9 September 2014, Boston, MA – Sciformix Corporation, a leading Scientific Process Organization (SPO), 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 September 22-24.
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 optimized 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 like 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 September 23rd 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 operationalize 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 maximize 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.
To meet with Sciformix at DIA EDM 2014 and/or receive a copy of the presentation, contact us at Bizteam@sciformix.com .
For further press information please contact: David Bertram, The Scott Partnership: + 44 1477 539539 mail to firstname.lastname@example.org or Susan Najjar, Director of Marketing, Sciformix Corporation: + 1 617-264-0339 mail to email@example.com.
Sciformix Corporation is a leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies – in the areas of Safety and Risk Management, Clinical Research & Post-Approval Support and Regulatory Affairs. Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise to deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.
We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from pre-clinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.
Sciformix is dedicated to providing our clients outstanding services and solutions, fuelled by an unrivalled commitment to quality. We share the same level of involvement, dedication and passion as our clients and become an integral part of their team. Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results. Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.