full report and access more white papers.

T.-Taricco - PRC - ClinovoGlenn Keet is CEO at ClinCapture. He has worked in healthcare IT for over two and a half decades, and most recently was responsible for Business Development on the Optum Health Care Cloud, focusing on developing the ecosystem of providers, developers and consumers. Mr. Keet became part of Optum via the acquisition of Axolotl Corp., where he was President. He co-founded Axolotl in early 1995. Prior to his role as President, Mr. Keet was EVP over Sales and Marketing, responsible for all HIE sales to states, RHIOs and hospitals. Glenn Keet has previously held the role of VP of Business Development, and also has served as VP of Professional Services. He was the company’s Product Manager until 2001.

Changes in RBM Trends 

Recent trends in risk based monitoring (RBM) were discussed at the November 2015 CBI Conference on risk based trial management. RBM is the practice of saving time and money by reviewing or verifying only a portion of the source documents, those most likely to have the greatest potential to affect the study data.  Among the topics were the changing roles of study monitors, as well as the way RBM is changing how clinical trials are conducted. Even though some CRO and sponsors aim for 100% SDV, the path to RBM has been forged with many new technology companies addressing RBM in the last couple of years.

Recent trends indicate that sponsors are more comfortable than ever outsourcing source data verification and monitoring visits to CROs. However, they now prefer to insource Clin Ops and data management so they can have more real-time control over the study, and mitigate any fallouts as they happen.

The FDA recently developed a risk-based site selection tool which collects NDAs by clinical investigator sites and allows the agency to use the stratified data in order to select sites for GCP inspections [9].

Experts point out that as more companies employ RBM, clinical trial teams should differentiate between clinical data supporting safety endpoints, efficacy endpoints, protocol endpoints, performance, and general study management [10]. The value of RBM would not be leveraged if all data would otherwise be treated equally instead of being classified.

Another useful piece of advice is to pay attention to data trails and the changes made, having 100% QC on any modifications. The recent trend in higher RBM adoption has adapted the monitoring role to keep track of any changes the study team and sites are making. Experts say that is the way for people, processes and technology to complement each other when using RBM in a clinical trial.

eConsent Adoption

The FDA defines electronic consent as “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent” [11].

There are several eSignature and eConsent systems currently available on the market. In addition, companies such as Apple are also entering the medical research market with apps and wearable technology. For example, Apple’s ResearchKit has a module for building electronic consent forms.

A recent survey of the top 50 pharma companies shows that about 66% of them are either using eConsent or planning to in the near future. The percentile is even higher among the top 25 companies on the list- 88% of them have implemented eConsent. 100% of the top ten companies have also put eConsent initiatives in place [12].

ePRO to Replace Paper Soon 

Technology is also placing the patient at the epicenter of clinical research, particularly with electronic patient reported outcomes (ePRO) systems allowing patients to report clinical trial data themselves. The modern ePRO systems are designed to maximize the ease with which patients report their observations. Additionally, they better integrate with eClinical systems to capture and direct relevant clinical data faster to clinical teams. ePRO systems integrate with electronic data capture (EDC) systems to automatically and securely import clinical data from the ePRO directly into the EDC system. This allows a quicker response time in the case of adverse events, for example.

In a recent survey, examining 22 sponsors and CROs, 18 reported having adopted ePRO which resulted in increased data quality, patient compliance and efficient data collection. 61% of the surveyed companies indicated they implemented ePRO in the last five years, 28% in the last 10 years, and 11% over 10 years ago [13]. Experts say the increased emphasis placed on patient reported outcomes and the push for technology adoption in clinical trials has resulted in significant increase in ePRO utilization. While the Tufts survey points out there’s been an overwhelming increase in ePRO usage in the oncology field, the main drawback cited has been the cost of using ePRO as compared to paper.

