Milano, 20 febbraio – When a new drug application is filed with the U.S. Food and Drug Administration (FDA) for review, millions of pieces of data about the drug development process and clinical trials accompany it.

Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical research and development, helps drug-development companies of all sizes with this process. Octagon has turned to SAS, the leader in business intelligence, for powerful data integration technology to streamline the electronic submission process of its customers by helping them convert diverse data to the required standard format.

“SAS has vast experience in the life sciences industry, and was a logical partner for us,” said Octagon’s Chief Information Officer David Evans. “Through its SAS® Data Integration Server, SAS gives Octagon and our clients powerful, validated technology that brings together data from disparate formats and fits easily within our standardized process for ensuring compliance with the latest industry standards like SDTM.”

The Study Data Tabulation Model (SDTM) data standard was developed by the Clinical Data Interchange Standards Consortium (CDISC). The FDA has requested in Guidance that all electronic data submitted for review adhere to this standard. The industry anticipates that in the future, the FDA will mandate use of SDTM. Having data presented in a standardized way improves the ability of FDA reviewers to evaluate the data and helps speed the approval and release of effective and safe new drugs.

Octagon’s pharmaceutical customers spend years gathering the data needed to prove the efficacy and safety of their drug compounds. This data is often from diverse systems and in varying formats.

“Our clients big and small have been working on their studies for years and years. They want confidence that the data Octagon helps them submit adheres to all relevant standards like SDTM, and includes a complete audit trail to comply with regulations like 21 CFR Part 11¹,” said Dan Crawford, Octagon’s Director of Data Integration and Standardization. “With SAS, Octagon can deliver this confidence. We rely on SAS technology as we develop customized conversion routines for each Octagon client. This attentiveness to the individual needs of each pharmaceutical customer is what sets Octagon apart, and SAS and its data integration technology help us better serve them.”

(1 21 CFR Part 11 refers to the Code of Federal Regulation issued by the FDA that mandates the criteria for trustworthy, reliable electronic records)

SAS, a CDISC Registered Solution Provider, is committed to the development and implementation of data standards in life sciences and has been a CDISC member since 2000. SAS solutions such as SAS Drug Development and SAS Enterprise Data Integration Server support CDISC standards, and SAS consultants help organizations implement these standards.

A major component of the SAS® Enterprise Intelligence Platform, SAS Data Integration Server supports initiatives requiring data cleansing and enrichment; data consolidation and migration; data synchronization; data warehousing; and master data management.

About Octagon Research solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, Pa., with European headquarters in Amersham, UK. For more information, please visit www.octagonresearch.com.