The pharmaceutical industry has accumulated siloed operations and disconnected data in the quest to bring medicines to patients. For example, in clinical trials, the average company uses five applications to manage operations, and 33% use six or more.1 As life sciences companies embark on digital transformation, they face significant challenges in variable timelines and costs—on average, ten years and more than two billion dollars—that are typically required to bring a new treatment to market. Today, 80% of the world’s top life sciences companies use cloud solutions. Projections also call for cloud-based solutions to create $1 trillion in new value for the industry by 2030.3 For IT leaders considering a cloud platform approach, below are practical learnings from life sciences for change management, continuous improvement, and new technology implementations.
Success often depends on leveraging the value within raw data to make usable information accessible sooner across functions. Global teams in clinical, R&D, manufacturing, regulatory, quality, and commercial operations need to be connected and working in concert. The goal is to have one source of data and a consistent flow of information across these functional groups.
Like many other industries, cloud solutions have helped these efforts by standardizing operations, processes, and workflows and integrating data for improvements in speed and agility.
Fostering Connection to Drive Greater Collaboration
Connecting research and development functions like clinical, regulatory, quality, and safety on a single platform to streamline end-to-end processes represents a significant change from the industry’s traditional data management practices. In the past, functional areas typically made system choices independently. They selected the best solutions for their needs without considering the overall landscape. The result was a myriad of technologies that had to be stitched together, with minimal alignment across teams.
Likewise, sharing data with other departments meant that it had to be cleaned and reconciled. Even duplicated data points could contradict each other, and the way data was managed made monitoring and reporting difficult, impeding continuous improvement efforts.
Today, even though cloud technology can support more holistic processes, functional groups have become accustomed to siloed ways of working. Realigning processes often requires a significant change in management efforts.
IT leaders and teams should bring together stakeholders from different groups and secure buy-in for an IT strategy that spans functions to embrace a bigger, unified picture. Moreover, this will enable better collaboration and deliver the potential for improved connections from the start.
Governance and Standards are Essential
Establishing well-defined governance ensures success across the applications and business areas affected by the new IT strategy, even before implementation begins. This requires setting up governance teams that represent all stakeholders. Companies that approach this as an afterthought risk duplicating siloes in a cloud environment. Once this cross-functional team is in place, more effective technology decisions can be made to simplify workflows.
IT leaders should adopt the ADRM industry standard4 and invest in master and reference data process teams and foundational technology solutions. To avoid complexity, they can also take advantage of standard connections between systems. This reduces the need for custom integration and overuse of APIs. It makes upgrades and maintenance easier.
Flexibility from the Start with the Cloud
One of the most notable advantages of cloud systems is that they take less time to roll out than traditional software. Where it could take multiple years to implement and migrate all applications in a legacy solution, cloud users can adopt an agile, parallel approach. Or they roll out on an application-by-application basis, dramatically reducing the time required.
AstraZeneca moved to a unified and connected cloud approach in June 2015. This is part of its digital transformation plan. It includes a corporate mission to reduce the time to market for new therapies by a year and a half. Its efforts began in the clinical trials area. It started with an electronic trial master file (eTMF). It also followed with applications for clinical trial management and study startup in 2019. In 2020, the company added solutions for quality. It began its journey to unify regulatory information management and quality all on a single platform.
Results from a Change in Strategy
It is still early in its shift to integrated cloud-based solutions, yet the change in strategy has already produced results. Connecting clinical operations and quality management automated the escalation of data problems, improving reporting and eliminating duplicated efforts. The digital connections eliminated time-consuming processes like manually capturing information on spreadsheets and entering it into a legacy system.
Since the implementation of cloud-based quality applications, AstraZeneca has seen a significant increase in users, the reporting of quality issues, and corrective and preventive actions (CAPA). This has led to increased visibility of quality issues both within and across studies. It also enabled AstraZeneca to achieve a 40% improvement in its corrective action closure rate. This drove improved quality compliance and increased learnings across study teams.
On the clinical side, by 2021, modernization led to an overall benefit saving equating to approximately 100,000 person-hours per year, resulting from an average 50% reduction in the time required to write monitor visit reports. It also achieved a 5% time savings related to issue management across all active sites. The ability to digitally execute processes and manage workflows has allowed AstraZeneca to achieve efficiencies in the operational management of clinical studies.
A Connected Cloud Platform Enables Agility and Speed
As companies work to turn data into intelligence, the cloud can unlock measurable efficiencies. Moreover, these efficiencies include cost savings and increased operational speed. IT leaders and teams should start their cloud implementations with a new perspective that leaves the legacy mindset behind and thinks holistically and cross-functionally. So, this sets a foundation to establish clear governance processes, change management plans, and new connections across teams. Ignoring the bigger picture and a holistic approach can only doom IT leaders and their teams to recreate the same old process and information silos in a new environment.
References
1 “Unified Clinical Operations Survey Report,” Veeva Systems, 2020
2 PhRMA, Biopharmaceutical Research and Development: The Process Behind New Medicine, 2015s.
3 A. Del Miglio et al., “The Case for Cloud in Life Sciences,” a McKinsey White Paper, October 2021.
4 Enterprise Data Models, ADRM Software, 2022.