Yet, it has long been known that ePRO improves the quality of the patient reported data over paper systems or diaries; patients, being human, often don’t write down their notes as they should each day or in a timely manner. Not only can ePRO systems remind patients to record their notes, but can also track whether the patient created all their entries at once just prior to the next site visit, as is often the case in the paper world (aka the parking lot syndrome).  The higher ePRO adoption trend is likely to continue as more companies see its value for post-marketing trials, as well as its benefits and expanding capabilities as new vendors add systems each year.

eClinical Integration

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management during the product’s life cycle includes investigators, regulators and patients; requiring systems integration to ensure data is accurate and consistent.

Leveraging technology to optimize speed, quality and cost of clinical trials is a big hurdle for pharma and their CRO partners. Bringing drugs and medical devices to market faster is most important for business success. CROs are quickly realizing that in order to remain competitive, they need the IT infrastructure to accommodate an influx of clinical data that would be well-organized and easily accessible from a central repository.

This repository should handle the integration, reporting, management, visualization and analysis of all clinical data. For example, an integrated system, comprised of custom CTMS, Pharmacovigilance, EDC and a CDISC-compliant data warehouse enables the timely analysis of clinical data. Traditional integration between electronic data capture (EDC), clinical trial management systems (CTMS), clinical data repositories (CDR), clinical data management systems (CDMS) and statistical analysis systems (SAS) may require a lot of manual data tranformation. While many sponsors can afford to transcribe data in the right format before sending it to their CROs, smaller companies still struggle to prepare their data for FDA submission.

That is why integration is crucial for both clinical trial sponsors and CROs to exchange data during all trial phases. Big pharma reportedly spends close to $200 million annually for data transfer. But new trends are emerging to combat the old ways of not transferring data until all collection is done. More and more trials are now conducted with the data moving earlier during study conduct. This method allows managers to spot and ferret out potential problems, thus saving money and time. Another trend which saves time and money is following the CDISC’s (Clinical Data Interchange Standards Consortium) CDASH (Clinical Data Acquisition Standards and Harmonization) data standards for collection fields. This saves companies from not having to restructure their data in the drug-approval process. CROs must also follow data aggregation formats such as STDM (Standard Data tabulation Model).

Whether you choose EDC & CTMS, eTMF & Safety, or EMR integration, there is no one-stop-shop solution. For example, CTMS solutions such as Advanced Clinical Software’s Study Manager have been installed at over 2,000 sites but there are still no defined metadata and communication standards that allow CTMS and EDC solutions to share data. Many EDC systems have incorporated tools that render CTMS unnecessary for less complex trials, but a common issue with EDC-CTMS integration occurs when there are complex investigative site business practices. Many EDC systems only capture clinical trial data through eCRFs that lack CTMS information. Another issue is that some EDCs may lack timeline planning features such as reaching target subject recruitment milestones. As for eTMF & Safety integration, a common issue is the lack of real-time inspection and ICH/GCP compliance.

One way for improving this process is to focus on data analysis, not just warehousing it. Most companies only focus on front-end integration without considering the need to generate reports for regulators later. If data were integrated from the start, it would be easily accessible at any point. However, this is easier said than done, as implementing systems integration can typically cost $500K and take as much as 3-6 months, which can eat up a significant chunk of the research budget.

Collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems or modules, shows that the value of integrating will only continue to grow as users see the efficiency in storing and viewing their data on a single interface.

CDISC Standards Mandate Affecting U.S. and Japanese Submissions

Last December the FDA published a landmark package of Guidances, specifications and other documents governing electronic submissions. These have the force of law, which in effect made the use of CDISC standards mandatory in the United States and Japan by December, 2016 [14].

The FDA Guidances establish the framework for the requirement of standardized study data in submissions, and cover most aspects of submission data and documentation.

The new mandate increases pressure on CROs and sponsors to conform. In addition, the FDA is also considering updating the CDASH standards, which would also have a significant impact on current clinical trial processes.

Clinical Trial Paradigm Shift

A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” in 2015. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this patient-powered research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients [15].

The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) [15].

The objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June 2015, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation [16].

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research.

The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will also include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework.  As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

Conclusion

Although late to the game as compared to other industries, the clinical trial industry is now embracing information technology at a much greater pace.  New and improved software applications and systems are being deployed at increasingly higher rates.  Sponsors and CROs are adopting EDC, ePRO, CTMS, eTMF and other systems faster than ever, as the benefits have been proven to far exceed the expense and the FDA and other regulatory bodies are mandating electronic data submissions.  Usage of these applications and systems will continue to improve the quality of data being collected, reduce the overall costs of clinical trials, and speed new drugs and products to patients.

