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| Case Studies |
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| CDISC ODM Gateway for Data Interchange between Clinical Systems |
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Problem area:
Data interchange and integration between internal Clinical Data Management Systems
Solution:
LAXAI implemented the data interchange and integration using CDISC Operational Data Model. An ODM gateway was built which can process data as XML files. Existing operational data was stored in relational data bases. Adapters were custom built which can read operational data and segregate Administrative, Clinical and Audit trail information and store it as an XML file. ODM gateway was built as a dynamic link library which could be readily used on windows platform. The ODM gateway is capable of both generating and receiving files which are above ODM version 1.2. Validations are in place to validate against CDISC schema. The ODM gateway application also features an ODM Viewer which can generate the clinical data in a user friendly format. The tool confirms to 21CFR11 regulations and provides security features including access privileges to information.
Benefits:
Easy integration with multiple CDM systems in a unified and manageable CDISC ODM format which is endorsed by the industry and centralized management of data. The tool is easy to use and encapsulates the need to understand technology or programming knowledge to use CDISC ODM standards. |
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| CDISC SDTM compliant global libraries |
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Problem area:
SDTM compliance is often viewed retrospectively as a Biostatistics function, and involves a lot of time and effort to achieve. Moreover if the CRF design doesn't handle certain required or expected variables, it would jeopardize the effort of data standardization.
Solution:
LAXAI implemented a global library of standard Case Report Forms which are SDTM compliant. The Standard CRF forms were recreated based on SDTM Implementation guide 3.1. Data elements in the CRF were re-grouped to fit the SDTM model. Emphasis was to ensure 100% compliance regarding the Required and Expected variables. Permissible variables and Supplementary Qualifiers were utilized to fit the variables. Initially SDTM+ datasets were generated; these datasets contain more information than what is required by SDTM standards. Non-compliant variables were removed using SAS macros and fit as SUPPQUALs.
Benefits:
This solution addresses integration / data transfer related issues between the Data Management and Biostatistics teams. Part of the issue is addressed when SDTM standards are adhered at the time of CRF design. There is a better clarity on data types, variable length, variable naming convention, dataset names. Also, SAS programming effort is minimized in generating SDTM compliant datasets, most of the work is carried out already by the CDMS system at the time of data capture itself. |
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| Leveraging the Offsite model to improve efficiencies |
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Problem area:
Outsourcing critical functions is a challenge, but the need to optimize still exists.
Solution:
LAXAI's client, a mid sized bio-pharmaceutical company in the United States was looking for an outsourcing partner for their Biostatistics and SAS Programming needs. The client was not comfortable offshoring the work outside the United States due to the criticality of data involved. LAXAI suggested an offsite engagement model where the programming and Biostatistics functional services would be executed from its South Plainfield, New Jersey solution center. The entire team comprising of Project Manager, Biostatistician, SAS Programmers and QC team was based out of the New Jersey office and the project was completed in record time resulting in significant cost savings to the client compared to the traditional onsite resourcing model.
Benefits:
Offsite model results in enhanced productivity for the clients without the need to manage the day to day activities of the project and enables clients to focus on critical business functions. Moreover, this outsourcing model ensures constant communication betwen the client and the project team to address issues immediately. This model provides better transparency in the day to day activities and eliminates the surprise factor which is often associated with 100% offshore outsourcing. Moreover productivity is enhanced as the Offsite team acts as an extended arm of the client's team providing business continuity due to unforeseen contingencies and resource shortages. |
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| Achieving cost savings with Blended outsourcing model |
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Problem area:
Project management and timeliness in outsourced projects.
Solution:
LAXAI's client, a US based academic institution decided to outsource the Data Management and SAS Programming functions of a NIH funded study to achieve cost savings. LAXAI's team processed the entire CRF data along with the interim analysis reports from its Hyderabad facility and NJ facility in a record time. Tasks included CRF design, data entry, discrepancy management, SAS data extracts and Analysis Reports. Since some of the Clinical Trial Sites where in India, LAXAI's India presence provided the locational advantage and produced significant cost and time savings.
Benefits:
Blended model provided the flexibility of a pure offshore model with a better control due to offsite presence in New Jersey. The cost savings were considerable compared to the previous study where Data Management and Analysis were carried out in the US alone. |
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