Trial Sponsors and Their Contract Labs: Better Collaboration via OpenClinica

At Geneuity Clinical Research Services, we do lab tests for trial sponsors. As readers of this blog know, we use OpenClinica internally as an LIS (laboratory information system), but as more and more drug companies and CRO’s adopt OpenClinica we foresee the day when we will be using their installations as our LIS, not ours.  A common platform will eliminate lots of duplicated effort and will allow for real-time transparency and better collaboration.  But it will also require sponsors to design their CRF’s with their contracting laboratories in mind.  In this article, we describe how this could be done.

First, consider specimen collection and tracking.  Normally, trial sponsors don’t consider doing this within the context of OpenClinica.  But they should.  Let’s say a specimen accidentally thaws in transit between the collection site and the contract lab.  Shouldn’t that fact be summarily recorded in the same context as the resulting lab test whose value may ultimately be reported to the FDA?  I should say so.

So, can OpenClinica be configured to do this? Yes and easily. A separate CRF dedicated to specimen collection could be designed and assigned to each event.  Alternatively, a specimen section could be added to already existing CRF’s.  Either way, fields for such things like accession number and specimen type could then be included.  These would be filled in by site personnel responsible for specimen collection.  Additional fields like ‘shipping deviations’ and ‘laboratory receipt date’ could also be included and would be filled in by lab personnel upon specimen delivery to the testing lab.  When it comes time for data analysis, the sponsor can use OpenClinica’s data export capabilities to exclude or include those lab results with shipping deviations and to investigate the consequences.

Other important aspects of specimen collection include printing labels to barcode samples and generating an attendant paper manifest (know as a requisition) against which labs can check incoming shipments of specimens.  OpenClinica can’t do such things currently.  It would require a whole new software module, but lots of added value could be achieved if one were written.  For instance, one can envision that after accessioning a specimen, site personnel could print a corresponding requisition from the same application window.  Also, imagine the time savings if lab personnel could conveniently print barcode labels after receiving a specimen and recording its receipt date and shipping deviations (if any).  And because the paper requisitions would be generated within the context of OpenClinica, subsequent source data verification by lab personnel could be expedited using QR-encoded URL’s that drill-down into the patient-event matrix. For more on this, see here.

Specimen tracking is just part of the story when it comes to sponsors and their contract labs.  Getting lab data from the laboratory testing platform into OpenClinica is another.  Recently during OpenClinica’s March 22 Global Conference in Bethesda, Akaza Research and Geneuity did a live demonstration of how this can be achieved using a set of MirthConnect channels. A batch of raw lab data keyed only to accession numbers was sent from Geneuity’s corporate headquarters in Maryville, TN to a remote OpenClinica installation hosted at Akaza’s Waltham, MA facility where it was inserted into the database programmatically via an awaiting web service. The insertion was streamlined, secure and seamless.  When setting up a trial, sponsors should think about the lessons this demo provides and consider distributing already configured and validated MirthConnect channels to their contract labs.  In this way, sponsors can control how their data is treated and understand every detail of its electronic provenance. And because MirthConnect can be configured to store its history, the trial’s audit trail can be extended upstream to the data’s very source.
Finally, consider invoicing.  Contract labs have to be paid when they do a test.  Monthly invoicing reports could be generated from OpenClinica by configuring an appropriate ‘data set’ and having it execute at the end of each month using the application’s new built-in quartz scheduler.  In this way, billing would be a snap and everybody would be on the same page.

In summary, how can trial sponsors configure OpenClinica to collaborate better with their contract labs? Do the following, keeping the workflow shown in Figure 1 in mind:

1.    Include a specimen accessioning CRF for each event.  Educate your collection-site people and your lab people as to who is responsible for which fields.  Use OpenClinica’s internal messaging system to remind people of their roles when the study is actually underway.
2.    Exploit OpenClinica’s web services framework to enable batch uploads of laboratory data.
3.    Configure and validate MirthConnect channels to get the lab results from the source data files to your OpenClinica installation.
4.    Distribute these channels to your lab contractors and educate them on their use.
5.    Configure OpenClinica to automatically generate monthly data sets for billing purposes.

The bottom-line: OpenClinica is infinitely configurable and sponsors should start doing so with their lab contractors in mind.  The result will mean both better collaboration and lower costs.

