Dalia El-Sherif, Partner, Red Nucleus
Dalia El-Sherif, PartnerMaintaining compliance for life science organizations has never been more challenging. The increased regulatory mandates, public pressure to provide more transparency in corporate decision making, fragile supply chains, and many staff working virtually due to the pandemic make the role of compliance professionals critical to an organization’s success. For responding effectively, they today need more robust and streamlined processes, effective staff training and awareness-building programs, and software tools that allow them to anticipate future issues, not just react to events after they occur.

This is where Red Nucleus plays a vital role with its broad range of capabilities, including strategy and change, scientific services, and education and learning practice. The company exhibits a core domain expertise in supporting life science companies with compliance-related processes and activities. “We are a premier provider of learning, performance, and process solutions for the life sciences industry,” says Dalia El-Sherif, Ph.D., R&D Practice Head, Red Nucleus. The company combines cross-functional expertise, process-driven approaches, and proven methodologies to increase compliance, reduce cost, and enhance overall efficiency to provide clients with unrivaled capabilities.

Red Nucleus also helps clients drive compliance through a suite of product offerings, including DirectusPRO, a comprehensive, unique, global label management, tracking, and reporting solution. It addresses the market gap in providing a system that can effectively and efficiently enable a global end-to-end labeling process.

There are many challenges that life science company leaders face pertaining to compliance. For example, inspection readiness which continues to be a major area of focus for life sciences compliance. Businesses struggle with ensuring that CRO data is rightly collected and maintained in their repositories to make it available and searchable during an inspection. Furthermore, when companies bring in new systems or migrate from one system to the other, the cleanliness, completion, and organization of the data need to remain front and center so that it is also available and searchable during an inspection. And, increasingly, these inspections are now done virtually. That’s why Red Nucleus checks the processes in place to work with CROs, identifies any gaps or risks in the processes, updates them, and then follows through to ensure training is optimized to drive and instill consistency in operations.

Red Nucleus also has a comprehensive set of capabilities that support pre-and post-migration efforts and data and information mapping (ideally before the data is migrated, or support the mapping and clean-up after the migration has taken place).

Red Nucleus: Delivering Life Science Compliance In The Age Of Virtual Working

“Our broad approach, methodologies, and tool-kits support a wide variety of initiatives, and deliverables. Some of these tools are focused on and support inspection readiness to ensure life science companies comply with regulatory requirements,” says Dalia.

Our broad approach, methodologies, and tool-kits support a wide variety of initiatives, and deliverables. Some of these tools are focused on and support inspection readiness to ensure life science companies comply with regulatory requirements

COVID-19 has further changed the way life science companies operate. It has created a movement toward a culture of working from home, conducting clinical trials remotely, virtual inspections by health authorities, increased utilization of cloud-based systems, and transformation of the in-person training model. As a result, companies have had to find innovative ways to reach patients and collect data remotely, collaborate with health authorities and other stakeholders in different ways, and shift to virtual training and education models. To this end, Red Nucleus has been supporting clients in developing and implementing new working models to keep business productive and maintain quality standards. “We have been optimizing processes and training, supporting our clients to manage data and information as well as working to integrate and support new software and systems. We are witnessing a high-demand for our Organizational Change Management (OCM) services, which is ensuring positive change for our client stakeholders,” informs Dalia.

Red Nucleus consists of a dynamic team of experts who stay on top of regulations and trends to ensure that clients are provided with up-to-date information on meeting regulatory milestones and incorporating industry best practices. In one case, a large global pharmaceutical company was seeking to achieve the inspection-ready status of its clinical documentation for an upcoming FDA audit. They had recently migrated document systems and were unable to report on the status of the study documentation and make the necessary updates. The company required an assessment of their clinical documentation for multiple studies to perform remediation of any irregularities. The Red Nucleus team utilized their system, clinical, and documentation expertise to develop and execute a plan to deliver a thorough assessment of data to identify gaps, construct a remediation plan, and establish inspection readiness requirements. Within five months, the clinical documentation of the studies for the anticipated FDA inspection were updated in the new document system and submission records aligned to match the official submission register.

Last year, Red Nucleus also made strategic acquisitions to expand its capabilities and service offerings, including INVIVO, a leading digital scientific communications agency; the Life Science Training Institute (LSTI), a leading provider of live instruction, on-demand, and custom compliance training courses for the life science industry; and, most recently, iTakeControl, a mobile platform used to collect patient-reported outcomes and real-world evidence in virtual/home-based clinical trials and enhance data science in drug development. These strategic acquisitions, along with increased capabilities through our unique recruiting approach of both Strategy and Change consultants as well as scientific operations professionals, are a result of its success in helping clients meet their objectives while staying fully in compliance. “We bring a sense of urgency to every project; we know, like our customers, that the patient is waiting,” concludes Dalia.