 

By Glenn Keet, CEO at ClinCapture
And Eric Morrie, Director of Product Operations at ClinCapture

Please visit clinovo.com/papers for more white papers by Clinovo. 

Sources:

[10] Changes in RBM Trends: Interview with Former FDA Officer

[11] Use of Electronic Informed Consent in Clinical Investigations

[12] Electronic Consent Management: Landscape Assessment, Challenges and Technology

[13] Tufts CSDD Study of ePRO Usage in Clinical Trials

[14] Electronic Submissions- The Requirement for Standardized Study Data

[15] White House Precision Medicine Initiative

[16] Fact Sheet: President Obama’s Precision Medicine Initiative

 

12
Jan

Can You Afford Not To Go Electronic? (Part 2)

Selling EDC to the Checkbook Holders

If your company should be using EDC but isn’t, how can you help to seal the deal? Case studies are always helpful, as they can provide examples of the savings that can be realized. It may seem free or cheap to use paper, but you need to get management to look at the cost of increased labor time when using paper vs. EDC (data entry, query management, etc), as well as to evaluate the cost of using that data later or how errors and corrupt data can affect the study. When you use EDC the total costs always end up being significantly less, and those savings will compound when doing additional studies.

Some people will always resist new technologies simply based on risk/reward and the return on investment. But those arguments are getting easier to overcome as the costs of an EDC implementation head towards zero. Rather than taking three years to recoup an initial investment, companies are now able to do it in a week. You can now start a trial, build your CRF on the vendor’s system, add complex rules if necessary, and do all of that for free or a very low cost. The labor it will take to do that is also significantly lower than the labor it would take to manage it on paper. Taking that kind of a proposal to management is almost a no-brainer because in many cases you won’t even have to ask for a check. It is no longer a funding issue. It is a data quality and efficiency issue. There are really no longer any reasons for someone not to go electronic.

A Look into the Future

In ten years I envision for every study, key personnel signing into a single secure system, looking at trial documents and the trial management system, checking up to the minute total spending amounts, and viewing real time outcomes and analytics data from studies in progress. This view into the data will allow them to know much sooner in the process whether and when a study should be cancelled. This will potentially save companies millions of dollars and allow them to focus personnel and other resources into trials showing the most promise. The seamless integration of applications on an open platform and providing secure access to the collected data by any of the programs will be inherent in the system.

All of that information will be on a dashboard and available to approved personnel at the touch of a finger. This is actually not that hard to do in a cloud environment with open APIs and where developers can build applications on robust platforms. When you start attracting people to a new paradigm and hit a critical mass of users and data, it suddenly becomes worthwhile for developers and companies to enable other applications on it. That is something we will continue to try to make into a reality.

Finally, it is important to note that technology is not at a standstill. In the last 10 years we have seen significant changes in technology. Going forward, we will continue to see new technologies hit the market. Smart phones and tablets will continue to play a greater role in clinical trials for mobile and off-line data entry. An explosion in wearable monitoring devices such as sneakers, wrist bands, and even clothing, in addition to things like web-enabled scales, will continue to be a strong lure for both consumers and clinicians. I believe the quantities of data generated and gathered will be much greater, making it a crime for life science companies to not take advantage. Unfortunately, for that to happen, regulatory agencies will also have to figure out how to best make those devices a part of the trial process.

Right now you can’t use invalidated devices in a trial, which I believe will lead to some interesting debates. If you’re doing a study on diabetics who need to weigh themselves every day, will they be able to get on their web-enabled scale that will automatically upload their weight into a system or are we going to have to go with the less robust method of them reporting their weight by paper or by phone? Will we get accurate weight data or have to continue to worry about patients making up the numbers or not performing the weigh-ins at the proper times? Technology can alleviate those situations and deliver better data, but we need the regulatory agencies to step up and make decisions on what will and will not be allowed.

