Many small, medium and large sized organizations have their safety data in disparate systems, and as a result this makes it difﬁcult to access and view their data, make informed decisions, and manage reporting to regulatory authorities. Due to growth through mergers and acquisitions, many mid to large organization may have multiple subsidiaries, each with safety data in disparate systems. Smaller organizations may engage multiple CROs for their clinical trials which also means that their safety are in disparate systems. For whatever the reason, safety data is not always integrated and is being managed at different levels of effectiveness, which results in a lack of control. Many organizations seek to implement an integrated, consistent, validated, and secure best-of-breed safety solution.
A global pharmaceutical company that is actively engaged in R&D and offers prescription drugs across a wide range of therapeutic areas including Oncology, Gastroenterology, Antidiabetic, Antibiotics, Cardiovascular, Pain Management, and Gynecology sought to implement an Oracle Argus Cloud solution within a very stringent timeline.
Given the signiﬁcant project requirements and impact to the business, the Sciformix Accelerator Methodology was proposed and implemented. This ensured that all project timelines would be met and a robust, validated, and secure solution would be delivered. This methodology consisted of three main components:
- Structured Program/Project Oversight and Management consisting of formal processes that facilitate effective communication among integrated cross-functional teams, effectively manage issues, and ensure quality at every stage of the project
- Comprehensive IT Global Quality Management System (QMS) designed in accordance with ISO 27001:2013, ISO 9001:2008, ITIL V3, GAMP, ICH, and other global best practices to conform to the highest levels of quality, regulatory and compliance standards
- Virtualization Methodology and Standardized Validation designed to speed up project timelines and ensure comprehensive quality across both the application and operating environments
By implementing a ﬂexible and integrated team structure, best-of-breed IT QMS and virtualization methodology, Sciformix was able to deliver a high quality validated solution in a record time of 38 days. The Client achieved better consistency and control over their drug safety continuum with a standardized safety technology environment, attained a cost-eﬀective and uniﬁed system infrastructure by avoiding contracts with multiple legacy providers, realized a secure single tenant architecture with changes and planned system management downtime aligned with their business needs and experienced enhanced quality and compliance by being in a state of audit-readiness.