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CDISC/CDASH Standards at your Fingertips

Written by Super User.

CDSIC/CDASH

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials.

There are some defiance in implementing CDISC in EDC CDMS:

1. Key personnel in companies must be committed to implementing the CDISC/CDASH standards.

2. There is an initial cost for deployment of new technology: SDTM Data Translation Software, Data Storage and Hosting, Data Distribution and Reporting Software.

3. It can be difficult to understand and interpret complex SDTM Metadata concepts and the different implementation guides.

4. Deciding at what point in a study to apply the standards can be challenging: in the study design process, during data collection within the CDMS [CDASH via EDC tools], in SAS prior to report generation [ADaM], or after study completion prior to submission [SDTM].

5. Data management staff [CDM, clinical programmers], biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.

6. Implementing new standards involves reorganizing the operations of (an organization) so as to improve efficiency [processes and SOPs].

7. Members of Data Management team must be retrained on the use of new software and CDISC/CDASH standards.

8. There are technical obstacles related to implementation in several EDC systems, including 8 character limitations [SAS] on numerous variables, determining when to use supplemental qualifiers versus creating new domains, and creating vertical data structure.

Anayansi Van Der Berg is a gold member of the CDISC organization providing support to CFAST projects. She is available for consulting projects.

Project Management Tools

Written by Anayansi Van Der Berg.

Our consultants are Certified Project Managers (PMP) and members of the Project Management Institute (PMI) – http://www.pmi.org

RA eClinical Solutions adopted EASY PROJECTS.NET as our primary project management tool.  EP.NET is a web application for managing and tracking tasks and projects.

Each client is assigned a ‘customer account’ that can be accessed anytime 24x7 from any computer connected to the internet.

Benefits:

    • Up-to-date project information is available to team members online in real-time
    • Project members can share files and notes
    • Email notifications keep project members updated  with recent information in real-time
    • Message boards provide the whole team, including the customer, with an opportunity to discuss any task or issue and keep a log of that discussion
    • More accurate customer quotations and billing
    • For customers that prefer Microsoft Project, we have a client/server application available, if needed.


PMP® Certification Exam Prep (contact us for more details)

 


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 4: A Full Data Management Solution

Written by Anayansi Van Der Berg.

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.

Case Study 3: Out-of-Box Solution

Written by Anayansi Van Der Berg.

 
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.

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Written by Anayansi Van Der Berg.

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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