Figure 1: A specimen is collected from a subject on site. The on-site data manager logs into OpenClinica and accessions the sample and prints an accompanying hard-copy requisition. The sample is then shipped to the contracting laboratory where lab personnel log into OpenClinica and indicate they have received the sample. Specimens are then tested in batch and the results are then uploaded en masse into the sponsor's installation of OpenClinica using a thoroughly vetted, validated and auditable MirthConnect channeling system.

Preview of the March 22nd OpenClinica Global Conference

With just a week to go, the OpenClinica Global Conference is shaping up to be an excellent event for learning about OpenClinica and networking with members of the OpenClinica community.

This is the first ever Global Conference and we are thrilled to have as a keynote speaker Mark Adams, Project Manager for the National Cancer Institute’s Cancer Biomedical Informatics Grid (caBIG). As a fellow pioneer working to bring open source to clinical research domain, caBIG has developed a set of interoperable, open source clinical informatics tools which address functions such as adverse event reporting, patient registries, study calendaring, clinical trial management, imaging, and tissue banking. The caBIG project and OpenClinica together illustrate the broad impact open source is having on clinical trials.

The conference program extends along three tracks with case studies, panel discussions, tutorials, and presentations from clinical trial sponsors, CROs, academic groups, and IT services companies. Content is oriented towards both technical and non-technical audiences. Selected topics include:

  • An unveiling of the new OpenClinica CRF Library, a curated repository of standards-based eCRFs for OpenClinica
  • Case studies from sponsors and CROs showing how they have used OpenClinica
  • Presentations of tools and extensions developed around OpenClinica
  • Tutorial for installing OpenClinica
  • Tools, tips, and techniques for using OpenClinica data in SAS
  • Live demonstration of automated data interchange with OpenClinica
  • Automating the data import process
  • Validating OpenClinica for 21 CFR Part 11 compliance
  • Generating ad hoc reports
  • Modularization of the OpenClinica source code and introduction to the OpenClinica Developer Network

A full suite of training classes for data managers, biostatisticans, project managers, system administrators, and developers are also being offered immediately preceding and following the conference.

There is still time to register for this event. See www.openclinicaconference.org for more program information and registration details.

We look forward to seeing you next week!

OpenClinica 3.0.1 Features Improved CRF Save Times

Akaza Research will be releasing a maintenance update of OpenClinica 3.0, which by itself probably does not illicit much excitement.  Usually maintenance releases only fix small bugs and offer little noticeable improvements to a user’s overall experience.  However,  3.0.1 will offer a dramatic improvement for a user’s experience with regards to the amount of time it takes Rules to run on a CRF.

Users of previous versions of OpenClinica would reach pain points when trying to save data entered onto certain CRFs if the study build had applied very complex Rules on a particular CRF section. For example, if the system had to check more than 10 variables to ensure one particular field had accurate data, the user might experience a save time of 2 or even 3 minutes in some circumstances.  In a test environment, we were actually able to create a scenario where the CRF save time took 19 minutes!

As part of 3.0.1, among other things, we have dramatically improved the save time of a CRF with complex Rules.  For instance, in the extreme scenario utilized in our test environment, we were able to cut the save time from 19 minutes down to 10 seconds.  That is about a 11,400% improvement!  For more typical users who were experiencing 2 or 3 minute save times, this has been cut to 3-5 seconds.

We are committed to improving the performance of OpenClinica, and can even offer faster experiences to the users of the OpenClinica Enterprise Edition.  Please see our website for the differences between the Enterprise and Community versions of OpenClinica.

OpenClinica 3.0.1 will be out next week!

OpenClinica Community and Enterprise Editions

Dear OpenClinica Community,

We are only hours away now from the general release of OpenClinica 3.0. There is a ton of excitement here at Akaza as we get ready to see many months of hard work come to fruition.

In advance of this milestone I’d like to describe a few changes we’re making to how OpenClinica is organized and how the name and logo can be used.

A brief background: As a founding member of the OpenClinica® open source community, I constantly strive to ensure that our technology has a reputation for meeting the highest standards of quality. The growth of OpenClinica® over the past few years is a testament to some success in that area. In my role as CEO at Akaza Research, a business that has invested millions of dollars into development of this open source technology, I recognize that the same reputation of quality is critical to our ongoing success. Part of how we maintain this reputation is to provide quality control over solutions that bear the OpenClinica® name. To enable this, Akaza Research owns the registered trademarks for OpenClinica® and Akaza and reserves the rights to their use.