Glenn Keet, CEO at Clinovo

Download the full white paper by clicking here

5
Jan

Can You Afford Not To Go Electronic? (Part 1)

With the technology advances we have seen in the last 10 years, and changes that we continue to see every day, it’s hard to believe that, worldwide, only around 20% of clinical trials are using electronic data capture (EDC). The other 80% of data is still being captured on paper or in Excel spreadsheets. With any luck, in ten years we will see 99% of trials capturing data electronically. Many changes are occurring which will enable that to happen, but life science companies will need to educate themselves on the changing landscape.

Of course the first question you have to ask is why the low adoption rate. The answer lies in perceptions about the cost and complexity of migrating to EDC. Barriers that existed in the past could generally be navigated by large pharma companies that had the money and manpower to overcome them. For startup life science companies, it was a different story. They did not have the knowledge, the resources, or the budget to move to electronic trials. The situation has now changed, and the reality is that it is almost always cheaper to capture data electronically than to do it only on paper. However, misconceptions still exist in the market. Going forward, education and better access to available tools will allow them to take advantage of EDC as well.

Lower Cost, Greater Ease of Use

Cost is the first factor that will help the industry get to the 99% acceptance rate. In the past, the price of an EDC system varied widely, but you always got what you paid for. If you purchased a cheap system, you generally found yourself lacking in features. That forced companies to purchase more expensive systems to get the functionality they needed. The advent of the Internet and cloud capabilities has changed all that.

EDC software with the same capabilities as the more expensive systems has come down in price dramatically. In some cases, the software is even free. This has happened for two reasons. The costs for supplying cloud software are far reduced from the traditional licensed delivery model that existed in the past. Today we also have a validated regulatory environment in the cloud, whereas in the past companies had to establish their own data center and validate it at a high cost. All of this is causing a dramatic drop in the initial entry cost (the license and startup cost) for starting a trial.

In addition, new tools have been emerging that allow companies embarking on trials to do a lot of the work themselves. In the past pharma had to pay a CRO, software vendor, or other professional services provider to perform functions such as changing case report forms from paper to electronic. The trend now is to provide free or inexpensive software along with do-it-yourself capabilities that allow even small companies to do much of the work themselves. In most cases it costs less than doing the same work on paper.

Driving Adoption in Pharma

Even with the cost benefits, the conservative nature of pharma means most firms won’t be lining up to implement new systems. In bigger pharma companies, buy in will generally occur at the management level and then get driven down into the company. In smaller companies, the growth of adoption will likely be more organic, as those companies will not be able to afford not to do it. As they adopt the most cost efficient technologies and most economical methods, their actions will likely drive greater adoption in the larger companies that are traditionally more stuck in their ways. To put it simply, the larger companies should be doing it, but the smaller companies will have to do it.

There will certainly be a role for CROs to assist with the adoption of these technologies as well. Sponsors will often tell their CROs how to perform studies and what tools to use, but more and more CROs will implement technology advances on their own in order to better serve clients. If a CRO is making use of a cloud-based technology that is free of charge, they can pass those savings on to the sponsor. With CROs responsible for about 50% of studies in the U.S. alone, those changes will obviously have a huge impact.

Glenn Keet, CEO at Clinovo

Download the full white paper by clicking here

25
Sep

EMR and EDC Integration

It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.

The challenges include:

  • Low adoption rates of EMRs in physician practices
  • Lack of interoperability tools provided by vendors to extract data from EMRs
  • Lack of standardized payload (content) and method of delivering (transport) from different EMRs to the EDC systems
  • All subjects of clinical studies not being part of the same health system and therefore same EMR
  • Lack of automated methods for identifying the same patient between EMRs and EDC systems
  • Inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems

These hurdles have been so high that the task has rarely been attempted in earnest, let alone accomplished in any significant way.  That is until recently.  How are these challenges being overcome today?  What changes have allowed this integration to be to considered and implement today? The answer is: lots!

