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04.12.2016
5 CDISC conversions awarded to SchwabTech.
SchwabTech has been awarded the conversion of 5 legacy clinical trials to CDISC SDTM standards.
The client has taken advantage of a fixed price no overrun special of $45/k per trial conversion.
Once completed, additional SDTM conversions will be discussed.
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03.04.2016
SchwabTech awarded ISS/ISE contract.
SchwabTech selected for ISS/ISE comprised of 14 complete clinical trials. This project will
involve upgrading previous SDTM data sets as well as new mapping of legacy data. The use of standardized
terminology will greatly facilitate the future incorporation of additional clinical trial data.
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10.02.2015
SchwabTech Confirms Fixed Price No Over-run CDISC Conversions.
Due to extensive conversion experience, SchwabTech is able to provide fixed no over-run pricing for
CDISC conversions (SDTM and/or ADaM). Fixed pricing allows clients better control over budgets and overall fiscal planning.
The average time for conversions remains 5 weeks for SDTM creation and 6 weeks for ADaM after scheduling.
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06.22.2015
SchwabTech selected for multiple CDISC conversions (repeat business).
Additional clinical trials (11) created with in-house standard structures are to be converted to CDISC SDTM standards.
Subsequently, ADaM data sets will be created for generation of Table, Listing and Figures.
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10.15.2014
SchwabTech selected for multiple CDISC conversions.
Mutiple clinical trials (7) with data sets using in-house standard structures are to be converted to CDISC SDTM standards.
Additionally, ADaM data sets will be created and utilized to for Table, Listing and Figure generation.
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| Welcome to SchwabTech |
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SchwabTech
is an alliance partner offering a full range of
Clinical Data Management and Biostatistical services to sponsor
companies as well as contract research organizations. We have extensive clinical research
experience in multiple therapeutic areas.
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Presently, our high demand services are state of the art
CDISC conversions (SDTM and ADaM) and clinical data integrations (ISS/ISE and data mining). |
CDISC conversions:
Creation of Study Data Tabulation Model (SDTM) compliant datasets includes:
- Comprehensive conversion of all data to CDISC compliant SAS datasets implementing the latest production standards
(currently SDTM IG V3.2) with previous versions available (SDTM IG V3.1.1/2).
- Translation of data using production CDISC Terminology.
- Conversion analyzed using a battery of edit checks including the current OpenCDISC validator as well as a comprehensive set of standard edit checks to detect inconsistencies.
- Execution of project specific edit checks to further define any potential deficiencies.
- Complete documentation detailing the entire conversion process (conversion specifications).
- Define.doc
- Annotated CRFs
- Optional listings for data review.
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Creation of CDISC Analysis Data Model (ADaM) compliant datasets includes:
- Creation of all required ADaM datasets (ADSL and BDS structures (currently ADaM v2.1(IG 1.0)).
- Translation of data using production CDISC Terminology.
- Datasets analyzed using a battery of edit checks including the current OpenCDISC validator as well as a comprehensive set of standard edit checks to detect inconsistencies.
- Analysis dataset metadata specifications.
- Analysis variable metadata specifications.
- Analysis parameter value-level metadata specifications.
- Optionally, analysis results metadata (statistician/project dependent).
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Additionally, we specialize in the integration of data from multiple clinical trials into
a searchable comprehensive database that will support ISS/ISE analyses as well as any ad hoc endevours.
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With our experience, we are able to provide customized
solutions for the unique requirements of each
of your projects. Our dedicated staff prides
themselves on quality database creation as well as complete clinical trial analyses. |
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| Planning |
Implementation |
Execution |
| Trial Design Assistance |
Electronic Data Capture
Deployment |
Electronic Data Capture
Production |
Electronic Case Report
Form Development |
User Acceptance Testing |
Discrepancy Management |
Case Report Form
Completion Guidelines |
Database Validation |
SAE Reconciliation |
| Database Specifications |
Edit Check Validation |
Coding (e.g. WHO,
MedDRA, etc.) |
| Database Validation Plan |
Customized Data Listings |
Data Review |
Edit Check Specifications
Development |
Data Integration
(e.g. Lab, ECG) |
Database Lock and
Delivery |
| User Training |
Database Conversion
(e.g. CDISC) |
Project Documentation |
Data Management
Metrics
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SAS Programming
Services |
Transcription Services |
Rescue Services (may include any of the above)
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