29
Jan

Millennials in Research: New Ideas to Think, and Run Your Studies

Guest blog from prcclinical.com

T.-Taricco - PRC - ClinovoTony Taricco co-founded PRC Clinical in 2003. As the President and board member, he is responsible for the general business operations and finance activities, as well as human resources, and clinical payment services.Tony spent 20 years in Workers Compensation Insurance, starting as a Claims Adjustor for a small company of 25 employees and growing with that company to the position of Vice President and a staff of nearly 300. Tony’s business degree and extensive practical experience in business growth brings together the unique perspective of understanding the values and challenges of a small business and molding those into a strong foundation for long term expansion.

Recruiting for clinical trials is notoriously difficult and social media sites like Facebook and Twitter are being used to even out the odds. But it took a 21-year-old worker to come up with the idea of pitching a trial on Snapchat. The clinic signed up a participant the same day. “That was an eye-opener for me,” said Dan Sfera, a consultant to research clinics. He wouldn’t have thought of Snapchat, an app favored by teens and 20-somethings. Sfera is only 34.

FUTURE LEADERS

The story is just one example of how millennials, the generation born roughly between 1980 and 2001, are making their mark on clinical trials. As digital natives at ease with social media, they are helping companies find faster, less expensive and better ways of operating.

Already the majority of the staff coordinating and handling day-to-day tasks involved in clinical trials are millennials,according to James Denmark, founder and CEO of myClin Clinical Research.[1] They might be handling operations entirely at some small sites.

“If you fast-forward about five years, you’re going to find that almost all of the field research is being performed by the millennials,” Denmark said during a video conference to discuss the report, “I’m the Millennial That Is Running Your Clinical Trial.”[2]

Another 10 years and they will dominate the entire ecosystem, Denmark said,[3] estimating that millennials already represent 73 percent of the clinical trial-related workforce.

The percentage may not be surprising given that more than one-in-three U.S. workers today is a millennial. But it may be more surprising that this year millennials surpassed Generation X (the age group that most of upper management in the clinical trial industry fit into) to become the largest share of the country’s workforce, according toPew Research Center analysis of U.S. Census Bureau data.[4]

DIGITAL NOMADS

Predictions are always tricky but ignoring them risks eliminating a major pool of employees and tomorrow’s VPs. Millennials — those running clinical trials as well as those participating in them — are having an effect on the industry that reaches into their structure. Clinical trials are marked by a series of complex, rigidly defined steps and regulations. In contrast, the millennial generation has been raised on the legends of tech startup founders who became billionaires largely on their own terms. The result is a generation with a low tolerance for unfriendly processes and systems.

They believe clinical trials should be centered around what matters to patients rather than solely what is of interest to the people behind the studies. They also tend to be uncomfortable with rigid corporate structures and reject information silos. And they have a reputation for being self-starters. But they expect constant feedback as they try to advance quickly up the corporate ladder during a varied and interesting career at multiple companies.

Technology is helping to drive these expectations. Millennials are the country’s first “digital natives.”[5] In other words, they are the only generation so far which has not had to adapt to new technologies. Being digital natives means millennials are used to getting the information they want when they want it and from a multitude of sources such as social networks, rating websites and word of mouth referrals, according to MD Connect, a digital medical marketing agency. “The first thing a millennial does is Google something,” Jonathan Catley, MD Connect’s sales and marketing director, said.

They have grown up with broadband, smartphones, laptops and social media being the norm and expect instant access to information, according to an online survey of 4,364 new college graduates by PricewaterhouseCoopers.[6]“The millennial generation’s world is digital and this has an inevitable effect on the way they communicate,” according to the report, “Millennials at work: Reshaping the Workplace.”[7]

That means communicating online or video conferencing rather than face-to-face or over the telephone. Email still has a place but “absolutely forget about faxes,” Denmark said. Instead, millennials expect[8] to be mobile, working with their smartphone from home, the office or cafes.

