Biometrics, Data Management, Medical Writing Through Stage III
Spaulding Clinical, a full-service Phase I clinical service provider, today announced expanded services for clinical trial Phases I through III, including biometrics, data management, and medical writing. While approaching their 15th anniversary and coinciding with the company’s concurrent rebranding and new website, Spaulding’s deep experience and expertise in these areas can now be utilized in other phases of the clinical trial journey.
“Spaulding Clinical has featured paperless electronic data capture since day one and has long been First in Phase I clinical trial services,” said CEO Cassandra Erato. “Expanding our service offerings to fulfill the needs of Phase II and Phase III trials is a natural evolution 15 years in the making, and we debut these services to the later-stage market with well-honed processes already in place and executed by a uniquely experienced team.”
Biometrics
Data is exported and analyzed directly with Spaulding’s SAS programming/services, resulting in time and cost savings by eliminating the traditional EDC system middle step. The Spaulding statistical programming team is experienced in CDISC standards and develops analysis datasets to ADaM standards, providing a fully annotated version of the Pinnacle21 (aka OpenCDISC) report outlining any discrepancies from the standard. They will also create the TLFs to match the shells outlined in the SAP.
Data Management
Spaulding uses a CDISC ODM certified eSource system. It is a web-based, electronic data capture, data management, and eSource system with data entry and data viewing being supported in real time. As data is entered into eSource, this allows for immediate review by sponsors and monitors, thus preventing error or breach of private health information.
Medical Writing
Spaulding’s medical writing team provides a full complement of services to support your study from protocol writing through publishing, including data interpretation and delivering quality documents that are fully compliant with ICH guidelines and regulations. Spaulding’s medical writing quality control processes ensure published outputs are consistent and compliant with overall submissions, including capability for eNDA full publishing and eCTD format.
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