Tag Archives: eClinical

Case Study 3: Out-of-Box Solution

The Scenario:

The Sponsor required a solution to effectively manage and control users (internal and external).
RA eClinica Solution:

    • RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
    • Develop, deploy and host the clinical documentation service and provide customer support.

Ra eClinica Results:

    • Development of an electronic tool to manage the program and provide ongoing operational management support..
    • Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
    • Reports are XML-tagged for further integration with in-house systems and third party service providers,
    • Integrated Help desk support system

Anayansi gamboa - Out of the box solutions by RA eClinica

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

 

 
The Scenario:

The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Case Study 1: Stand Alone Satellite Office Solution

Integrated Into Sponsor’s Clinical Data Management (CDM) Environment

Anayansi gamboa - offshore Panama Data management

 

 

 

 

The Scenario:

The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor’s CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resources on-site was not an option.

RA eClinica Solution:

  • RA eClinica Data Management Operations collaborated with Sponsor to develop CDM metrics, collaboration model and workflow, enabling the team to work across 3+ protocols
  • RA eClinica provided a full solution of 5+ CDM resources, project management, dedicated secure facilities integrating into Sponsor’s eClinical and CDMS databases.

Ra eClinica Results:

  • Develop of a long-term, efficient and cost-effective CDM solution.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica – Open Source and Oracle Clinical.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Source:

SAS Institute
CDISC

For Once, in the Right Place at the Right Time?

Dutch Windmills
Learning a Language – Courtesy of Babbel

One of the hardest obstacles I have had to overcome since actually ‘levende’ here as opposed to having a ‘vakantiehuis’ is having a broaden my use of Dutch. Let’s face it, the vocabulary used for shopping, restaurants, the weather and other public places isn’t much use when trying to sort out business professionals, government officials and the like. Your neighbours also expect a little more variety of conversation than ‘goedemorgen, dag, tot ziens’ when they are seeing you on a regular basis.
Learning is a very personal thing dependent on what suits you best and what kind of learner you are. Let’s just say that my memory is not what it used to be!

As far as how these experiences applied to the clinical work or projects, you need to have certain things in place:

  • Discipline and deadlines. Do not confuse this with ‘time management’. I am sort of a person who works better under pressure. Consistency is key to language learning. You can make progress in any language or technology with just a few minutes a day.

Time Management is an illusion. Time cannot be managed. All we are able to manage are activities. Bob Proctor

    • Revision. Being able to speak multiple languages in Europe is common. Most Europeans citizens speak on average two (2) languages some even three or four. Even though I can speak three (3) languages with ease, I really need so much learning with the Dutch. It is not use assuming that I have mastered one verb and then moving onto the next because I won’t have. Same, when you learn a new EDC tool,  you need to practice and revisit all what you have learned. As they say, practice makes perfect!
Map of Europe - Blank Map (summer style)
EU Map – AVG Languages Spoken
  • Writing things down. I am a visual/show me first kind of learner so I take in information better once I have written it down and even better if I use my mind to map and draw it. So find what suits you best to improve your EDC learning experiences.
  • Speaking. I need to use the new material immediately for it to go into my memory. Learn to speak the EDC programming language.
  • Reading. This will improve your vocabulary and help you with the grammar and spelling. Spend time reading online blogs, biotechnology magazines, youtube technology channels and even your own company’s WPs / SOPs as they will help you be a better EDC developer.

The knowledge that my horizons can be so much wider than I thought, that you can communicate and connect with people and make a home in a different place. I have come to embody a very different mentality. Being here has given me many opportunities, but one of the biggest changes has been having the time and money to travel, and of course, learn to speak a new language.

I hope this helps. I have found some useful resources and they are listed all over this blog. In the future, I plan to add more resources and training materials. Remember that learning and development are lifetime activities—there’s no finish line.

Amazingly, I think I can be sure for once I was in the right place at the right time.

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

OpenClinica: Printing subject casebooks, blank casebooks and blank CRFs

Wanna print subject casebooks using OpenClinica? This article is an extract from a video demo from the OpenClinica blog website. Click the link below now.

Source: http://blog.openclinica.com/2014/10/06/video-demos-printing-subject-casebooks-blank-casebooks-and-blank-crfs/

Happy Printing!!!

 

Fair Use Notice: This video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

4 Programming Languages You Should Learn Right Now (eClinical Speaking)

I am a strong believer that learning a new language makes you better at the others, but I am not a “learn to code” advocate since a foreign language (I know 3 languages and currently learning my 4th and I have a “to learn” language including Italian and Arabic, if I ever find some free time) or even music (I love to play drums) are equally beneficial. But if you want to obtain a job in the pharmaceutical industry, here are the list of programming languages you should learn:

  1. C#:

What it is: A general-purpose, compiled, object-oriented programming language developed by Microsoft as part of its .NET initiative.

Why you should learn it: If you are looking to become a Medidata Custom Function programmer or Oracle InForm EDC Developer then you should.

2. Python:

What it is: An interpreted, dynamically object-oriented, open-source programming language that utilizes automatic memory management.

Why you should learn it: If you are like me always looking to learn new technology, love Google platforms and perhaps want to become a Timaeus Trial Builder, you should learn it. It is used on a lot open-source technologies.

Everyone should learn to code

3. PL/SQL or SQL:

What it is: PL/SQL stands for Procedural Language/SQL.