Millennials say[9] they routinely make use of apps running on their own smartphones, tablets and laptops while they are on the job. They often work outside of normal business hours, with about a fifth of them identifying as “night owls.” In other words, as the PricewaterhouseCoopers report put it, “millennials want a management style and corporate culture that is markedly different from anything that has gone before – one that meets their needs.”

Being a wired nomad may not as feasible for clinical trial workers as their peers in other industries because of concerns about compromising patient privacy by using insecure mobile technology. Indeed, encryption will be an issue that companies have to tackle as employees regardless of age and industry increasingly use their own devices filled by an array of apps.

TAMING THE PAPER STORM

Of course, changes are not easy, but John Silowsky, the clinical operations chief Bay Area-based Nektar Therapeutics, said the effort paid off when the company launched a Phase III program of a compound designed to treat chronic pain.

He knew he had a young staff that wouldn’t put up with the slow, top-down approach of most trials. So he decided the company was going to go in a new direction by “tearing down the walls” between Nektar and the vendors and sites involved in the program.  Silowsky brought in research sites and investigators early on, even before the protocol was developed “to make this journey” as a team.

“We were going rough and raw and putting out our work out there in the public space and making it available for review and comment,” he said. “It was scary.” But they tamed the paper storm and made the process more efficient and concise. It “took us to another level of collaboration,” Silowsky said. “We’re only a click away from our investigators our site staff and more importantly from our patients”.

By Tony Taricco, Co-Founder and COO at PRC Clinical

[1] http://xtalks.com/downloads/15q058.pdf

[2] http://xtalks.com/thankyou-15q058myclin.ashx

[3] http://xtalks.com/thankyou-15q058myclin.ashx

[4] http://www.pewresearch.org/fact-tank/2015/05/11/millennials-surpass-gen-xers-as-the-largest-generation-in-u-s-labor-force/

[5] http://www.mdconnectinc.com/about-md-connect/medical-marketing-insights/bid/77788/healthcare-marketing-and-the-millennials

[6] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[7] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[8] http://www.halogensoftware.com/blog/generation-y-understanding-the-work-habits-of-millennials

[9] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

16
Mar

Q&A Session: ClinCapture Builder Virtual Update on February 19th, 2015

We hosted our latest session of the ClinCapture Virtual Update on February 19th, 2015. Tom Hickerson, Clinovo’s Senior EDC Manager showcased ClinCapture’s self-service platform and drag-and-drop tools, and the latest enhancements added to ClinCapture Build Studio.

The attendees asked a number of questions on ClinCapture’s platform, Forms Studio (CRF designer), features, plans and more. See below a list of questions and answers that were asked during this session.

  • Do you offer online trainings?

Yes. You will see a number of different training options in the “Resources” tab of ClinCapture Builder. You can take advantage of the numerous video tutorials that will guide you through ClinCapture Builder, Forms Studio and Rules Studio. You can also enroll in complimentary ClinCapture eLearning composed of self-service on-demand modules with online quizzes, for five different roles, CRC, Study Monitor, Medical Coder, Study Administrator, and Investigator. In addition, you can also contact us via ClinCapture Builder for hands-on training for you and/or your team.

  • Is there an offline version of Forms Studio available for download?

There is no offline version of Forms Studio available.

  • Is it required to build studies manually? Can we use ODM.xml to build studies or is it possible to use an existing study to create a new one?

The first study will need to be built manually but we can assist you in cloning your studies once the first one has been created.

  • It is possible to publish a full study at once, or does each CRF need to be published separately?

We recommend that you follow the work flow and publish each CRF as it is completed but you are definitely able to start by creating your study, add your CRFs and publish the study once you have all the CRFs created.

  • Is the Forms Studio divider an aesthetic option or does it have an impact on the data structure/format?

The divider is an aesthetic option that allows you to break up your forms. You also have the option to break up your forms by adding another CRF page.

The upcoming session of our one-hour ClinCapture Virtual Update will be hosted on Friday, March 26th at 10am PST. Register for this virtual update at http://www.clinovo.com/virtual-update to see the latest enhancements to EDC system, ClinCapture.

