eClinicalOpinion

Electronic Data Capture Survey 2011

2011-10-26T10:39:00.000-04:00

Two years ago I completed my original EDC vendor survey and published it in an interactive form in the EDC Market explorer. It has been popular, with more than 2,000 unique visitors and 2,500 visits to date. I’ve had good feedback from those who have found it helpful when starting out with EDC vendor and system selection. Two years is a long time in the realm of Electronic Data Capture

What is Discworld ?

2010-11-04T18:54:00.001-04:00

In my post about Measurement Unit Conversions an Anonymous poster Andrew Chambers mentioned that his CDISC ODM Library tool, Discworld, had these conversions. You can read more about it at his blog. I have since had the opportunity to take a closer look at Discworld and its source code available at github Here’s a small code snippet: As you can see it’s coded in Lisp, one

EDC Survey: INFOTECH Soft Inc

2010-11-01T17:54:00.001-04:00

Company Information Website URL INFOTECH Soft Inc Founded Year 1998 CEO ? Company Type Private Address 1201 Brickell Ave, Suite 220, Miami, FL 33131 Country United States

Expert EDC Systems and Patient Templates

2010-09-09T16:09:00.001-04:00

In my last post on Expert Electronic Data Capture Systems I asked why I’m still writing BMI calculations in my EDC systems and I raised the idea of Patient Templates as a way of giving the EDC system a little more brains. I had some good feedback in the comments which have helped me think about this further so that I now think we need two levels of smarts built into the EDC system. 155

Expert Electronic Data Capture Systems

2010-09-06T08:43:00.001-04:00

One (incomplete) view of Electronic Data Capture is that it’s a way of building validation checks into your Case Report Forms. A paper form can’t tell you that you missed a question or that you’ve confused today’s date and the subjects date of birth but the validation checks built into the EDC system can. But when you look at the ways that those validation checks are programmed in EDC systems

Revisiting Patient Enrollment Visualization

2010-03-26T10:40:00.001-04:00

At the start of the year I posted a couple of entries on Visualizing Patient Enrollment and Simulating Patient Enrollment where I showed a video of a patient simulation and talked about my approach to generating the data. I enjoyed the challenge and thought it was interesting but I didn’t get any feedback and I moved on to other things. Then this month Roo commented on one of the posts

REDCap: EDC for Academic Research

2010-03-18T09:43:00.001-04:00

Project REDCap (REsearch Electronic Data Capture) is an EDC system that has been in development by the Vanderbilt Medical Center since 2004. According to the www.project-redcap.org site it is now in use in around 1,700 studies with nearly 6,000 end users. The development is supported by a $1.3M NIH grant and a consortium of around 100 institutions engaged in academic research. See their members

CDISC ODM MetaData as HTML - Update

2010-02-15T08:32:00.001-05:00

In my last post I described the use of the CDISC ODM XSL Stylesheet to display a CDISC ODM file in a HTML (web page) format. Jozef Aerts, one of the CDISC ODM volunteers and principal of XML4Pharma writes to say that he has since updated the stylesheet: ..including support for the new features (enhanced internationalization, new datatypes, conditional execution, SDTM and CDASH

Rendering CDISC ODM MetaData as HTML

2010-02-03T10:35:00.000-05:00

Back in July 2009 Jozef Aerts of XML4Pharma was kind enough to run the SAMP-101 example CDISC ODM MetaData file through his PDF Generator. The results can be seen in the SAMP-101 PDF. But PDF isn’t your only choice. If you are a member of the CDISC organization you also have access to the XSL stylesheet, crf,xsl, designed by David Iberson-Hurst of Assero Ltd and Anthony Friebel of SAS. This

2010 CDISC ODM Certifications

2010-02-02T11:01:00.001-05:00

At the end of April 2009 I wrote to complain about the lack of support for CDSIC from the EDC Vendor community at large. At that time only six of the 67 EDC vendors covered in the original EDC Survey had a CDISC certification. Recently I was prompted by Dirk Nelson of MedNet Solutions to revisit the CDISC list of ODM certified organizations because in November 2009 MedNet Solutions were

Simulating Patient Enrolment

2010-01-04T11:07:00.001-05:00

If you read my last post on Visualizing Patient Enrolment and watched the accompanying video you'll know all about my attempt to simulate and visualize patient enrollment in a clinical trial. To create the patient enrollment visualization I needed a stream of events - creation of country, site, patient and then state changes for the patients. These events drive the visualization prompting

Visualizing Patient Enrollment

2009-12-29T14:31:00.005-05:00

Any Electronic Data Capture system worth the name will give you a patient enrollment report of some kind. The good ones will provide a bar chart as well as an excel-like table of figures and an ability to drill-down from study to country to site level. That’s useful but it’s not very exciting. What if you could view patient enrollment like a video, watching at an accelerated timescale as

ODM Tutorial: Working with AdminData

2009-12-10T10:12:00.000-05:00

In the first ODM Tutorial I concentrated only on the study design MetaData elements of the ODM and didn't cover AdminData at all. What is AdminData? The ODM AdminData element is a container for information about Users and Locations (Study sites) that have involvement in the collection of the clinical data. In an ODM file AdminData appears inside the ODM element. You’ll see that