EMR Adoption Rates
EMR adoption rates in physician practices rose slowly but steadily in the early 2000s. Although aware of EMR’s advantages, the high startup and software costs, unavoidable upheaval in their practices, and the costly conversion of historic paper records, conspired to keep EMR adoption low.  Then came Obama’s HITECH that paid physicians to achieve “meaningful use” of EMR, which gave explosive growth to the market. Adoption rates soared from single digits to over 60%.  HITECH also incentivized hospitals to achieve meaningful use of their EMRs, and required certification of the systems’ capabilities, which caused a rush for vendors to improve their systems, and hospitals to upgrade to newer versions. In the past few years both physician practices and hospitals have been rapidly adding or upgrading their EMR systems to be compliant with HITECH rules.

One certification requirement of ‘meaningful use’ is interoperability which requires both the physician practice and hospital EMRs to be able to export and import patient medical records using a common, standardized format. The EMR industry first converged on using CCD, or the Continuity of Care Document, which provided a ‘snapshot in time summary’ of a patient’s health record.  However, the C-CDA (Consolidated Clinical Document Architecture) emerged as a bigger container, using CCD as just one section, or embedded document, of clinically relevant information.  Other sections include Discharge Summary and Consultation Note. The C-CDA specifies what information is mandatory for which use cases, and specifies the structure, format and content of the data, including use of the appropriate coding dictionaries for each kind of data. All recently certified EMRs against Stage II of Meaningful Use rules must be able to import and export patient records in this format.

Another part of HITECH incentivized the exchange of these records through safe and secure use of technologies. This was created by establishing funds for creating statewide Health Information Exchanges (HIEs), as well as interstate exchange through protocols for the Nationwide Health Information Network (NHIN).  Although HIEs existed prior to that, they were generally just local or regional, and worked differently.  Most used HL7 as the standard for both payload and transport, but the implementation of the HL7 interfaces varied widely. With HITECH, the explosion of HIE deployments caused the coalescing of standards for querying and delivering of patient medical record data.

Unfortunately, it is very time consuming for HIEs to establish and gain traction. The government was in favor of interoperability of EMRs but was unable to wait for all HIEs to begin functioning.  Moreover, not all data transport was limited to state borders, so interstate exchange was necessary.  This fomented the creation of the Direct Project, a simple subset of HIE functionality that enabled point to point delivery of medical records over the existing standard internet using the equivalent of secure email technology for transport. Using Direct, with the patient’s permission, a physician could “email” his/her record to another registered physician without breaking HIPAA regulations.  Additional use cases emerged, such as laboratories using Direct to send diagnostic results into an ordering physician’s EMR. Many vendors have come to offer solutions for Direct, including the certification process for registering the physicians, the physician directories of registered users, and the secure messaging software tools. It is an inexpensive solution and enables physicians to collect their meaningful use incentive payments, and adoption rates are beginning to climb rapidly.

What about the EDC systems?
Some EDC system vendors have been making their products more standards-based and interoperable despite the lack of similar government incentives that the EMR vendors had.  For example, data dictionaries are now being used to ensure fields inputted in CRFs are uniform and reusable. This enables mapping and translation of data being imported to, and exported from, the CRFs. Additionally, the use of standards has increased.  IHE, the overseer of the C-CDA standards, also include formats for Clinical Research Data Capture (CRD) using both CCD standards as well as CDASH (the latter being more common in the EDC world today). EDC systems that support CDASH and reusable CRF libraries are well positioned to accept or exchange patient data with EMRs.

What does this all mean?
Let’s imagine a clinical study where there are 5 sites in the U.S.  At each site there are about 30 patients enrolled, each not necessarily associated with the same hospitals or the same physician practices. Their varied insurance plans ensure that multiple laboratories will be involved for the required blood and other sample diagnostic work at each site. Up until recently, it would have been impossible to succeed in integrating this with an EDC system; and any attempt to do so would have been costly, time consuming, and complex. Yes, it may have been possible for a custom interface between one of the EMRs and the EDC system, but likely that would have only helped with a subset of the enrolled subjects.