For questions, please contact Molita Sorisho at Molita.Sorisho@clinovo.com.

22
Jan

Q&A Session from ClinCapture Builder Virtual Update on January 9th, 2015

We started the New Year at Clinovo by hosting the latest session of ClinCapture Builder Virtual Update on January 9th, 2015. During the live demo, our Senior EDC Manager Tom Hickerson showcased ClinCapture’s self-service platform and its do-it-yourself edit checks and case report form (CRF) build features recently added to ClinCapture, the only free validated Electronic Data Capture (EDC) system on the market.

The demo followed by a Q&A session to guide clinical trial professionals in their clinical study build efforts. A number of questions were asked by our participants on ClinCapture’s platform, Forms Studio (CRF designer), features and more. See below for a list of questions and answerers that were asked during our ClinCapture Builder Virtual Update on January 9, 2015

  • Is there a way to control which revision of a CRF a site is able to use? Yes. When visits are created in sites, there is an option available to hide all, one or specific numbers of CRF versions from a specific site. This feature is flexible and very easy to use.
  • How can ClinCapture be used for data collection in the medical device industry? ClinCapture is flexible enough that it can collect data taken either from a patient with a medical device during a doctor’s visit, or taken from a patient entering data by themselves with our ePRO solution. Clinovo currently has several medical device companies who actively use ClinCapture.
  • When extracting CRFs from the database, does the CRF version show in the header/footer of the pdf version of the CRF? Yes, the CRF Version number or name will be shown in printouts of the Subject Case Book or other printouts of the data.
  • Can you upload CRFs in Excel, or can they only be created in the form builder? Yes, once you have deployed a study using ClinCapture Builder, you are able to upload CRFs using Excel.  Furthermore, it’s worth pointing out that all the CRFs generate from Form Studio can be downloaded to excel from the CRF page as well.
  • Can you tell me how to make a local installation of Clinovo? As you may know, ClinCapture is open-source and you are welcome to download the ClinCapture application and install it on your system.  You can find out more information here: http://www.clinovo.com/downloads.  Please note however that your installation and system features will need to be validated, an estimated 15 man-month effort, before you can use it to collect and submit data to the FDA.  If you need a validated EDC system, you have the option to use ClinCapture for free or pay a low monthly hosting fee, depending on the features you need and your study size.
  • Can trial data be exported from the system?  If so, in what format(s)? ClinCapture is based on the CDISC ODM XML format, and as such can export your trial data in either that format, or Excel, Tab-separated values, SPSS or SAS.
  • Can we have multiple versions of the same form active in the production databases which are linked to a protocol version so depending upon IRB approval of the protocol can they see different CRFs? ClinCapture does allow different form versions to be active during study collection, and you can specify which of these form versions are visible for a specific site, so you have a great deal of control as to how many or how few versions you can have in your study at any one time.
  • How are partial dates stored? Our system allows you to enter the full date or month/date or the month/year or just a year.
  • Can you only archive one study from a group of studies? No our system will allows you to have more than one study in an instance with an option to archive one or all.
  • Is there a way to demo features in Premium/Ultra plans before switching? Most definitely. Our sales team will be able to demo features that are currently in Premium and Ultra plans.
  • Will all versions of the forms be included when is a study is archived? When archiving forms at the end, you will see a download bottom in your instance with all forms archived. The forms are also sent to you via email so you will always have access to all the forms that you designed.

The upcoming session of our one-hour ClinCapture Virtual Updates will be hosted on February 19th at 10am PST. Register for this Virtual Update at http://www.clinovo.com/virtual-update to see the latest enhancements to EDC system ClinCapture.

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

18
Nov

Internationalization and Localization of EDC: Tips, tricks and pitfalls

 

Tom Hickerson, Senior EDC Manager at ClinovoWe recently localized ClinCapture to Russian for Synergy Research Group, latest addition to our CRO partners, and thought I would share some of our best practices. We are honored that  ClinCapture is being presented by Synergy Research Group, in Moscow during the Clinical Trials Russia Conference taking place later this week. It’s always a real treat to work with a partner in the field, especially one that is working in an international space such as Russia, Central Asia, and Eastern Europe.

