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”.

 

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Are you Practicing GCP?

You probably heard news or stories such as Misconduct Delayed Drug Approval or Duke Settles Negligence Suit.

The Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki.

The first is to ensure the protection of the patient. The subject’s consent should have been obtained before any study procedure were performed. Each subject is monitor to ensure accuracy and completeness of the data generated.  If an SAE occurred, the monitor will confirm that the SAE has been reported promptly and completely.

The objective of the ICH GCP Guideline is to provide a unified standard practice for the United States, Japan and the European Union (EU) to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

So what are the essential documents during the conduct of a clinical trial?

1- Investigator Brochure documents relevant and current scientific information around the investigation product (IP) has been provided to the investigator.

2- Signed Protocol (including Amendments) and Case Report Forms (CRF) document investigator and sponsor agreements.

3- Informed Consent Form documents the information given to trial subjects.

4- Financial Aspects of the trial documents the financial agreement between the investigator/institution and the sponsor / research for the trial.

5- Signed agreement between involved parties. For example, sponsor and CRO.

6- Institutional Review Board (IRB) / Ethics committee (IEC) documents the trial has been subject to IRB/IEC review and given approval opinion. For example this includes but not limited to protocol and any amendments, CRF (if applicable), informed consent form, subject compensation.

7- Regulatory authority(ies) approval/notification of protocol documents approval/notification by the regulatory authority compliance with the applicable regulatory requirements(s).

8- Curriculum Vitae and/or other relevant document evidencing qualifications of investigator and sub-investigator as document eligibility to conduct trial and/or provide medical supervision of subjects.

9- Normal value(s)/range(s) for medical / laboratory technical procedures documents normal values of the tests.

10- Sample of label(s) attached to investigational product containers document compliance with applicable labeling regulations and appropriateness of instructions to the subjects.

11- Decoding procedures for blinded trials documents how, in case of an emergency, identify of blinded investigational product without breaking the blind for remaining subject’s treatment.

12- Master randomization list documents method for randomization of trial population.

13- Pre-trial monitoring report documents the site is suitable for the trial.

Note: Any or all documents listed in this guidelines may be subject to, and should be available for audit by the sponsor’s auditor and inspection by the regulatory authority(ies). Any revision to any of the above documents should be added to the files during the trial as evidence.

After completion of a trial, some other documents such as completed subject identification code list, audit certificate, clinical study report and final trial close-out monitoring report shall be available to document completion of the trial.

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. Basic Ethical principles refers to those general judgements that serve as a basic justification for the many particular ethical evaluation of human actions. Respect for persons where persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being.

Do not harm – hippocratic maxim

 Who ought to receive the benefits of research and bear its burdens?

An injustice occurs when some benefit to which a person is entitled to or when ought to be treated equally. This principle applies to the rights, safety and well-being of the trial subjects with most considerations and should prevail over interests of science and society.

Conducting clinical trials, in accordance with this principles of good clinical practice (GCP), makes it possible to test the effectiveness and safety of medicines, hence, it is important the understand the principles established in the guidelines.

Source:

http://www.ich.org/home.html and http://www.the-scientist.com/

Anayansi is 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)

Fair Use Notice: This blog/article/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.

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

HR: The Useless Department?

Everybody has a Human Resources horror story, which is why, in the words of one writer, HR is widely thought of as “at best, a necessary evil — and at worst, a dark bureaucratic force that blindly enforces nonsensical rules, resists creativity, and impedes constructive change.” HR, goes the refrain, is too important to be left to HR. [Forbes, 2013]

My experience goes for good, to bad to worse. In the consultancy business, you almost never deal with HR except during the interview process or during termination of contract (this includes, contract ending by contractual agreement or termination).

HR was useless

As an employee, I find this department to be useless because they serve their masters ‘the managers’ and not the slaves ‘the employees’. HR does what the manager wants. If they want to get rid of you or replace you, they will use HR to accomplish that.

You are fired

In other words, employees bring their concerns to the attention of the human resources personnel, and the response was less than helpful, and perhaps even made the situation worse.

If HR’s ‘real job’ is to cover up for poor morale and negligent behavior of line managers or executives then HR should be an extension of the general legal office and be staffed with attorneys to document everything, in preparation for either individual or class action suits.

dysfunctional organization

In the book, “How Organizations Empower the bully boss: a criminal in the workplace,” employees MUST understand there is no one in the organization willing to assist in any fight or survival of a hostile workplace with a bully boss. Workers are like a commodity treated no better than cattle in some workplaces where there is a bully boss waiting to devour them. I have witnessed the beaten up demoralized workers who were once exceptional, reduced to a far less productive individual, thanks to bully bosses.

Frankly, the only message I am sending to folks is protect yourself anyway you can because there is no one out there coming to rescue you from the bully boss or those who protect the bully-M.Veincentotzs

Conclusion:

Corporations have Human Resource Departments, it’s sickening when you recognize the language they use to describe us, but they won’t use the word slave as people would catch on too quick.  Egos like to have titles or at least identify others who have lesser titles than they.  It is always about who has more.  They fight each other using the slaves as their cannon fodder in their wars to determine who gets to control what, in the end the slaves never have a better future.

So how do we deal with the managers of the HR system that are doing what they are doing out of survival and ego? Questions or Comments? Join us on the discussion.

Reference:

It’s time for companies to fire their human resources department by Forbes, 2013

How Organizations Empower the Bully Boss:A Criminal in the Workplace by MARILYN E. VEINCENTOTZS, 2009

Justin is a Sr. Analyst / Consultant. He has been a dedicated SAS programmer for over 5 years now.

Fair Use Notice: This blog/article/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.