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Technology Consultants

Technology Consultants

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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Posted by on December 8, 2015 in eClinical, EDC, Freelancers, Outsourcing, SMEs

 

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The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials.

Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients.

If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

  1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer.
    Some of the skills you should learned are:
  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations.

Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion:

Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

Need SAS programmers? 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.

 

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CDISC/CDASH Standards at your Fingertips

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.

RAeClinica, an EU-based/Latin American company that can help to manage the transition of your clinical trial to CDISC compliant data standards. We are well informed of the new standards and changes to be released and we can help demystify the guidelines, standards, and processes for your company. Using the powerful engine such as Medidata, Oracle InForm, Oracle Clinical, CMED or OpenClinica, RAeClinical has developed a CDISC compliant standard study design that takes advantage of the benefits of CDISC standardization: decreased study start-up and design time, increased data quality, decreased data redundancy, improved data integration, enhanced scalability and re-usability of global library infrastructures in our Clinical Data Repository, facilitation of data interchange and the ability to exchange and use information with external vendors, decreased time to FDA submission and review of regulatory submissions.

RAeClinica, a consultancy and technology company, offers data management services as well as customized software solutions. This expertise paired with an acute understanding of the CDISC/CDASH initiatives makes RAeClinical an ideal partner for your data management needs.

For more information on the benefits of CDISC and CDASH and what we can provide for your clinical trial, please visit us at raeclinical.wordpress.com or contact us.

 

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