- Details
- Written by Super User
RA eClinica Solutions (Technology Resource Organization), is your best source for customized solutions. We focus exclusively on clinical drug development in the bio-pharmaceutical industry, we addresses a highly specialized need in an extremely large and growing market with an avid demand for qualified personnel. RA eClinica combination of clinical trials development expertise with technology integration and recruiting resource, allows each of our clients to 'custom design' their required needs.
RA eClinica collaborate with each client to develop a solution with our experienced 'SMEs' of professionals. Each team is trained in a specific functional area to ensure that each of our clients' need are met. This approach differs from the turnkey approach of Clinical Research Organizations (CRO) employment and the low value-added commodity style of general staffing / recruitment firms.
Our dedication to serving each of our staff as well as our clients, has earned us a reputation as a reliable source of opportunities in the following areas:
| Clinical Programming | Clinical Research | Biostatistics |
| Clinical Data Management | EDC Developers | SAS Programmers |
| IT Professionals | Data Managers | Project Managers of Data Management |
If you are looking for contract staff (short and long term), permanent staff, "contract to perm" employees or project team deployment, let us help you find the right candidate.
Take advantage of everything that RA eClinica Solutions has to offer you. My colleagues and I look forward to the opportunity to work with you in the near future.
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.
- Hits: 2889
- Details
- Written by Super User
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.
- Hits: 3199
