Tag Archives: Clinical data management training

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.

Castor EDC – Data Management Made Easy!

I recently was approached by a group of scientists that have developed a unique EDC system for researchers. Usually, you have a group of developers or gurus / geeks around some science major staff trying to understand how the EDC system they purchased works. But to hear that the system was actually developed by the scientists itself was news to me. So the email piqued my curiosity.  And as the email stated ‘our goal is make professional data management systems available for every researcher,’ I proceeded to spend time researching more.

As per my previous post, I like to ask the question about ‘names’ so here I asked the founder of Castor the same question…What is in the name besides letters? 

Castor is the Latin name for the beaver family, and the logo is designed as a safe haven (the wall around the dot) for data (the dot in the center), but still accessible, just like a beaver’s ‘lodge’: hard to get into, but safe and comfortable inside.-Derk, founder

Why Castor?

Affordable multicenter EDC, GCP compliance, that is self-managed and you can do everything yourself. The system works on any platform and everybody can use it.

How to get started?

There are NO contracts or third-party involvement. You go to CastorEDC portal and click on –> Register

Anayansi Gamboa - Castor EDC

Create a new Study – once you have registered, you start building your study with ‘form builder’ tool. In order to build a form, you need to create phases (called usually visits like screening, visit 1, visit 2 and so on) and forms (that are referred by Castor EDC as ‘steps’ such as ‘Inclusion / Exclusion Criterias, Demographics, Vital Signs’, etc).

Now that you have defined your visits and forms, you need to add your fields. To the left of the form builder, you will find pre-defined set of fields from yes/no radio buttons to text fields to date fields and checkboxes. There are a lot of field types with several properties for each fields.

Another good feature is called ‘dependencies’.  For example, if you have a RACE field that collects multiple races codes including the OTHER, specify option; you can have a dependency text field appears ONLY when the OTHER option is checked.

Castor EDC Demo Castor EDC - Demo

Is Castor EDC CDISC-Compliant?

Currently, the system is being upgraded to comply with CDISC standards and this feature should be available by end of 2015.

Is castor EDC Affordable?

To calculate your own price or to have an idea of how much it will cost you to run your trial or research project, go to Pricing and Features.

Why people are choosing Castor EDC?

Reason 1 – It is fast –  your trial is up and running in days.
Reason 2 – Affordable – packages to fit any budget. No more Access or Excel to collect data.
Reason 3  – Easy to Use – Everyone can enter data with Castor EDC

Using Castor EDC is very easy, just follow these 10 steps:
1. Create your account.
2. Create your Study.
3. Build your Study structure.
4. Build forms for study data, reports for repeated data (i.e. SAE forms) and surveys for patient questionnaires (ePRO’s).
5. Test your forms via record management.
6. Check your settings , set randomization, record ID generation, and multicenter options.
7. Invite colleagues and participating researchers.
8. Set rights for every individual user.
9. Set your Study to live to start collecting real data.
10. Collect clean and valid data for your study!

Need more information?

See castoredc.com if you need affordable Electronic Data Collection for your study.

If you are looking for a study builder or clinical programmer to support your clinical trials and data management department, please use the contact form.

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

 

Data verification puzzles

 

Important part of the data management job is to verify received data. Checking for inconsistencies and unexpected patterns. Verifying that the data is complete, legible, logical and plausible.

However, how to perform data verification?

You could regard the data verification job as completing a couple of puzzles. Each puzzle is one subject participating in the clinical trial or clinical study at stake. As such, the puzzles resemble each other a great deal. But they are not exact copies. Each subject, each puzzle, is (slightly) different, unique.

Pleasant and thoughtful team action:

Do you have a puzzle somewhere in a cupboard? More than one from the same series? At least 2 puzzles with > 100 pieces each? Open the boxes, drop their content in one pile on the table and start completing the puzzles/subjects. The more pieces in place of a puzzle, the more evident which pieces to expect.

1. Get the parts received, divide them per subject/puzzle and start making all the puzzles. The clinical information up on each subject is coming in pieces, per completed visit data, per available adverse event information. In the beginning you’ll thus work with lots of incomplete puzzles.

2. Any holes in any puzzle/subject, any missing parts, you need to look for/query. Note that holes are allowed if your puzzle/story is as such! However, leave no unexpected holes. Meaning that if an assessment took place, you want to have the corresponding result(s) completed.

3. Any duplicate pieces, get rid of them. Please query.

4. Any pieces not fitting your puzzle/subject story, you need to check up on. Maybe they belong to another puzzle/subject. Or they are incomplete and can therefore not fit (yet). They could even be wrong delivered and not belong to the study at all.

5. Any pieces fitting but rotated 90 or 180 degrees, please turn/query. Get the puzzle showing a logical story.

6. Any pieces damaged, please try to fix the damaged parts. E.g. spilled coffee over a paper CRF. Illegible text parts. Or unclear texts that can be interpreted differently.

7. Any pieces added at the wrong place, query and bring to their right position. E.g. an error in an assessment date.

In trial/study language, the more data for a subject received and in the database, the easier to get the subject’s story complete. However, the more care needed to get the true story. The logical, plausible subject story. Attention to medication given for an adverse event but missing in the concomitant medication list. Or laboratory shifts to worse results but missing corresponding adverse events listed.

Completing the holes in a puzzle is easy, for data management the edit checks help you tremendously with that. Getting a logical, plausible story for each patient, reflecting the truth, is the real data management challenge. Which takes more than just structuring pieces. It asks you to look and understand the pictures up on the pieces received.

Good luck with your data management puzzles,

Source:

“This is an article of ProCDM. Clinical data management training. Receive tips and the free e-book ‘Five strategies to get reliable, quality clinical data’ by subscribing via http://www.procdm.nl/pages/knowledgebase.asp.”

Comments? Join us at {EDC Developer}

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.

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