With the release of 3.0, we are publishing a trademark policy on our website (also summarized below) that defines how the OpenClinica® and Akaza Research® trademarks may be used by members of the OpenClinica community. Our goal is to protect the quality of the OpenClinica® and Akaza brands without inhibiting the freedom that comes with the open source software model. These trademark terms complement the flexibility of open source licensing, by clarifying and creating confidence in the quality and reliability of solutions that bear the OpenClinica® name.

The most visible way the policy will be manifested is by separating the Community and Enterprise editions of the software. The default software download from OpenClinica.org is the Community Edition, pre-configured in a way that complies with the requirements of the trademark policy. The policy itself covers allowed uses of the trademarks for commercial and non-commercial purposes, both for modified (derivative) works and for unmodified versions of the software.

Akaza’s OpenClinica Enterprise customers and partners will be granted separate licenses that include additional permissions on how they may use the trademark in their marketing, operations, and services activities. Their installations will be distinguished as “OpenClinica Enterprise Edition” via the label in the footer of their OpenClinica pages.

I want to stress that 100% of the core OpenClinica source code remains free and under an open source software license. It is our promise that this will always be the case. Over time Akaza will offer additional proprietary services and technology offerings as part of the OpenClinica Enterprise Edition to complement this core, but it is our goal to ensure that the Community Edition always stands on its own as a fully-functioning, 100% open source EDC/CDMS platform.

I hope you share my view that this new policy will provide the clarity and confidence that allow OpenClinica to continue to thrive, without imposing undue restrictions on members of the community.

With that (too lengthy) introduction, here is a summary of the policy. Click here for the detailed, legal version:

CategoryDescriptionTerms and Conditions
OpenClinica Community EditionYou download and install the software on your own, and are not commercially supported by Akaza.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.
OpenClinica Enterprise EditionYou are an OpenClinica Enterprise System Level Support subscribers. Other Akaza customers/partners and OpenClinica code contributors may meet the requirements of this category. Contact sales for more detail.Includes limited use of the OpenClinica brand for marketing and sales purposes, ongoing support, and display of “OpenClinica Enterprise Edition” in footer.
OpenClinica Community Edition – Derivative WorkYou download and install the software on your own, make modifications to the code, and are not commercially supported by Akaza. You want to keep the OpenClinica name/logo in the modified version.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.. You must also clearly state the software has been modified and the modifications are not supported by Akaza.
Other Derivative WorksYou choose to strip out the references to the OpenClinica and Akaza names and logos from your modified version of the software. The trademark policy does not apply.The OpenClinica source code is licensed under the GNU Lesser General Public License (LGPL). You still must follow the terms of the LGPL, including copyright attribution and requirements for redistribution of source code. Of course, if you choose to follow this course, we hope you’ll also let us know about your software modifications and will contribute these back to the core repositories, both for the benefit of the community and to help ensuring future compatibility of your flavor of the software.

If you are a community user of a prior version of OpenClinica and do not intend to upgrade to the latest release, please contact us if you have questions about how the new policy may affect you.

Best Regards,

Cal Collins

CEO, Akaza Research

OpenClinica 3.0 Completes Functional Testing; Enters Deployment Testing

OpenClinica 3.0 is almost here! The quality team has successfully completed functional testing and has moved onto the phase of software quality assurance called deployment testing.  Deployment tests cover 8 different target “platforms” that range from a clean installation of OpenClinica 3.0 on a Windows server using Postgres, to upgrades of OpenClinica 2.5 to 3.0 on a Linux machine using an Oracle Database. Of course, we also test on all combinations in between.

Before the production version of the application can be released, it must successfully pass through our Quality System. For those of you familiar with such a thing, all of the testing and documentation that OpenClinica 3.0 is going through will end up generating thousands of pages of “paper” that include user requirements, traceability matrix, and a large set of screenshots which prove the expected results of the test cases did in fact happen.

In addition to the team at Akaza that has invested thousands of hours testing the application, this release has also undergone road testing in our first OpenClinica Pilot Program.  I would like to warmly thank the participants of the program for committing their time and effort in making sure OpenClinica 3.0 is our most well vetted release to date.

Please look for an announcement from me in the coming days of when OpenClinica 3.0 is available for download.

– Paul Galvin, Project Manager

OpenClinica and the Paper Chase: A Case Study

The developers of OpenClinica like to say they are ‘powering the electronic data capture (EDC) revolution’ in clinical data management and indeed that’s the case.  However, sometimes there’s no substitute for paper, especially when it comes to tracking and handling laboratory specimens.  We at Geneuity should know: testing lab specimens for clinical trials is our business.  This article shows how OpenClinica and paper records can augment one another through the use of URL-encoding barcodes.

