For biopharmaceutical companies, speed has become the Gold Standard.
Faced with the accelerating pace of innovation, changing regulatory guidelines, extended development cycles, and increasing product development costs, pharmaceutical companies were already looking for ways to accelerate and sustain growth while increasing productivity internally and externally. Then came the record-breaking development of the COVID-19 vaccine — less than 365 days compared to traditional timelines of close to a decade — which revealed that strategic enhancements and do-or-die situations that challenge established processes can safely and successfully expedite clinical development.
Biopharmaceutical organizations are now considering approaches such as digitalization and virtualization, aligned with the next-gen technologies like cloud, cognitive computing, blockchain, and augmented reality, to accelerate clinical development. Businesses have been using cloud technology since the 2000s, but today’s pressures are pushing biopharmaceutical organizations to be more agile and move away from established approaches — even with cloud — that may delay product development.
Current clinical development is split among disparate technologies and data sources. Pharmaceutical companies are looking for unified solutions that can reduce time to market, increase agility and innovation, while strengthening business processes such as research and development (R&D), drug discovery, identification of safety issues, visibility of patient response trends, and reporting trial progress. Achieving all this is challenging, but organizations have had success with cloud-based, integrated platforms known as clinical cloud, which have enabled more collaborative research and clinical development.
Adopting cloud technology will provide biopharmaceutical organizations the capabilities they need to modernize their R&D processes and keep pace with changes across the industry. Rather than reinvent established processes, clinical cloud works to enhance operations by eliminating bottlenecks to increase efficiency, speed, and flexibility.
The benefits of adopting cloud
The cloud has long been a key enabler of new technologies and operations. It’s scalable, agile and therefore better suited than physical servers to handle large volumes of data, complex calculations, and new instances of applications. It’s also more accessible than on-premise servers, making it ideal for virtual collaboration and remote work. This combination of flexibility and accessibility makes cloud a reliable foundation on which to build digital infrastructures that can support a range of critical business processes, such as bioinformatics, next-generation sequencing, molecular imaging, and high-content analysis in the heavily regulated biopharmaceuticals industry.
A typical pharma ecosystem consists of various stakeholders: from physicians and research organizations, to clinical advisory boards and regulatory bodies, to pharma companies, IT services firms, and patients. Clinical cloud allows these groups to collaborate and leverage each other’s insights in ways not possible with the current infrastructure.
By implementing clinical cloud, pharmaceutical companies can reshape their relationships with patients, investigators, and scientists, moving beyond home-grown IT solutions to create enterprise-wide agility.
Reinforced IT and critical infrastructure
Pharmaceutical companies need to be able to adapt to change without compromising operations and critical infrastructure. Siloed IT and business functions make this difficult.
Mergers and acquisitions, for example, play a major role in the pharmaceutical industry. Integrating another company’s infrastructure requires significant orchestration and communication between parties. When IT and business functions are isolated and hard to access, it can be hard to facilitate these transitions, creating gaps in the combined operations. To achieve better outcomes, businesses need a unified, integrated platform along with integrated partnerships
Global collaboration between organizations helped expedite the development of the COVID-19 vaccine and is likely to become a new norm in the pharmaceutical industry. Effective collaboration, along with real-time, remote access to data, has become imperative.
Clinical cloud platforms provide a centralized space for all parties involved in the clinical trials to connect and collaborate. Investigators can connect with patients virtually and share data and insights with colleagues and on-site staff in real time. Flexible platform-as-a-service (PaaS) models further support scaling and efficiency. PaaS providers offer platforms pre-configured for the biopharmaceutical industry. Teams can choose the processes they want and make any final adjustments they need to meet their unique specifications for transition to collaborative, multichannel, on-demand operating models focused on improving patient outcomes.
Advanced data management
Research teams today deal with massive quantities of data from various sources that needs to be incorporated, analyzed, and shared with stakeholders who are often operating from different locations. Before teams can utilize this data, they need technology to help aggregate it, process it, and store it.
Cloud can handle extremely large datasets, making it essential to R&D programs. Storing data in the cloud also makes it easier for authorized users to access information, facilitating real-time interactions with collaborators, CROs, and allowing teams to share insights in ways not possible with legacy infrastructures.
Data management also requires strict security programs and policy management. Data regulations are constantly changing, especially from region to region. A global business needs to ensure that their data is secure not just in their locations but throughout the data supply chain, with every party along the line.