Tom Hickerson, Senior EDC Manager at Clinovo

Synergy is one of several partners that we’ve worked with this fall as part of our CRO Partnership Program, which gives us the opportunity to collaborate with CROs in the US and international fields. This is an exciting opportunity, as it allows us to collaborate with an entire ecosystem of global partners, and quickly take their feedback into account while we keep improving ClinCapture.

The challenge of Internationalization and Localization (often shortened to I18N and L10N because they are eighteen and ten letters from the first to the last letter) in an application is always a daunting task, especially in a project that has over ten years’ worth of development history. It’s worth pointing out that I18N refers to creating a system that has the potential of being translated to multiple languages, while L10N refers to the process of adapting a system to a specific language, which has already been internationalized. In our case, ClinCapture has been through multiple rounds of I18N, and the last round of L10N is taking place in Russian.

I’d like to write a little bit about how far we’ve come since the first internationalization project for ClinCapture. My first take-away to our readers: When you develop a feature, you need to assess from the start if this feature will need I18N/L10N, versus a feature to be used only in English, and implement with that requirement in mind as you work with the development roadmap.

I originally helped implement the first I18N changes in 2007 to OpenClinica, by implementing changes from an outside company called BAP Health in Spain. They were one of our first outside collaborators, and the I18N drive was completely driven by them as an open-source, community effort. It opened up the ability for us to apply our solutions to a number of European and Asian organizations and agencies, and was a great step forward in making the project more popular to its growing community.

Sharing the same open source code, ClinCapture has always been available in a number of languages since that time. However, we’ve grown quite a bit in the last two years, and the code and feature set for ClinCapture is much different now. There are certain challenges that you have to keep in mind as you grow an application and develop new multi-language features. They include the following:

  • Alphabets, and their encoding. ClinCapture has always captured data in a character encoding that allows for foreign alphabets, called Unicode. (For more on the subject and how this is a complex issue, you can read the landmark article by Joel Spolsky for developers here.) Now, you may get the impression that this is not really an issue, until you start to work with text files yourself. Editing files in Notepad, for example, will create one kind of encoding for your computer, while editing files in Microsoft Word will create something entirely different.
  • Dates. In working with dates, you quickly find out that Czech dates, French dates, Russian dates can all differ on the web page, but all have to be cleanly read and saved into the database in the same way. We’ve worked with many calendar widgets in the past, but are now upgrading the ‘date picker’ for all our dates to the latest standard in our upcoming releases. You can see more about the work we’re doing with that here.
  • Making sure your code is not affected by non-English characters. ‘Code’ exists at many levels, especially when we are talking about a rich web application like ClinCapture, which has Javascript running on the browser side and Java running on the server side. It’s especially important to review the Javascript and make sure that a word in Russian won’t accidentally break code, for example, where we were only expecting words in English.
  • Making sure settings are accurately reflected in the application. Up until now, ClinCapture kept track of its user’s language settings by looking at the browser setting. Our experience has been that sometimes, different browsers interpret the default language differently. Also, the language of the operating system may affect the browser’s language setting as well. To counter this unpredictability, ClinCapture will now ask for the user to define the language specifically. You can see more about the work we’re doing with that here.

The Developer Team and Testing Team are working very hard to make sure ClinCapture is the best not only in English, but in any language. There are always a number of issues with making sure any application is fully compliant and fully internationalized. Our engagement with partners and clients like Synergy Research gives us a short, positive feedback loop within which we can quickly find and fix issues with multiple language support.

What do you think about our technical feature set and roadmap for ClinCapture in the future? You are always welcome to sign up for a community account and contribute to the discussion here at our community development site. Also, if you are an international user or CRO and would like to see ClinCapture in your local language, you can contact us about collaborating with us in our next localization efforts.

