Fran Bates, VP, Technology Services, Sciformix Corporation
Pharmaceutical and clinical stage companies often store their safety data in disparate or legacy systems, due to mergers & acquisitions and/or clinical trials being led by multiple CROs. This can make accessing, viewing and analyzing safety data as a whole difficult, limiting a company’s ability to make informed decisions, ensure patient safety and manage regulatory requirements.
In these scenarios where safety data isn’t integrated and data management is compromised, leading to a lack of control, many organizations seek to implement a seamless, validated, and secure best-of-breed safety solution. Migrating data to the cloud gives companies efficiency and leverages cost savings that internally hosted applications are unable to provide.
Case Study Example
While integrating safety data systems is essential, such a project can be complex since multiple data migrations are required from different data constructs, and a single validated drug safety technology system requires organizational agreement on its functionality.
A top global pharmaceutical company, offering prescription drugs across a wide range of therapeutic areas including Oncology, Gastroenterology, Anti-diabetic, Antibiotics, Cardiovascular, Pain Management, and Gynecology, required a single, consistent system for regulatory reporting, and sought to integrate two safety databases from different subsidiaries into a single Oracle Argus platform.
Delivering a high quality validated solution
As integrating safety data systems is a significant task, with impacts across the organization, it was sensible for this organization to select a drug safety software technology and services partner experienced in similar projects. Outsourcing this activity can be an efficient way to ensure project timelines are met, and the functionality required is delivered. A partner with such experience will execute on a proven implementation methodology, with specified deliverables and pre-validated software configurations.
"Finally, virtualization methodology and standardized validation speeds up project timelines and ensures quality across both the application and operating environments"
The structured Sciformix Accelerator Methodology consisting of the following three components was used to seamlessly and rapidly implement a robust and quality solution for this customer in record time:
- Structured project oversight and management,
- Comprehensive IT global quality management systems
- Virtualization methodology and standardized validation
Structured project oversight and management utilizes formal processes that facilitate communication and hand offs among the multiple partner stakeholder teams (Safety Functional Experts, Technology Infrastructure, Compliance, Clinical, and CROs) to effectively manage the tracking of activities and resolution of issues that arise, ensuring quality at every stage of the project.
Experienced providers are able to quickly respond to client needs and effectively employ operating processes by assembling a dedicated team of technical and business experts to develop and implement the system. These specialized resources mean that client employees can focus on their core jobs and only be engaged when required to ensure that the project remains on track and is delivered in the required timeline. A dedicated functional QA specialist is assigned to ensure quality throughout the project. Additionally, a formal and robust issues management procedure allows for seamless resolution of any issues during the lifecycle of the project.
By managing the project end-to-end, an outsourcing provider can hold demonstrations and workshops throughout the process. This ensures all users are familiar with the system and provides an opportunity for the solution to be adapted to user requirements and to propose technical solutions to problems. By employing a model where teams work together as a whole, while also having individual departments responsible for each function/role (as defined in Table 1 below), the project implementation can predictably progress. A comprehensive IT Global Quality Management Systems (QMS) designed in accordance with ISO27001:2013, ISO9001:2008, ITIL V3, GAMP, ICH, and other global best practices insures that the solution conforms to the highest levels of quality, regulatory and compliance standards. This Sciformix state of the art quality systems incorporate the latest regulatory guidance principals from around the world.
Finally, virtualization methodology and standardized validation speeds up project timelines and ensures quality across both the application and operating environments. Using these concepts in tandem with an IT quality management system allows a high quality, functionally-rich, accelerated and productive client-specific Argus safety cloud deployment. When developing the QA environment, a ‘gold copy’ can be created in order to reduce the validation level of effort (by having preapproved work instructions) and deployment efforts to commission the solution in only a few days.
Implementing a drug safety technology solution with an established partner who can offer a flexible and proven project approach and structure that enables life science companies achieve better consistency and control over their drug safety data is an imperative for delivering safe and effective drugs. Additionally, life science companies can also look to maintain a cost-effective and unified system infrastructure by avoiding contracts with multiple legacy providers. Finally, they can reap the benefits of a secure single tenant architecture with controlled/planned system changes and system management downtime, which enable continued compliance and a constant state of audit-readiness.