When organizations migrate operations to the cloud, they enlist the cloud provider’s security services as well, which tend to be more comprehensive than an organization’s internal security program. Cloud providers work with their clients to develop a security program that addresses immediate data-security needs while preparing to accommodate future changes in scale.
Enhanced digital capabilities and intelligent operations
Clinical cloud combines with other technologies to extend capabilities of innovation throughout the R&D cycle.
AI and machine-learning algorithms can help researchers prepare trials by identifying eligible participants and practitioners, analyzing data gathered from IoT devices, and generating deeper insights from larger datasets. Finding AI/ML experts and onboarding them can take months or longer. Clinical cloud algorithms support human AI/ML professionals, allowing teams to scale up without losing valuable time, providing insights both in a preventative and predictive manner.
Vendors are beginning to offer cloud models of R&D applications such as bioinformatics, next-generation sequencing, molecular imaging, and high-content analysis. Applications such as these share characteristics (extremely large datasets, complex calculations) that make them prime candidates for cloud migration. Clinical cloud further enhances these applications by providing real-time access to data, enabling faster application deployment (experiments, ad-hoc analysis), and supporting remote collaboration.
Ongoing progress: Enhancing, not replacing, existing R&D models
Development of the COVID-19 vaccine shattered all the vaccine development records. How were scientists able to do it?
Along with tremendous funding, development of the COVID-19 vaccine benefited from strong collaboration, shared access to tons of data, accelerated development, and expedited execution of clinical trials. A lot of experts and agencies worked together, sharing and processing data. They did not re-invent the wheel. They did not jeopardize safety or timelines by trying out new approaches. Instead, they diligently leveraged the right tools to help them perform essential tasks more efficiently.
Advanced data processing, deeper insights, greater access to information, better collaboration with peers: These are exactly the kinds of enhancements technologies like cloud and AI have been helping other industries achieve. For years, the biopharmaceutical industry has been hesitant to explore these technologies out of fear that doing so might create more issues than it would solve. However, the pandemic has shown that pharmaceutical companies can safely and successfully enhance their performance by using the right tools and technologies to upgrade conventional approaches rather than replacing them entirely.
The key is strategic implementation. Research and development teams can start by examining their clinical development cycles and identifying bottlenecks that tend to cost time and resources. Why are workflows restricted at a specific point? What capabilities or resources are lacking? This approach encourages teams to think of layering technology on top of existing processes rather than interrupting workflows to make it fit. If, for example, teams need a way to store and access large volumes of data, they might look to cloud-based platforms. If they need an efficient way to process all that data, they might look to AI.
What’s next: Digitization and virtualization is the future
The process optimizations clinical cloud provides will lay the groundwork for major enhancements in pharmaceutical development and clinical trials down the line. Cloud computing will enable pharmaceutical teams to process more data and engage with it in new ways, leading to the greater insights. Cloud-based platforms will support collaboration by making information more accessible to the stakeholders around the world.
This mix of scale and accessibility promises to safely accelerate the development of new treatments by equipping teams with tools to model and test treatment solutions before they invest significant time and resources in clinical trials.
Clinical cloud can also help pharmaceutical companies explore more customer-centric approaches that are less likely to be held up by time-consuming clinical trials. Consider the technologies used to identify subjects and investigators, patients’ engagement, remote consultations or treatments, efficient regulatory publications, and monitor safety events. All these have become possible today with the cloud-based platforms.
Cloud adoption is essential for today’s biopharmaceutical organizations to develop and deliver critical, innovative treatments faster. We believe any organization not leveraging cloud will underperform versus its competitors.
Dr. Rao Teki
Partner - Business Transformation
Dr. Rao Teki, is a digital transformation expert and thought leader with over 30 years of experience in the life sciences, healthcare, and medical devices industries. Dr. Rao consulting services for pharmaceutical and bio-tech companies include designing cloud-based platforms to accelerate drug development, scientific social-media-based IT solutions, and executing business innovation strategies on RWE, advanced analytics, EMR-EDC integration, digital biomarkers, social media and mobile solutions, and other clinical informatics.
Dr. Sarika Vanarse
Consulting Leader – Business & Technology Transformation Life Sciences
Dr. Sarika Vanarse is a consulting leader with more than 20 years of experience in pharmaceutical R&D, medical devices, IT consulting, and digital transformation. She leverages next-gen technologies to develop strategies, business and data architectures, and data-driven solutions for large digital transformation programs across the pharmaceutical and medical device value chain. She has a great track record of conceptualizing and designing cloud-based, digital architectures and outcomes-driven solutions that meet and exceed customer expectations.