Why you should learn it: If you are like me additive to databases then Oracle should be your choice. If you want to become an Oracle Clinical programmer or Database administrator, you should learn Oracle PL/SQL.

4- SAS

What it is: SAS stands for “Statistical Analysis System” (software). It is the most powerful and comprehensive statistics software available.

Why you should learn it: SAS skills are in high demand nowadays. If you are able to obtain the SAS Certification and a few years of experience in the Pharmaceutical industry, you will be in good shape. If you are new and looking for training there are several options available from SAS Institute to private vendors such as Clinovo to even learning on your own. I most warn you as it will be difficult to obtain a job without experience. Nevertheless, once you are in, it can only get better.

Remember that your job is not just to code but to solve real problems. Your ability to code covers a lot of range of skills: from critical thinking, problem analysis & solving, logic, etc.

So which one are you going to give a try?

Let me know what is your preference. Happy Programming!

The best thing about a boolean is even if you are wrong, you are only off by a bit.(Anonymous)

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Source:
SAS Institute
Learn PL/SQL

Central Designer – Troubleshooting Tips

If an edit check or function fails to behave as expected, it is time to use your ‘troubleshooting’ skills. The following tips may help you when you are troubleshooting rules in InForm:

Rules:

  • check if rules are running
  • check the rule logic
  • check Rule Dependencies: a rule on a form has access to items on that form, but not other forms or other visits
  • check InForm machine’s Application Event Log

Though some vendors will correct major problems with their products by releasing entirely new versions, other vendors may fix minor bugs by issuing patches, small software updates that address problems detected by users or developers.

Check the release notes for Central Designer for known problems. The release notes provide descriptions and workaround solutions for known problems.
Remember that there is a report available you can run “Data Entry Rule Actions Report”. This report outputs all data entry rules in CSV format and can be formatted into an edit check specification documentation for QA testing.
A rule can be written in more than one way, which makes it difficult to impose any restrictions:
Scenario: Route item has 3 choices. OP, SC and IV. Query should fire if the user does not choose either OP or SC. This rule could be written in many ways:

–Value = route.Value

If (value == 3)

–Value = route.Value == 3

If (value == true)

–Value = !(route.Value == 3)

If (value == false)

–Value = (route.Value == 1 || route.Value == 2)

If (value == false)

–Value = route.Value !=1 && route.Value != 2

If (value == true)

Keep it consistent across the trial. Do not overuse the conditional statements when a simple range check should be program.

Note: Be aware that if you want to reuse a rule that uses data from a logical schema in another study, the other study must also contain the logical schema.

If you have explored most of the obvious possibilities and still
cannot get your rule / edit check to work, ask someone in your team to peer review the build.

 

  • unit test your code
  • context available for defining test cases
  • Site name, date/time, locale; Form associations; Empty values; Unknown dates; Repeating objects
  • test case results: Pass or Fail based on expected results
  • perform formal QA / QT

Remember to check the Event log via Control Panel -> Administrative Tools -> Event Viewer

Reference Document : Central Designer – Rule Troubleshooting.pdf

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

SAS Programmers Tools

Are you new to SAS and wondering how to write SAS programs?

Most SAS programmers use the built-in SAS enhanced editor for their daily works. Sometimes, this editor is replaced by the code editor of SAS Enterprise Guide which provide other features like the Log tab, Output data tab and Results tab. However, some SAS users like their text editor to be very customizable and full of features which may or may not be in the enhanced editor.

If you find that your current editor is insufficient in handling your work you are not alone. We have found some alternative editors and below are some of the text editors I have come across that you can use instead of the pre-built SAS editor:

TextPad: is a full-featured text editor offering a spelling checker, macros, and powerful formatting and file-storage options from Helios Software Solutions.

This is a great program – it’s a powerful text editing tool that’s really comfortable to use. Textpad has a very clean, simple interface that deals only with text – that is, it doesn’t let you change font halfway down the page, or make text underlined or italic; it’s built purely to deal with the content, and does that job EXTREMELY well.

These features are excellent for SAS macro programming and SCL programming. Besides these, Textpad has a built-in compiler for Java which allows for rapid switching to Java coding that is occasionally required.

Below is a screen shot of the editor:

Textpad has many macro features that allows for repetitive actions to be recorded and recycled easily.

Crimson Editor is a professional source editor for Windows Open source from Ingyu Kang and one of the most popular editor available for programmers to use.

This editor also allow programmers to install schematics (define tools) that will highlight sections of your SAS programs.

Below is a screen shot of the editor:

In summary, there are many options to help a SAS programmer increase efficiency, write cleaner code, or make SAS life easier. There are other popular editors such as Emacs but I don’t have a lot of experience using it thus I cannot comment on it properly. Your style of programming will influence the type of editor you will use.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

What is Clinical Reviewer?

Clinical Review on iPad

  1. CRF Images View CRF (Case Report Form) data with pinch zoom.
  2. SAS Datasets Search and view data exported from SAS datasets.
  3. DEFINE.XML Import meta data directly from DEFINE.XML.
  4. Control Terminology View all metadata including coded terms defined in DEFINE.XML
  5. Secure Data – Data transferred to local memory viewed in “Airplane” mode with self deleting expiration.

Clinical data can be imported from standard CDISC DEFINE.XML format directly onto Clinical Reviewer app on iPad. Take advantage of the multi-touch interface to view Case Report Form or SAS datasets directly. Metadata including variable and value level metadata is viewable as defined in DEFINE.XML.

Watch this tutorial and see for yourself…

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Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.