Fast forward to 2014. It is possible that all 5 sites will be in areas where robust HIEs exist. If so, many of the physician practices and hospitals will have their EMRs integrated to the HIE, and will be able to exchange data in standardized formats. Connecting additional systems to the HIE is straightforward. For those practices not participating in the HIE, their certified EMRs can deliver data via Direct Project protocols to other physicians and systems. This means that it is likely that most, or all, of the patient’s enrolled can have their existing and future medical records part of the study.

The study is using a modern EDC system. The CRFs are CDASH compliant, and so data being captured in EMRs can easily be inherited into the study, speeding the process of data capture and reducing errors. Electronic transaction logs make it straightforward to audit the source data and data received into the CRFs is already coded (medications, immunizations, allergies, problems, procedures, diagnostic results, etc.) in standard formats so that it can be understood by the systems and actionable.

Today, it has become more cost effective to integrate data from HIEs or EMRs. The costs of duplicate entry and the associated errors are higher than the costs of establishing the interfaces to the external systems. There are many use cases for EMR data integration with EDC, and one size does not fit all. We at Clinovo are interested in the use cases you have, or foresee similar, to this integration, and welcome any dialogue or feedback.

Glenn Keet, CEO at Clinovo

 

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16
Apr

CDISC Standards: Five Implementation Strategies

I was very glad to present at the CDISC Interchange Europe 2014 this month in France. This renowned conference was held in Paris, France on the 7-11th April 2014. I consider it as a premier venue for clinical trial experts dedicated to implementing and spreading the use of FDA-recommended CDISC standards.
I explained in my presentation how to prioritize the different steps to implement CDISC Standards, from CDASH CRF designs to succeeding in an FDA Submission in the SDTM format. The presentation focused on five strategies suited for medical device companies to effectively adopt CDISC Standards.

Clinovo has always been a strong proponent of adopting CDISC standards. I recently moderated a panel discussion on CDISC for medical device companies, with Carey Smoak, CDISC Medical Device Team Leader. Feel free to also catch up with the audio extracts of the talks!

Ale Gicqueau, President & CEO at Clinovo

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1
Apr

Clinovo Event in Mumbai, India Organized by Partners Krishagni & JCDC

As some of our blog readers may be aware, I recently traveled to India to meet our trusted partners and to explore opportunities for our open source eClinical systems. I am very grateful to our partners Krishagni & JCDC, who spontaneously organized an event for us to showcase both ClinCapture & CDISC Express. The event took place at the Marriott Courtyard near the airport in Mumbai, an area with over 30 CROs and many life science companies in the neighborhood.

JCDC

The event was scheduled to start at 10am, but when the time came it was just myself, colleague Sanjay, and 3 other attendees. However, by 10:30 AM thing were in full swing with 22 people in the room listening to our presentation; what a fantastic place to do business development! It was a joy to meet our first ClinCapture client in India - it turns out all of their sites are in the UK, one the next stops in my travels this month. We met several other companies including CRO Criterium Clinical Research India who is about to adopt ClinCapture, the Head of Medical Affairs at Boehringer Ingelheim, the General Manager of Clinical Research of Bharat Serum and Vaccines, the Head of Clinical Operations at Abbott and too many more to mention!

zifoWe had a captive audience; they were extremely interested in our open source technology, particularly the advanced features we’ve been releasing in ClinCapture, and they had very good questions. Put briefly, the event really was a big success and I’m extremely grateful to both Krishagni & JCDC. To finish the day, with the help of our new board member Jawad Khaki, I got an introduction to TCS (Tata Consulting Services). TCS has 300,000 employees across the world as I was able to I speak with their Head of Clinical Services Ganesh Parkar as well as Sanjina Almeida (former chair of SCDM).

All in all it was a fantastic week in India, and while I was out here to meet Clinovo partners, it felt as though I was spending time with friends. I’m very excited to see how the Indian market grows over the coming years.

Ale Gicqueau, President & CEO at Clinovo

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1
Apr

Clinovo Event in Mumbai, India Organized by Partners Krishagni & JCDC

As some of our blog readers may be aware, I recently traveled to India to meet our trusted partners and to explore opportunities for our open source eClinical systems. I am very grateful to our partners Krishagni & JCDC, who spontaneously organized an event for us to showcase both ClinCapture & CDISC Express. The event took place at the Marriott Courtyard near the airport in Mumbai, an area with over 30 CROs and many life science companies in the neighborhood.

