The New Clinical Biometrics Blueprint

The New Clinical Biometrics Blueprint

People, Process, and Technology

Transformation for the Future of Complex and Digital Clinical Trials

Introduction

Key Drivers for Transformation

Transformation: People

Transformation: Processes

Transformation: Technology

In fact, the influence and importance of the biometrics discipline is set to expand in the light of an increasingly data-centric clinical trials landscape. Complex clinical trial designs and a growing volume and variety of data require advanced analytics and flexible data management approaches. At the same time, a pressing need for real-time access to data requires shifts in the technology, skills and processes applied from data acquisition to insight, while patientcentricity and decentralization are also ushering in new ways of designing, managing and analyzing trials.

In light of these challenges, and other industry trends, the biometrics function is in the midst of transformation. In this eBook, we will review the drivers for change, and the focus areas across people, processes and technology that will allow organizations of all sizes, in collaboration with vendors and partners, to achieve success as clinical development continues to evolve.

Data is the critical asset of life sciences, and the biometrics function – shepherding data from acquisition to insight, plays an instrumental role in clinical development success.

Key Drivers for Transformation

Increasing volume and complexity of clinical trial data

Availability of patient-generated data from electronic health records, wearables, and other remote monitoring devices has led to an exponential increase in both data volume and variety. Additionally, personalized medicine, difficulty accessing patient populations in rare diseases, and the need to reflect diversity within clinical trials are driving uptake of innovative trial approaches including adaptive designs, enrichment strategies, and master protocols. Adoption of these designs can improve trial efficiency and patient outcomes, but also lead to increased data complexity, and, in turn, demand new skills and expertise from clinical programmers, clinical data reviewers, data managers, and biostatisticians.

Growing importance of real-time data access and analysis

In today’s speed-driven trials, modern clinical teams increasingly expect real-time, or near real-time data access to detect any issues or trends that may impact the trial outcome and to achieve informed decision-making. Timely data access is also a vital component of facilitating complex trial designs which require ongoing monitoring and planned adaptations. As advancements in technology and data analytics are making it easier to collect, analyse, and share real-time data in clinical trials, biometrics teams are driven to adapt their infrastructure and processes to accommodate this trend.

Increased momentum towards patient-centric trials

The trend towards patient-centricity in clinical trials has significant implications for biometrics functions. Decentralized and hybrid trial models, which aim to ‘meet the patient where they are’ involve the remote collection of real-world data from patients in their homes, and the use of wearable technology and other digital tools. This momentum brings with it a requirement for biometrics teams to manage and analyze large volumes of data from multiple sources, often in real time. The sheer volume of data requires a greater focus on what data is truly ‘critical’ with biometrics teams applying risk-informed approaches, and robust technologies and workflows to manage external data that is collected outside EDC (Electronic Data Capture).

Data scientists also need to think beyond traditional clinical trial endpoints and consider outcomes that reflect the patient’s experience with the disease or treatment. Ensuring participant diversity has also become a pressing priority and data-driven strategies are key to overcoming underrepresentation by providing real-time insights about enrollment.

At the same time, the imperative to give patients with unmet needs faster access to new medicines, is ushering in adoption

of ‘complex’ clinical trials better suited to answering the research question of interest at speed. For example, master protocols, enrichment strategies, and innovative adaptive designs are now commonly used approaches for generating clinical data with greater operational efficiency and reduced patient burden.1

Need for more efficient and costeffective clinical trial processes

Clinical trials require the investment of considerable resources from all stakeholders. As clinical trials become more ambitious, incorporating larger sample sizes, longer trial durations, and more endpoints, the need for efficiency to optimize processes and maximize the chances of overall trial success is heightened.2

Traditional manual processes of data collection, analysis, and reporting are unwieldy and time-consuming. And the consequences of any errors and inefficiencies are severe- leading to costly delays and potential regulatory issues.

By transforming processes to better leverage digital technologies and automation, biometrics functions can accelerate cycle times, maintain regulatory compliance and reduce costs while maximizing the quality and value of critical clinical data.

https://www.efpia.eu/news-events/the-efpia-view/blog-articles/complex-clinical-trials-a-decade-of-innovation-in-clinical-research/ https://www.globenewswire.com/en/news-release/2021/01/12/2157143/0/en/Rising-Protocol-Design-Complexity-Is-Driving-Rapid-Growth-inClinical-Trial-Data-Volume-According-to-Tufts-Center-for-the-Study-of-Drug-Development.html

Transformation: People

The complexity of the current data environment including data source variety, adaptive trial designs, and analytical tools, means that biometrics roles are evolving beyond their traditional scope. With most clinical data now generated outside Electronic Data Capture (EDC), the role of the siloed data manager, focused on cleaning and querying listings of EDC data, is firmly in the past. Instead, data management roles are transforming into technically advanced and influential ‘data stewards’, planning and executing the data strategy and adept at leveraging technologies for data acquisition, organization, management and analysis. Similarly, biostatisticians and statistical and clinical programmers have multifaceted and instrumental parts to play, with the need to align across the biometrics team, and collaborate closely with other clinical stakeholders. This evolution in skills and attributes in turn impacts on how organizations must approach recruitment, retention and training.

