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Tag Archives: Clinical Data Management

Case Study 4: A Full Data Management Solution

Case Study 4: A Full Data Management Solution

Working in a Collaborative Environment

The Scenario:

A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable.
RA eClinica Solution:

    • RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics and Programming.
    • RA eClinica preferred Data Management systems utilized with Sponsor’s Safety Surveillance system and Clinical Trial Management System, CTMS

Ra eClinica Results:

    • Study ongoing – All deadlines to date have been met or exceeded
    • Cost savings of approximately 35% in comparison to traditional CRO models
    • No turnover since study start

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.

 

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Case Study 3: Out-of-Box Solution

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

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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RAeClinica – Where Clinical Research meets Technology

eClinical Trial Technology, EDC, CTMS, and Technology Integration-Software Development – Web Development and Clinical Research Organization – Contract Research Organization

Source: RAeClinica – Where Clinical Research meets Technology

 

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Case Study 2: Supporting the Sponsor with Database Transfer Solution

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:

    • 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.

 
 

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Clirinx EDC

Clirinx EDC

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

 

 

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Castor EDC Demo

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.

 

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InForm EDC Features and Functionality

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.

 

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From Non-SAS Programmer to SAS Programmer Part II

From Non-SAS Programmer to SAS Programmer Part II

Previously, we wrote about how you can become a SAS Programmer with little or no programming background.

Today, I want to share a new link where you can download SAS Studio for free and practice. I have to give a thank to Andrew from statskom for the tip. Visit his blog for more SAS tips.

Here is a quick step on what you need in order to use the SAS University version for free provided by SAS:

1- Create a SAS profile and select the environment based on your operating system in order to download the SAS® University Edition. I  chose Oracle VirtualBox. The options available are: Oracle VirtualBox in Windows, Macintosh, and Linux operating environments.

2- You will receive an email where you can you download your SAS edition as per your selected environment on step 1. Click the link. It could take up to an hour for the entire program to download.

SAS University Edition

3-Go to https://www.virtualbox.org/wiki/Downloads to install the OracleVirtualBox.

4-Add the SAS University Edition vApp downloaded on step 2 to VirtualBox step 3.

OracleVM

5-Create a folder for your data and results.

6- Start the SAS University Edition vApp

7-Open the SAS University Edition by opening your web browser and typing  http://localhost:10080. From the the SAS University Edition: Information Center, click Start SAS Studio.

There you have it! You have now access to SAS and can start practicing your new programming language.

anayansigamboa sas studio anayansigamboa sas studio anayansigamboa sas studio anayansigamboa sas studio

For more information about the SAS University Edition, see the FAQs and videos at http://support.sas.com/software/products/university-edition/index.html.

For Data Management and EDC training, please contact RA eClinical Solutions.

 

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Good Documentation Practice (GDP) for the EDC / SAS Developer

When writing programming codes for either validating the software or for validation checks, we often have to write comments to explain why we did something.

Since the FDA regulates computerized systems used in clinical trials under the authority of Title 21 the Code of Federal Regulations Part 11 (21 CFR Part 11) – see my other article about 21 CFR Part 11 here, we need to make sure our codes and programs are documented. As you have heard before, if it is not documented, it never happened. Nevertheless, there is no mandatory regulatory agency mandating to have to do this.

GDP is an expected practice”

So how much documentation is needed? We could get into endless discussions of when we should comment, what we should comment, and how much we should comment. I have had plenty of discussions about comments with people with various opinions on the subject.

Here’s a good documentation practice for a SAS code:

For more information please visit the original post at: {EDC} Developer

Need a clinical programmer, Data Programmers (Oracle/SAS/.NET) EDC Specialists (InForm, RDC, Rave)?

Contact Us!

 

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Aside
ABSTRACT
Much effort goes into the specification, development, testing and verification of programmatic edit checks to ensure that the error rate in clinical trial data is sufficiently low as to have no statistically significant effect on the overall trial results. An analysis of several thousand clinical trials, containing over 1.1 billion data values and 1.1 million edit checks, shows that the majority of edit checks (60%) have no impact on data quality; none of these 678,000 edit checks have generated a single data query or discrepancy. What can be learnt from this analysis; can we reduce the overall number of edit checks without compromising data quality; can we identify the ‘high-performing’ edit checks and improve CRF design to avoid data entry errors; are there novel methods that might achieve similar standards of data quality with less effort?

 

Edit checks are necessary to ensure data quality reaches acceptably high levels.

Since programming edit checks takes time and resources, it’s important to ensure that the effort invested maximizes the benefit and re-usability of each edit check.

 

See attached document for full article information published by:
Optimizing Data Validation by Andrew Newbigging, Medidata Solutions Worldwide, London, United Kingdom

 
 

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Complexity and effectiveness of edit checks

 

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