JCDC

The event was scheduled to start at 10am, but when the time came it was just myself, colleague Sanjay, and 3 other attendees. However, by 10:30 AM thing were in full swing with 22 people in the room listening to our presentation; what a fantastic place to do business development! It was a joy to meet our first ClinCapture client in India - it turns out all of their sites are in the UK, one the next stops in my travels this month. We met several other companies including CRO Criterium Clinical Research India who is about to adopt ClinCapture, the Head of Medical Affairs at Boehringer Ingelheim, the General Manager of Clinical Research of Bharat Serum and Vaccines, the Head of Clinical Operations at Abbott and too many more to mention!

zifoWe had a captive audience; they were extremely interested in our open source technology, particularly the advanced features we’ve been releasing in ClinCapture, and they had very good questions. Put briefly, the event really was a big success and I’m extremely grateful to both Krishagni & JCDC. To finish the day, with the help of our new board member Jawad Khaki, I got an introduction to TCS (Tata Consulting Services). TCS has 300,000 employees across the world as I was able to I speak with their Head of Clinical Services Ganesh Parkar as well as Sanjina Almeida (former chair of SCDM).

 

4
Feb

2014 Trends: Will the Cloud benefit Big or Small pharma? (2/3)

The “Cloud” gives the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility, and cost-efficiency never seen before. In other words, the Cloud is the idea that you can use a service on-demand, as and when you want, and pay for what you use and only what you use. Simple.

Leveraging the Cloud for the drug development industry

It is becoming critical for the drug development industry to adopt new methods to deal with the ever-growing flows of clinical data; Industry analysts estimate that the data generated by the pharmaceutical industry doubles every six months. However, the drug development industry is still in the early stages of evaluating the applications of Cloud in its field.

One of the first applications to come to mind is the use of cloud computing to capture and manage patient’s clinical data across large clinical studies. Many foresee the emergence of “Cloud Data Capture” gradually replacing Electronic Data Capture (EDC), among other eClinical systems.

Big Pharma will adopt Cloud technologies for the scalability

In the Cloud, data is available in real-time from anywhere in the world, and the rapid elasticity afforded to cloud-based hosting solutions can virtually offer infinite scalability. Users are able to expand the volume of memory or bandwidth needed in a just a few clicks without having to rely on IT or knowing any programming. Thus it becomes logical for Big Pharma to look into Cloud technologies as these beneficial features correspond directly to the issues they face. In July last year, FierceBiotech reported that in 2013, Pfizer was pushing the use of Cloud computing for supporting an online clinical trial system developed internally. It should be noted here that many believe it is in the best interest of the Pharma industry (as big as they are) to rely on external vendors as far as novel eClinical technologies. Unsurprisingly Pfizer has since abandoned the project.

Small Pharma will go after cost-savings and usability

The Cloud is also of great interest for small to mid-sized biotech, medical device companies, as well as universities. The introduction, and growing adoption, of Cloud technologies for clinical trials is also bound to lower the cost of technology and thus the barrier to entry.

Considering that the adoption of Electronic Data Capture (EDC) systems has remained slow in a number of segments of clinical research (only 40% of Phase I clinical trials had adopted EDC by the end of 2012) we can argue that there is a long-lasting barrier to entry for EDC. It could be argued that this is almost certainly due to the cost of acquisition for the majority of systems on the market and the complexity and changes required in technology. Cloud service providers for the pharmaceutical industry need to tackle this challenge, and make technology available and affordable for smaller companies, where resources are limited but where innovation blossoms.

Ultimately, it is my belief that the Cloud will revolutionize healthcare by enabling pharmaceutical companies to bring their drug to patients faster at a lower cost. I look forward to seeing if the year 2014 will confirm our prediction!

Thank you for reading! See you next week to read “2014 Trends: New Pathways to Sponsor-Vendor collaboration (3/3)”

Read 2014 Trends: Patient-centered clinical studies(1/3)  here.

