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- Written by Anayansi Van Der Berg
One of the challenge pharmaceutical and biotech companies faced today within their Clinical Data Management is the rapid changes and improvements in data management/capture technology.
Electronic Data Capture tools such as Oracle InForm and Medidata Rave allow for obtaining large sample sizes with reduced unit costs through global access, fast interaction, and automation. They provide a fast and easy avenue for the acquisition of scientific data, and this method of data acquisition will become much more common place in future multi-center clinical trials.
The implementation of EDC system eliminates the need for double-key data entry as the system automatically checks for inconsistent, illogical or missing data. In EDC, most of the data management planning and implementation are completed even before data entry is initiated. The annotated CRF, database design, and the vast majority of edit and logic checks are finalized prior to enrolling the first subject. The CDM can now look at the data in real-time, and begin the generation of data listings and identification of potential problems early during the course of a study. Training for CDMs in this new global environment, must accommodate this change in technology and shift in the clinical data management paradigm.
THE GOALS OF GLOBAL CLINICAL DATA MANAGEMENT
- Provide Electronic Translation Solutions: Developing translation software to transform data reliably from a variety of sources into a standard readable format.
- Develop Data Management Standard Operating Procedures (SOPs): Following Good Clinical Practices (GCP), and GCDMP in a standard way on a global scale.
- Verify Data for Protocol Compliance: Global standards in assessment of all image and non-image data to ensure proper display format, data integrity and conformance to protocol in accordance with FDA (and/or other) regulations.
- Develop Global Standards in Archiving of Original Data & Back-ups: Provide archive solutions based on the size and type of data sets involved in the trial and the sponsor’s needs. Utilization of a secure on-site data storage facility to house electronic backups of all trial data in compliance with GCP disaster recovery requirements.
- Track Patients and Workflows: Training of Research Associates to electronically monitor all trial data workflows. Providing the sponsor with access to this workflow via a secure link (web interface).
- Provide Sponsor with Electronic Access to Database: Providing sponsors with access to trial data via a secure link (web interface).
- Create Database of Data Analysis Results: Extraction of trial data and submission of it in sponsor-specific database formats.
- Digital FDA Submission: Digital databases of images, reports, and analysis should be suited to be submitted electronically (digitally) to the FDA (and/or other regulatory agencies).
- Timely Transfer of Data to Sponsor.
Reference:
Allan, Nick: Training for a Global Clinical Data Management Environment (2007)
Our certified Medidata Rave consultants and trained InForm staff will be able to provide and support EDC development from project planning through database lock whether on-site or offsite.
Not only we can provide training but we are committed to delivering quality service to your organization or CDM department.
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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Data Management Support
- Programming, testing and maintenance of databases (OpenClinica, Medidata Rave, Medrio, OCRDC, Clintrial, Oracle InForm and many more)
- Creation of case report forms (paper CRF and EDC)
- Creation of data management plans (eDMPs)
- Planning and Programming of the validation checks
- Query Management (Creation the DCFs and incorporation of the Query retrace)
- Encoding of AEs, medical history and concomitant medications (ICD, MedDRA, ATC)
- SAE Reconciliation
- Quality assurance measures
- Development of data management structures, standards (eg CDISC) and SOPs
- Conducting training of data input and management staff
- SAS Programming
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 partnersin 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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- Written by Super User
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 report quality 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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