Tom Hickerson, Senior EDC Manager at Clinovo
+ 1 800 987 6007
tom.hickerson@clinovo.com

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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27
Aug

Make the Switch to Electronic Data Capture (1/2)

Electronic Data Capture (EDC) collects clinical trial data electronically rather than on paper. It is becoming an increasingly popular solution for streamlining clinical data processing. Studies suggest that using EDC systems drastically reduces data errors and speeds up the overall trial process, therefore reducing clinical research costs by up to 20%. Clinical data quality is also dramatically improved when relying on EDC: According to the Regional Operations Manager at Eli Lilly in Canada, implementing an EDC system resulted in a 70 to 80% reduction in queries.

edc-adoption

 

However, the adoption of EDC (Electronic Data Capture) systems has remained slow in some segments of clinical research. According to Datamonitor, the market intelligence and data analysis firm, only 40% of Phase I clinical trials had adopted EDC by the end of 2011. 60% of Phase 2 clinical trials, 80% of Phase 3, 70% of Phase 4, and 5% of “Others” (non-FDA regulated studies) are utilizing EDC systems.

A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvements outweigh these difficulties. This paper aims at clarifying and facilitating the process of switching to Electronic Data Capture (EDC). We have listed below some of the essential points to consider before selecting and implementing an EDC system.

 1. Track Record

 The first thing to consider is the track record of the eClinical system vendor: How long have the vendor and its EDC system been on the market? On how many studies has the system been implemented? Can the vendor produce testimonials and case studies from past customers to substantiate its marketing claims? Was the system utilized for any FDA submissions?

2. Regulatory Compliance

Make sure the EDC system you’re evaluating is 21 CFR Part 11 Compliant. Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems. Also take EU regulations into consideration if you’re planning on running clinical trials in Europe.

  1. EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed.
  2. The EDC system provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database.
  3. The software employs electronic signatures for any transaction into the system.
  4. Vendors must also plan for disaster recovery and analyze and remedy potential risks.

We have found that some popular cost-efficient Electronic Data Capture (EDC) systems on the market are not 21 CFR Part 11 compliant, such as REDCap. These systems cannot be used for FDA-regulated clinical studies, but only for research and investigational purposes.

3. Data Security

Most EDC vendors offer a “secure hosting”, but we recommend to take a close look at where and how clinical data is being stored. Does the vendor provide disaster recovery? Is the data center SSAE-16 compliant? SSAE-16 (Statement on Standards for Attestation Engagements (SSAE) No. 16) defines the standards an auditor must employ in order to assess the contracted internal controls of a service organization, such as co-location service providers, including network and system management SOPs, security and business continuity.

4. Pricing model

The cost of implementing an EDC system can dramatically vary from a few thousand dollars to half a million dollars. Most EDC systems vendors charge customers a high upfront cost to cover heavy development and customization costs. The pricing model of most EDC systems is thus not transparent and varies depending on the project. Some systems will charge you depending on the number of users, which is well adapted to small clinical trials, but reportedly not scalable for longer and larger clinical trials.

Sophie McCallum

Director of Operations at Clinovo

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Make the Switch to EDC

Extract of Clinovo’s White Paper “Make the Switch to Electronic Data Capture”

Read the full White Paper on clinovo.com/papers

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21
Aug

Clinovo Published by Opensource.com – ‘Starting an Open Source Community For eClinical Systems’

Olivier Roth, Marketing Manager at Clinovo, recently interviewed with leading open source publication opensource.com on the company’s efforts in starting up an open source community around their Electronic Data Capture (EDC) system ClinCapture. In the interview, Mr Roth covers the benefits of community support around an open source platform, the company’s strategy for managing and growing the community, and both the pitfalls and successes they have experienced in the year since it was launched. 

“It was a bit of a support forum at the beginning” states Roth. “We’re now entering a new phase where several developers are investing their time and committing code. We also have representatives in other countries, including Israel and India, that are investing their time in providing useful feedback and code for new features.”

Mr Roth offers some simple advice for those looking to embark on a similar journey:

  • Be passionate about the open source model and your product
  • Make sure you plan properly
  • Provide an environment in which it’s easy to access and submit code
  • Engage your community

The full interview can be found here.

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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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