Using EDC at your clinical site? Take the time for a Survey

2009-09-30T10:16:00.001-04:00

TechTeam Global and the eClinical Forum are running a Survey to collect information about the use of EDC at clinical sites and how it has changed in the seven years since a survey of this type was last undertaken. If you are using EDC at your clinical site, help them out by answering the questions here: http://www.techteam.com/services/specialized-solution-support/

Oracle RDC Promotional Video

2009-07-15T09:08:00.000-04:00

Oracle seem to be promoting Oracle RDC more actively at the moment, not that you’d know it from the Oracle RDC marketing page. Those who dig further into their health sciences website will be rewarded with a link to a slickly produced video demo of Oracle RDC. Be warned. Rogue elements within Oracle marketing have deviated recklessly from the standard gray, red and black of the Oracle

SAMP-101 Jozef Aerts XML4Pharma Contribution

2009-07-09T09:33:00.000-04:00

Jozef Aerts of XML4Pharma has been very helpful in straightening out the errors and inconsistencies that appeared in early drafts of the ODM Tutorial and the SAMP-101 example ODM file. Last week my thoughts turned to visualizing ODM files and I mentioned the ODM PDF creation tool that Jozef offers at XML4Pharma. Jozef has kindly run the SAMP-101 ODM sample file (now version 1.2) through

Interview: Dominic Farmer, Cisiv CEO

2009-07-08T08:53:00.000-04:00

I’ve been throwing some emails back and forth with Dominic Farmer, CEO of Cisiv, to understand the company's position on real world patient data and EDC. Below is the email interview which came out of this correspondence, posted with Dominic’s permission. Eco: What are the origins of the cisiv platform? Baseline Plus developed from the requirements of a leading pharmaceutical company

Visualizing CDISC ODM Designs

2009-07-03T11:34:00.000-04:00

If you followed the ODM Tutorial you’ll remember the sample ODM file, SAMP101. One of the most underrated and under-explored features of doing study design with the ODM format is the ability to use XML-aware tools and programming languages to process an ODM file and do something with it. With some experience you can read an ODM file and get a feel for the contents but the native XML

DataSci Sues Medidata (again)

2009-06-28T18:24:00.001-04:00

Medidata had a great first day, their stock opened well above the $11-13 range that was first discussed and closed at $17, about 22% up. That’s the good news. The bad news is that Medidata’s success has not gone unnoticed by the more litigious elements of the eClinical market. On June 18th 2009 DataSci filed suit against Medidata in Maryland. Justia.com notes the nature of the

Medidata MDSO IPO is Live

2009-06-25T09:07:00.001-04:00

Ladies and Gentlemen, we have lift-off. Medidata is now listed on the NASDAQ with the stock ticker MDSO. Initial pricing $14 / share. More later… UPDATE: Medidata have had a great first day, their stock opened well above the $11-13 range that was first discussed and closed at $17, about 22% up. At one point the stock touched $19 before settling back to the $16 - $17 range. In all 5.5

OmniComm Systems buys eResearch EDC Unit

2009-06-25T08:36:00.000-04:00

What a week. DIA show is on, Medidata is about to float and now OmniComm Systems purchases the EDC Unit of ERT (formerly eResearch Technology) OmniComm are pretty serious about this acquisition issuing 8.1 Million shares of stock and opening a new New Jersey office for this new unit. ERT claims that the revenue for the EDC unit was nearly $6M in the year ending Dec 2008 and $1.4M in the

Medidata IPO Roadshow (34 Min video)

2009-06-15T10:25:00.001-04:00

I know you Medidata (soon to be MDSO) watchers will love this, the Medidata IPO roadshow video. Don’t you just love the internet? My notes…. Tarek Sherif (Chairman and CEO) says: …EDC a billion dollar addressable market… …under-served… …significant barriers to entry based on worldwide infrastructure needed… …40 – 50,000 trials running every year… .. 10,000 new clinical

Medidata to float June 17, days before DIA Show

2009-06-11T16:23:00.001-04:00

Coincidence or a deliberate move to steal all the buzz of this years Drug Information Association Annual Meeting in San Diego which starts on June 21? Probably the former but the timing of Medidata’s public offering and listing on the NASDAQ under the MDSO ticker symbol could not be much better for making a big splash at the DIA this year. According to this Reuters article:

DATATRAK delisted from the NASDAQ

2009-06-04T10:22:00.001-04:00

DATATRAK, a company with a very long history in the EDC market has been delisted from the NASDAQ exchange. The DATA ticker symbol is no longer valid and has been replaced by DATA.PK since DATATRAK shares are now being traded in the Pink-Sheets over-the-counter trading system. How did this happen? The straightforward answer is that, despite a slew of recent positive press releases, DATATRAK

Medidata reaches profitability: is IPO Near?

2009-06-03T17:41:00.001-04:00

Yesterday The Daily Startup Blog did a roundup of companies that had not withdrawn their IPO registrations and were still planning to launch after a 9 month period in which no company had tried to go public. The article, Analyzing The Remaining Venture-Backed IPO Candidates describes Medidata as “One of the best of the bunch from a financial standpoint.” and notes that “Medidata was able to