The pressure on contract research organisations (CRO) to maximise efficiency has been particularly pronounced over the past 12 months as the knock-on effects of pharma’s problems have been felt.
MDS believes the adoption of SAS will help its efficiency drive. The software provides integration and traceability of data from its initial capture through to submission and speeds its conversion into formats established by the Clinical Data Interchange Standards Consortium (CDISC).
This readies the data for electronic new drug applications (NDA) and the software can also convert it into the form requested by the Clinical Data Acquisition Standards Harmonization (CDASH) for electronic case report forms.
MDS has applied the software across its operations from preclinical through to Phase IIa. Integration also allows sponsors running SAS software immediate access to their clinical trial data, speeding the decision making process. Those without SAS software will still benefit.
Sponsors, as well as MDS, are also automatically alerted when new content becomes available. Furthermore, MDS believes the software can increase trust between CRO and sponsor by documenting the changes made to a piece of content.
“When sponsor and CRO work together across the shared and managed SAS technology infrastructure, they experience a tremendous leap in data sharing and review”, added David Handelsman, business solutions manager, life sciences research and development, at SAS.
Pharmas are increasingly entering into extensive outsourcing deals with service providers and in this environment the ability to closely monitor and collaborate on the project is desirable. By adopting the SAS software MDS believes it is equipped to prosper in this environment.