Pharma SAAS solutions must balance safety, efficiency: IQVIA
The pharmaceutical field was already undergoing a digital transformation when COVID-19 struck. After the pandemic landed, professionals faced even more challenges in the quest for improved efficiencies, reduced delays, improved security, and data integrity.
Outsourcing-Pharma spoke with Kevin Saylor, global head of the quality assurance systems compliance office at IQVIA about key questions pharma safety teams should ask when considering software-as-a-service (SaaS) solutions for their operations.
OSP: Could you provide a brief overview of your background, IQVIA, and what sets it apart from others in the industry?
KS: IQVIA harnesses the power of data to drive innovation in pharmaceutical R&D. As data plays an integral role in achieving patient health and business outcomes, IQVIA delivers new tools for data management, sources, and aggregation to streamline analysis and provide actionable, real-time insights for pharmaceutical customers to make well-informed business decisions.
My background is a bit unique: I started my career as an engineer with experience in system design and integration, utilizing technology to solve problems and improve processes efficiently. With this knowledge, I joined IQVIA to specialize in health authority regulatory requirements and empower pharmaceutical companies to meet their regulatory and R&D needs.
Additionally, we are constantly improving how customers leverage new system models and system design services. This is a significant component of improving quality assurance to align with regulatory compliance and high-quality products and tools.
OSP: How is the current focus on digital transformation in pharma affecting life sciences companies, HCPs, and patients?
KS: Data has always been critical for pharmaceutical companies to improve operations and decision-making. Digital transformation is extensive, creating a range of new sources of data and technologies available for integration for the first time.
As the amount of available data becomes ubiquitous from an increasing range of sources, we drive efforts to harness the information through digital transformation. The capabilities allow for the use of data, so it is easier to collect, combine and leverage into meaningful insights that gain significant results. For instance, data can help pharmaceutical R&D teams understand the safety and effectiveness of new medicines from clinical investigations and based on real-world use of the products.
Whether it is information by healthcare providers, real-world data, or actual medical practices, it can help identify trends and solutions. This data can then be replayed to regulators and the physician community to make informed decisions, such as treatment quality and efficacy for patients. When we understand which medicines are of higher quality, the healthcare ecosystem is empowered to improve the quality and advocacy of patients while delivering a better experience.
OSP: Why are so many pharma companies switching to cloud-based data storage rather than the traditional centralized data center?
KS: Many pharmaceutical companies are switching to cloud-based data sources and platforms. The core competencies required for system design and integration are much different than pharmaceutical product R&D, and which can be costly to maintain. The expansion of cloud-based platforms and tools has improved to the level where pharmaceutical companies can focus on the data management necessary for R&D.
Techniques and expertise for designing and engineering systems are innovating rapidly and becoming more centralized, making it expensive for pharmaceutical companies to be considered experts in everything. This enables companies like IQVIA, who specialize in these core competencies, to deliver a deep pharmaceutical experience in system design and cloud-based platforms while utilizing fewer resources. As a result, HCPs receive meaningful data insights and processes required to gather new data from clinical studies and real-world use cases of medicine.
OSP: What are some key challenges pharmaceutical companies can face when switching to gathering and processing data in the cloud?
KS: When switching over to the cloud, pharmaceutical companies must be confident in the underlying technology and its management. Previously, these platforms were created internally, but as it became costly and resource-intensive, these firms opted to streamline data management, establish best practices and data insights by working with a third-party partner.
Today’s cloud-based platforms are robust, well-developed, and more reliable, and there is no barrier to expanding pharmaceutical adoption of these tools.
OSP: What are some red flags safety teams should avoid when shopping for a SaaS-based platform?
KS: Pharmaceutical companies should be careful when evaluating prospective SaaS and cloud-based platforms, especially if the solution seems to over-promise or when the provider cannot demonstrate the quality of their system for key management and security topics. Cloud-based systems are regulated based on the processes they enable and/or the data they contain and manage. Any provider must first establish trust and partnership and a history of regulatory compliance.
Additionally, cloud technology providers must demonstrate the quality of the solution. It is easy for customers to be impressed with the critical functionalities of the platform. Still, the world isn’t static, and they must also watch out for plans and methods that handle user access controls, manage the deployment of future releases, and assist in adopting new capabilities. When providers have not considered how they will consistently deliver reliable, new capabilities, it could be a signal of future issues.
OSP: How can safety teams ensure that their solution meets data security requirements while also offering the same level of comfort that customers had with data centers?
KS: Drug and medical device safety are one of the most critical functions for pharmaceutical R&D organizations and health authority regulations. Therefore, it is critical to maintain proper governance over data operations continuously while also remaining transparent with customers. This shift in responsibility and control over the data has been underway in the pharmaceutical industry for over ten years.
Many pharmaceutical companies already outsource the physical hosting of large, complex technologies to providers specializing in these services. Most of these companies harness the real benefits and satisfaction in the service, expertise, and ability to focus on fundamental research activities.
OSP: How should safety teams work to ensure that their cloud-based platform keeps data protected?
KS: Both the customer and provider would mutually benefit from a long-term, evolving partnership rather than a one-time implementation project. As providers continue to enhance and develop new features, they can also test the platform at functional, technical, and security layers to ensure they provide a reliable, resilient platform into the future. In addition, providers should provide ongoing management and maintenance of the platform.
By creating a long-term partnership, the customer can manage their user access, network security, and similar features necessary to manage secure access and utilization of platforms. Jointly, the customer and provider should periodically review ideas for new capabilities and chart paths for these enhancements to confirm the best new techniques and technologies are leveraged. As a result, customers are equipped with the features and functions that they need, and systems are reliable, secure, and performing as intended.
OSP: Is there anything else you’d like to add that we have not touched upon?
KS: Regulatory compliance is a major challenge for pharmaceutical companies. If a regulatory standard changes, cloud providers can deliver new functionality into the platform to remain compliant more quickly than local customer-specific platforms.
In addition, providers can integrate new features in a “dormant” or “silent” mode until the customer decides to activate, avoiding any disruptions to the current function. Customers can also explore and adopt new features at a timeframe that works best for them.
