Statistical Programming

Whether a pharmaceutical, biotech, medical device or e-Clinical company, eClinical Solutions, a division of Eliassen Group, works with you to build your organization with quality services and experienced resources at the right time.

eClinical Solutions works with major pharmaceutical companies as a preferred services provider of SAS programming and reporting analysis for Phase I-IV clinical trials. We have a solid team of experienced SAS programmers, many of which are SAS Base and/or advanced certified and have on average 3-5 yrs pharma/biotech experience programming listings, tables, graphs across all phases and TA's.

eClinical Solutions also provides clinical data mapping and legacy data conversion services whereby legacy data is mapped to new data standards ensuring compliance as the standards change. Our team develops the logical data maps followed by statistical programmers, as well as the application programs to affect the data transformation following specific system validation guidelines. We develop the migration plan that includes mapping specifications from source datasets to target domains. The team follows audit procedures to ensure data quality such that clinical results do not change as a result of the mapping to the new data standards. Our team has experience mapping into CDISC and SDTM compliant datasets as well as client specific data standards.

We also have an internal training program which covers "best practices" and methods in clinical programming in addition to technical training.

We strictly enforce the following QC steps to ensure highest level of quality in programming:

• Validation of programming specifications.
• Code review and validation.
• Data quality checks.
• Standard QC check lists are followed at various stages of clinical programming and data transformations.
• All QC results, actions taken by programmer, and resolutions of such results are documented and archived.
• In case of use of client specific reporting environment, we also follow the QC checks related to the specific environment. We also work with the clients and develop the workflows/processes that best fits the project.

eClinical Solutions is uniquely qualified to deliver the Statistical Programming services in an Functional Outsourcing model due to our knowledge and experience with the business model. Our experience in deploying, executing and scaling the Functional Outsourcing model separates us from the competition. We are currently providing over 100 resources in a Functional Outsourcing model performing clinical programming services for a large pharmaceutical company. See more information on our Functional Outsourcing model.

Project teams are located at eClinical Solutions facilities near the client, onsite at the client location, and/or at eClinical Solutions offices, depending upon client requirement, and project needs.

Learn about all of our delivery models.