Readers of this blog probably already know the drill:  a specimen is collected, a paper requisition is attached and the whole kit and kaboodle is mailed to a laboratory for testing.  When a specimen arrives at Geneuity, we log into OpenClinica’s web interface, look up the patient and event pairing in the subject matrix as specified by the requisition and then finally type in the values for items like accession number, receipt date, shipping deviations, freezer location and the like.  When one or two specimens arrive, this process (called ‘accessioning’) is no problem; when 20 to 60 arrive, it rapidly becomes tedious.

In a more perfect world, things would be easier and more automated.  Here’s one potential scenario to help achieve this.  In addition to all the necessary information in human-readable form, also print on the requisition a QR barcode that encodes the URL corresponding to the appropriate event case report form (CRF) in the study’s OpenClinica installation.  For instance, consider the example shown in Figure 1.

It encodes: “https://myOpenClinicaInstall.com/InitialDataEntry?eventCRFId=1” (for illustration only, not intended to link anywhere for real).  Upon being scanned with an appropriate hand-held reader (or smart-phone even), this would automatically direct the lab technician’s browser to the correct screen to input the attendant accessioning information for study event number one.  This would eliminate the manual look-up step described above and would reduce tedium and errors as a consequence.

Implementing this idea would require enabling OpenClinica to print out requisitions.  While challenging, this would not be impossible.  Indeed, middle-ware like MirthConnect may make it relatively easy.

Here’s another example of paper and OpenClinica working together, one that Geneuity actually implements currently to facilitate quality control.  Prior to testing a batch of specimens, lab technicians here use a custom Mirth channel to print out details of the samples to be tested.  A dummy example is shown in Figure 2.  As shown, it includes a simple linear barcode of the accession number, the principle means of tracking specimens in a clinical lab.  Scanning this saves the technician from having to type it into the testing platform during set-up.  It also contains a QR barcode specifying the event-specific URL that directs the technician where to go to review the data upon automatic upload into OpenClinica.  Having this URL handy means the technician doesn’t have to look it up in the subject matrix table which oftentimes has hundreds or even thousands of entries.

URL-encoding barcodes are a cheap and reliable way of linking physical objects with on-line databases, and nowhere is this link more critical than when tracking clinical specimens.  Thanks to Akaza’s commitment to open source, it’s easy to incorporate this technology into OpenClinica and to realize the myriad of benefits.

Figure 1: a QR barcode encoding an event-specific URL in a mock OpenClinica installation
Figure 1: a QR barcode encoding an event-specific URL in a mock OpenClinica installation
Figure 2: A list of specimens to be tested reported by a Mirth channel extracting from a mock OpenClinica installation.  The linear barcode helps with data entry at the testing platform while the 2D QR barcode is used to direct the lab tech's browser to the appropriate URL in OpenClinica for subsequent data review after testing is complete.
Figure 2: A list of specimens to be tested reported by a Mirth channel extracting from a mock OpenClinica installation. The linear barcode helps with data entry at the testing platform while the 2D QR barcode is used to direct the lab tech's browser to the appropriate URL in OpenClinica for subsequent data review after testing is complete.

Selling open source without mentioning open source

I am a regular reader of  “The Open Road” blog by Matt Assay on news.com. In one of his latest posts, “Getting open-source criticism wrong”, he does a great job of making the case that commercial open source software is about ease of adoption, flexibility, and choice.

It struck a chord because my sales team and I spend a great amount of time and effort explaining to prospective customers that we offer the same level of quality, stability, performance, service, and support as a proprietary vendor. In many cases we must meet a higher threshold than those vendors, because we do not have the lock-in of a commercial software license to compel customers to come back to us for repeat business. Our track record of successful long-term customer relationship is evidence we meet this threshold.

In certain sales situations, for the sake of simplicity and clarity, we have to focus only on these apples-to-apples characteristics, and do not have the opportunity to educate on the economic and technical advantages of OSS as much as we would like. It’s great to know that our open source clinical data management software technology and service offerings can stand successfully on these merits. However, as many readers of this blog already know, open source offers an additional set of critical benefits: “the ability to adopt software rapidly and at low cost, the flexibility to develop and extend their systems as they choose, and the ability to reduce risk by obtaining paid commercial-grade [or better] support”. As more decision makers are coming to understand, it is following this path, rather than the adoption of pricey, monolithic proprietary software, that leads to better outcomes and greater ROI.