Ale Gicqueau, President & CEO at Clinovo

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4
Dec

Entrepreneurs: When all odds are against you, believe.

The most important quality of any entrepreneur

I attended an event organized by Georgetown Angels in Menlo Park, CA. They are a new angel group with very interesting concepts they identified by understanding some of pitfalls of other US angel groups. I had a good chat with one of the founders, Andrew Romans, who seemed happy to be able to practice his French on me, all of which he had learned between the ages of 16 and 18!

This event was a traditional Silicon Valley angel group meeting hosted at a top 5 law firm with networking, a few investors, and lots of entrepreneurs and service providers. The companies that presented were top level but, to me, the highlight of the evening was the firechat conducted by Andrew with Pandora co-Founder Jon Kraft. His story was a testimony once again that the most important quality of any entrepreneur is the power to believe even when all odds are against you. I had assumed that the story of Pandora was one of a few smart kids with a cool idea who made a few billion dollars even while the company never made a profit. Well, my preconceived ideas were slightly off the mark!

If you get offered the money, take it

Jon doesn’t fit the stereotypical entrepreneur mold. My first impression was that of an introvert engineer but as the chat progressed, I realized he is a truly remarkable and fearless entrepreneur. In fact, Pandora wasn’t actually created in 2005, but in the middle of the dot com euphoria. After a good exit at Informix, Jon wanted to do something different and got the novel idea for Pandora with his co-founder. One of his past connections offered him $1.5M to get started based solely on his name, without even showing any interest in what the business was. Feeling a little bit embarrassed, Jon said he would take half of the money to show him a prototype before taking the other half. He said this was one of the biggest mistakes he ever made! A lesson learned, when you get offered the money, take it. Unfortunately, the dot com bubble burst, coupled with drastic changes to the music industry after the implosion of Napster.

Working through pitfalls

It was humbling to hear the hardships that had been experienced by an entrepreneur that had not only had such a successful first exit, but had also become the co-founder of Pandora, one of the most successful Internet companies of the last 10 years. They had a team of about 14 people and for 2 years were always out of cash. They were unable to process payroll once every 2 months and would then receive $50K or $100K to tide them over, only to run out of money again. Remarkably however, during this time they lost only 2 employees. Jon was very much exposed personally.  He had already stopped paying himself for a while and this was putting some hardship on his marriage however kudos to him as he is still married to his wife to this day! He experienced rejection over and over by investors of all kinds including VCs and angels alike. He said he would get one yes for 100 no’s, but he kept going. Of course there were moments of discouragement and I asked him what kept him going. To him, it was a combination of the early investors that believed in him, the users who loved the product, his co-founder showing amazing tenacity, and his personal exposure that left him no choice but to fight it no matter what was thrown his way. He left no space for fear or negative anticipation, as he had to give everything he had for the people that supported and believed in him.

Letting go of all fear

Another profound thing Jon said is that he did not care about dilution. This meant he was so committed to the business that to an extent he had let go of any personal desire for profit and, in a sense, had become selfless. His only commitment was to the business, his investors, and his customers and I suspect this is how he was able to let go of all fear. This might sound like a strange concept so let me explain. Fear of failure mostly stems from protecting the illusion of the limited self. We are afraid to fail because we are afraid to be judged, ridiculed or, at the core it all, feel unworthy of love. In his entrepreneurship journey, Jon had become the love from his investors, users, co-founder, his 2-year old daughter, and from his perspective, and in that space, there could be no fear. Jon, thank you for inspiring me that night in my own journey of entrepreneurship.

The product speaks for itself

Let’s finish on a funny anecdote. For every VC Jon pitched Pandora to, he would give a free trial of Pandora for them to check out the technology. Most of the time he would be rejected after his pitch and would subsequently cancel the free trial. More often than not, a partner would call him back to understand why the service he had started to be addicted to had been cut. Jon would explain that it was no longer necessary because they had decided not to invest. The VC would then explain it was the fault of a senior partner, economic climate, or other form of excuse and beg to bring the service back. This was the sign of a great product, and the affirmation Jon needed, despite his many setbacks.

Ale Gicqueau, President & CEO at Clinovo

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