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Joint Effort: Cooking Workshop

Written by Anayansi Van Der Berg.

During the delicious Tai, Korean and Vietnamese Cooking workshop we learned some secret tips and tricks from the master chef as well as experimented with new cooking techniques. A fun way to eat in a relaxed setting and taste your colleagues creations!

Thai Gren Curry with Tofu
 

This dish was very easy to make. If you are not careful, or if you don't like hot peppers, then this dish might just be too hot.

We used tofu (as vegetarian replacement for meat) but you can make it with chicken, veggie chicken or pork. Serve tofu over the rice...

Izda: Thai Green Curry (Tofu with coconut oil, ginger, baby basil, 17 red and green peppers. Hot peppers! )

We believe spending time outside the regular work environment is key to improving our relationships not only with our colleagues but with our clients.

      Some benefits to this type of event:
  • Loyalty to our customers and employees
  • Unforgettable experiences
  • Building long-term relationships with our customers
  • New business development

This activity is jointly hosted by RA eClinica and RA Foundation, which provides support services to the community. For more information about non-profit events organized by this organization, click here!

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List of Validation Rules for SDTM Compliance

Written by Super User.

RA eClinical Solutions CDISC-CDASH-SDTM-ADaM Support

In 2014, the FDA published its first official list of validation rules for CDISC SDTM study data standards. These rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

With the help of the implementation guide, which provides documentation of metadata (data about the data) for the domain datasets that includes filename, variable names, type of variables and its labels, etc.; we can then map to the CDISC Analysis Data Model (ADaM) to be able to submit to the regulatory agency. This provides a clear content, source and quality of the datasets submitted in support of the statistical analysis performed by the sponsor.


Learn the basics on how to implement CDISC data standards concepts on your clinical trials from study design to FDA data analysis submission.

Need SAS programmers, CDISC Subject Matter Experts (SMEs) or a clinical programmer? We can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

Software Development

Written by Anayansi Van Der Berg.

Our consultants are available on contract basis, hourly rate or by project.

Microsoft .Net Developers

Our web developers work as virtual employees. They work exclusively for you, 8 hours per day and 5 days per week, report directly to the Sponsor's Project Manager or Functional Manager and communicate details of the developments as you require. Being constantly in touch through mail, WebEx and phone, you will feel the convenience of sitting in the same office.

Our Consultants have extensive exposure to:

  • VB.NET , C# and ASP.NET Microsoft .NET 1.1 / 2.0 / 3.0 / 3.5 Framework
  • MS SQL server 2000/2005
  • Knowledge of HTML, DHTML, Java script and AJAX
  • Knowledge of Web services, XML, XSL, RSS
  • Visual Studio .NET 2003 / 2005 / 2008
  • SharePoint Developer

RA eClinical Software Developers

Benefits of hiring .Net Developers from RA eClinica:

        • Source Code Authorization: All source codes will be owned by you
        • Dedicated person working just for you
        • Time zone: US EST, EU GMT timezone. We can accommodate based on each client's needs

Graphic & Web Designers:

      • Web Design Website development experience
      • Logo Design
      • Extensive exposure to HTML, Dreamweaver, DHTML
      • JavaScript
      • CSS
      • Photoshop and Dreamweaver
      • SWiSHMax and many more

Testers - Need someone to validate your system?:

      • Software QA
      • Performance Tuning 

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.

Technology Consultants

Written by Anayansi Van Der Berg.

Our consultants are recognized for their experience, capabilities and knowledge. RA eClinical Solutions dedicates a Professional Project Team to your project to assure its success. Our team provides expertise in eClinical and eCDMS study design and implementation.

Our primary goal is to work in collaboration with our clients to provide systems and services that meet their business needs, while ensuring complete compliance with all applicable U.S. and International regulations and guidelines.

RA eClinical Technology Consultants

We provide expert-level services in the following areas:

  • Data Management including CRF Design and Protocol Review
  • Data Cleaning activities including report creation and SAS Listings (SAS®, Cognos and IReview/Patient Profiles)
  • Database Design and Development (OC RDC, OpenClinica, Rave, Medrio and InForm)
  • The Electronic Clinical Study Project Management Life Cycle (ePMC™) provided by our eClinical Team is a validated process covering every aspects of the project management life cycle. The process manages the various stages of the study, including: Project Initiation, Planning, Execution, Monitor / Control, and Closeout.

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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