An Opportunity for Transformational Change in Clinical Trials

Life sciences research is recognized as one of the most technologically advanced, groundbreaking endeavors of modern times. Nevertheless until very recently the preferred technology for executing the most critical, costly stage of the R&D process – clinical trials – has been paper forms. Only in 2008 did adoption of electronic alternatives to paper forms take place in more than half of new trials. This recent uptick in adoption rates is encouraging, but further transformational change in the industry is necessary to fully realize the promise of Electronic Data Capture (EDC) and associated “eClinical” technologies. Two developments that could provide the framework for such change are adoption of open data standards and the use of Open Source Software.

Data standards provide uniform ways to represent information or processes within a specific frame of reference and according to a detailed specification. A standard is “open” when it is not encumbered by patent, cost, or usage restrictions. Open Source Software (OSS) is defined loosely as software that allows programmers to openly read, redistribute, and modify the source code of that software. The combination of OSS and open standards is a proven way to deliver improved flexibility, quality, and efficiency.

A community-driven open source offering that harnesses open standards can produce robust, innovative technology solutions for use in regulated clinical trial environments. Most Open Source Software is built using a collaborative development model. The OSS development and licensing model encourages experimentation, reduces ‘reinvention of the wheel’, and allows otherwise unaffiliated parties to build on the work of others. The result is that OSS can become a key driver of increased IT efficiency and a way to wring out unnecessary costs. In many cases, users can have the best of all worlds: the ability to adopt software rapidly and at low cost, the flexibility to develop and extend their systems as they choose, and the ability to reduce risk by obtaining paid commercial-grade support.

As clinical research struggles to become more automated and efficient, we need to rely on interoperable systems to meet challenges of flexibility, quality, and speed. The OSS development model also naturally leads to the adoption of well-documented, open standards. Because OSS product designers and developers tend to reuse successful components and models where available, OSS technologies are often leading implementers of standards. For example, the National Cancer Institute’s Cancer Bioinformatics Grid (caBIG) initiative is “designed to further medicine’s potential through an open source network” based on open data standards and infrastructure that support sharing of heterogeneous data. This remarkable effort aims to connect large networks of researchers in ways that enables efficient re-use of data, eliminates duplicate systems, and enables new types of translational research.

In industry-sponsored clinical trials, standards such as the CDISC Operational Data Model (ODM), Clinical Data Acquisition Standards Harmonization (CDASH), and Study Data Tabulation Model (SDTM) have gained adoption in both proprietary and OSS software platforms. In some cases, standards are mandated for regulatory submission and reporting (SDTM, clinicaltrials.gov) and obviously must be adopted. Other cases, such as use of ODM, CDASH, and general web standards such as web services and XForms tend to be adopted to the degree they have a compelling business case.

The business case for standards centers on increasing accuracy and repeatability, enabling reuse of data, and enhancing efficiency by use of a common toolset. A well-designed standard does not inhibit flexibility, but presupposes idiosyncrasies and allows extension to support ‘corner cases’. Leading industry voices share compelling arguments how to use standards such as ODM, CDASH, XForms, and Web Services to achieve these goals. Though the details are complicated, the approach offers orchestration of disparate applications and organization of metadata across multiple systems. There is change control support and a single ‘source of truth’ for each data point or study configuration parameter, so when study designs change (as they inevitably do) or a previously committed data point is rolled back, it is automatically shared and manual updates to systems are not necessary. Because the ODM, CDASH, and SDTM are used as a common “language”, the systems know the meaning and structure of data and can process transactions accordingly. Here’s a tangible example:

Lets imagine an IVR system wanted to check with an EDC system if a subject was current in a study (current meaning not dropped out, early terminated or a screen failure).  A Web Service could be offered by the EDC system to respond with a ‘True’ or ‘False’ to a call ‘IS_SUBJECT_CURRENT’ ?  Of course hand-shaking would need to occur before it hand [sic] for security and so on, but following this, the IVR system would simply need to make the call, provide a unique Subject identifier, and the EDC system web service would respond with either ‘True’ or ‘False.  With Web Services, this can potentially occur in less than a second.

