Sciformix to Present New Change Management Model for Regulatory Operations Outsourcing at DIA EDM 2014

Sciformix Corporation will unveil a change management model for outsourcing regulatory operations and eCTD submissions at this year’s DIA EDM meeting, which will take place in Washington, DC on 22–24 September 2014.

The new outsourced model will allow life science companies who make regulatory submissions electronically to reap significant cost savings and improved compliance through increased efficiencies in the end-to-end submission processes via optimised resource management and process standardization.

Before embarking on an outsourcing partnership, companies need to establish a few critical processes such as setting up an appropriate governance structure; appointing a relationship manager; establishing a proactive way of managing feedback between the partners; and agreeing on parameters such as costs, processes and timelines so a transparent and collaborative environment is established. Partners need to establish how outcomes will be measured relative to the client's needs, be that service-level metrics or deliverables.

The model designed to address these critical processes in the context of regulatory operations will be presented by Darryl Clarke, Director of Regulatory Operations at Sciformix, at the Omni Shoreham Hotel in Washington, DC 23 September at 3:30pm. The presentation, entitled ‘Change management — Outsourcing Regulatory Operations and eCTD Submissions’ will outline the change management model, the reasoning behind companies looking to outsource their regulatory operations, and the concerns the industry has with regards to the internal user adoption of employing an outsourcing partner. The presentation will go on to provide best practices of how companies are successfully integrating outsourcing in regulatory operations.

Mr Clarke, commented: “It is no secret that with the ever-tightening and dynamic regulatory landscape, maintaining efficient and compliant regulatory operations is of paramount importance across the life science industry. Companies must have the ability to change and operationalise processes quickly to remain compliant. Regulatory change presents a significant challenge to life science companies, specifically small to mid-sized companies operating in emerging markets with limited technology and infrastructure. In addition, large companies now require new processes and expertise to manage full audit trails and compliance.”

He continued: “Embracing change management is critical to success in this fast-paced environment, and together with enabling cost savings through process standardization and increased efficiencies, this change management model for outsourcing regulatory operations will provide flexible and cost effective means of managing the peaks and valleys in regulatory submissions.”

Following the success of last year’s combined EDM and ERS/eCTD event, DIA EDM 2014 will continue to explore evolving global trends in e-records, systems and e-content in the clinical and regulatory space. The rapid evolution of global electronic initiatives necessitates industry to continually assess internal processes to maximise content reuse and streamline efforts by pushing submission-ready content and data standards farther upstream. This conference serves as a forum for discussion of emerging standards and processes for submission creation and maximum use of regulatory information.