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Tag Archives: EDC
Got Medrio? The Next Best EDC…
Medrio is a low cost solution that offers easy mid-study changes and intuitive phase I workflows.
One of my favorite features of Medrio is the Skip logic functionality. So what is Skip logic?
Let’s demonstrate this feature by using the Demography form / Race field:
In many EDC systems that I am currently using or used in the past, we have to create separate fields for each option and write a custom edit check to flag when data has been entered under the specify field. This scenario request data on the specify field if the OTHER race option is checked but with skip logic, no other option will be allowed to enter data (e.g. White or Black or Indian) if the user did not select OTHER as an option and the required field ‘Specify’ is made visible and available (mandatory) for data entry.
Medrio
In the above screenshot, the query resulting from the skip logic configuration if OTHER specify is not completed. In other words, when Race other than ‘OTHER’ is checked, the specify field will be skipped (not enterable). To make this work and as a best practice, you will need to make the ‘OTHER’ field required during data entry.
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.
Source: medrio.com
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.
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, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”
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:
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- 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:
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- 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
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.
Case Study 2: Supporting the Sponsor with Database Transfer Solution
Assisting the Sponsor with Database Transfer Solution
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:
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- 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:
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- 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.
Introducing OpenClinica Participate
This webinar showcases our mobile-ready patient engagement and ePRO solution and will cover how this innovative technology can help you capture patient reported outcomes.
Source: Webinar delivered by OpenClinica CEO, Cal Collins and hosted by Marketing and Communications Manager, Rob Rittberg
Clirinx EDC Demo
Quick overview of Clirinx EDC
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 of EDC systems, please contact us
Castor EDC Demo
Castor EDC Training and Support
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.
InForm EDC Features and Functionality
InForm 4.x Training
Learn the differences between 4.5 and 4.6 and new features
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.
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.
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}.
ClinCapture® Tutorial – How to enter a patient schedule a visit and start entering data
ClinCapture® Tutorial – How to enter a patient, schedule a visit and start entering data – YouTube.
ClinCapture® is the most advanced open-source electronic data capture (EDC) system designed to streamline your clinical trials. As an open-source solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials.
ClinCapture® can be rapidly deployed and easily adopted, customizable to specific study requirements. ClinCapture® is repeatedly chosen as a preferred EDC solution because it is intuitive, flexible, and proven.
Source: Clinovo
FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”
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