Electronic Data Capture – Technology Blog, September 28, 2008

While this integration requirement could be satisfied by development of point-to-point, proprietary interfaces, this approach is brittle, costly, and does not scale well to support a third or fourth-party system participating in the transaction. It is critical that standards be open so that parties can adopt and implement them independently, and later interface their systems together when the business case calls for it. A leading industry blogger makes the case for the openness of standards within the ODM’s ‘Vendor Extension’ architecture: ”The ODM is an open standard, the spec is available for free and anyone can implement it. This encourages innovation and lowers the barriers to entry and therefore costs. Vendor Extensions are not open, the vendor is under no obligation to share them with the market and the effect is that meta-tools and inter-operability are held back.”

Having the software that implements these standards released as open source code only strengthens its benefits. Proprietary software can implement open standards, however given the proprietary vendor’s business interest to lock-in license revenue, might the vendor be tempted into tweaking or ‘extending’ the standard in a way that is encumbered to lock users into their platform? This strategy of “embrace, extend, extinguish” was made famous in the Microsoft anti-trust case of the 1990s, where it came to light that the company attempted to apply these principles to key Internet networking protocols, HTML and web browser standards, and the Java programming language. They hoped to marginalize competing platforms that did not support their “extended” versions of the standards. Thankfully, they had limited success in this effort, and the Internet has flourished into the open, constantly innovating, non-proprietary network that we know today. The eClinical technology field is at a similar crossroads. By embracing open standards, and working concertedly to provide business value in re-usable OSS technology, we can achieve a transformation in the productivity of our clinical technology investments.

OpenClinica 3.0 Features Preview – Part II

Welcome to Part II of the OpenClinica 3.0 features! I previously wrote about three of the main features for 3.0, Source Data Verification, new User Interface for navigation in the system, and a new Home Page for each user.

This post is about three additional features: (i) the new Build Study module, (ii) setting the length and significant digits of items, and (iii) the improved performance of the Subject Matrix.

In 3.0,  all the study build tools will accessed from one main page following a task-based approach. There are five tasks available to the user at the outset. Once the user finishes these first five tasks, two more tasks will become available (see image). This allows the complete study from CRFs to event definitions to sites to assignment of users be done all from a single page. There is also a checklist to let the user easily see how many tasks have been completed so they know how much more configuration is needed before the study is ready to start enrolling subjects.

Build Study Page in OpenClinica

OpenClinica 3.0 also allows the creator of CRFs to set the allowable length of  text fields including the number of decimal places a REAL number should be rounded to. This parameter is set in the OpenClinica CRF Template in a new field called Width_Decimal. The user will specify the width and decimal for a particular field which will force the user to enter the most precise data as possible in a CRF. No longer will the system round to the 4th decimal place at all times and allow up to 255 characters in the field if the CRF creator does not want them to. For example, the creator could specify that a field should have no more than 5 digits total with a maximum of 1 decimal place by entering 5(1) in the Width_Decimal column of the OpenClinica template. If the data entry person tried to enter 3.4444 or 678913 they would told the value is invalid.

By providing this functionality, OpenClinica will help the users get their data into SAS and SPSS more easily.

One of the most important and information-rich pages in OpenClinica is Subject Matrix page, and OpenClinica 3.0 provides significant performance enhancements on this page for studies with large numbers of of subjects.  From the Subject Matrix page users can see a snapshot of where the subjects are in the study, schedule a new event, view a subject record, view a subject event, enter data in a CRF and sign a subject’s record without having to navigate to different pages in this system. A number of users were reporting sluggish performance with the Subject Matrix when they had 5000 or more subjects enrolled in a study.

OpenClinica 3.0 utilizes a new table structure that allows users to load the Subject Matrix containing over 10,000 subjects and 15 event definitions in fewer than 5 seconds (this process could take upwards of a minute in previous releases of OpenClinica).

Please feel free to download the Beta version of OpenClinica 3.0 at http://svn.akazaresearch.com/OpenClinica-3.0-distros/.

OpenClinica and Open Source at DIA Annual Meeting

Akaza Research is pleased to announce that Cal Collins will deliver a presentation at the Drug Information Association’s (DIA’s) 45th Annual Meeting, June 21-25, in San Diego, CA. The session, titled “Utilizing and Integrating Open Source Software in Clinical Research Environments,” will explore how open source, standards-based software can improve flexibility, interoperability, and cost in clinical trials. It will take place June 22, 10:30AM – 12:00PM (Pacific Standard Time) in Room 15B.

At the event Akaza Research will also be exhibiting OpenClinica, its flagship open source clinical trials software product for electronic data capture (EDC) and clinical data management. Personnel from Akaza Research will be on-hand to demonstrate OpenClinica and answer questions.