Talent attraction and retention

As the demand for specialized skills and experience increases, sponsors must be strategic in their recruitment efforts to succeed in a highly competitive, candidateled market. In addition to traditional recruiting channels, organizations can use social media and professional networking sites to connect with potential candidates. They can also partner with specialized recruiting firms that have experience and established networks in the biometrics field to find top talent. Specialist biometrics services providers help sponsors to access hard-to-hire talent and expertise through tailored FSP (Functional Service Provider) outsourcing models.

With new roles and responsibilities emerging, many biometrics leaders are reassessing their hiring criteria and job descriptions to attract candidates with the desired skill sets. For example, as the demand for data science, advanced analytics and machine learning expertise increases, organizations may need to broaden their scope to include candidates with broader quantitative backgrounds.

Alongside these considerations, soft skills, and the ability to leverage technology are becoming more highly emphasized and sought-after characteristics. By taking a strategic approach to talent acquisition and investing in building a diverse and skilled workforce organizations can position themselves to navigate the rapidly evolving biometrics landscape.

Retention is also a key area of focus. A culture of professional development shows a commitment to employees’ growth and development leading to increased job satisfaction and retention. Equipping staff with the skills they need to adapt to the changing landscape helps to maximize retention and minimize the institutional knowledge loss associated with turnover. At eClinical Solutions, we have been able to achieve high levels of biometrics staff retention through holistic training initiatives and giving team members the freedom to pursue strategic, innovative work alongside operational delivery.

Read our Industry Outlook 2023 to learn how your peers are responding to clinical data trends, challenges, and opportunities.

Training

With the breadth of skills required spanning technical, technology and soft skills, developing a strong biometrics team in this new environment requires targeted and customized training programs that focus on the specific requirements of the evolving roles. For example, statistical programmers will increasingly draw on programming languages beyond SAS, such as R, alongside the development of new skills in machine learning and artificial intelligence. For biostatisticians, exposure to adaptive trial designs and Bayesian methods is important. In addition to technical training, soft skills such as project management, communication, and leadership are increasingly important in a modern biometrics environment which relies on collaboration between multiple internal and external stakeholders to succeed.

Building a culture of innovation and collaboration

eClinical Solutions’ Industry Outlook 2023, uncovered that one of the frustrations that clinical leaders experience with their service providers is a lack of innovation. With the fast pace of change, it’s important to be intentional about creating a culture of innovation to drive progress and support the adoption of new technologies.

To achieve this innovation-led culture, biometrics leaders can encourage their team members to be curious, experiment, and think creatively. Opportunities for professional development and training, cross-functional collaboration, and a transparent communication environment all contribute to a more forward-thinking, receptive environment where new ways of working can thrive.

Leveraging external partnerships and collaborations for specialized expertise

Many biometrics functions rely on external partnerships and outsourcing to manage capacity, increase efficiency, and access specialist expertise. Increasingly, with the data environment becoming ever more involved, demanding deep expertise, organizations are choosing specialized, data-focused outsourcing partnerships to handle their data management, biostatistics and statistical programming work, rather than a ‘full-service’ outsourcing approach. By working together with specialized partners, biopharmaceutical sponsors can optimize their biometrics infrastructure and successfully navigate the complexities of digital and complex clinical trials.

Regardless of the type of partnership chosen, it is important for pharmaceutical sponsors to carefully consider the capabilities and technologies of their partner organizations and ensure that their goals are aligned. Effective partnerships are built on a foundation of collaboration, communication, and trust, providing clear roles and responsibilities for each partner, with a robust governance structure and oversight capabilities.

Transformation: Processes

Harnessing automation

According to the eClinical Solutions’ Industry Outlook 2023, harnessing automation throughout the clinical data life cycle was the top industry focus for more than one-third (36%) of respondents. Across the data life cycle, from acquisition to insight, there are multiple applications where automation can streamline routine tasks. For example, at eClinical Solutions, our teams are applying automation to create efficiencies within database build, and automation and machine learning approaches to complement manual data cleaning. Organizations can also leverage automation to support data integration and statistical analysis tasks, leading to higher data quality and efficiency. As biometrics leaders incorporate automation into their processes, they should focus on developing their team’s skills, while prioritizing the selection and implementation of tools that align with the organization’s goals and integrate well into existing workflows.

Incorporating risk-informed approaches

Against the backdrop of trial complexity, incorporating risk-based approaches enables biometrics teams to focus their resources on the most critical data, ensure overall quality, patient safety and comply with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and

regulatory guidance. As well as meeting these requirements from regulatory agencies to use effective risk management practices, there is growing recognition of the value of risk-based approaches in improving efficiency and cost-effectiveness of clinical trial operations while reducing the burden on teams. Incorporating RBQM (risk-based quality management) typically involves adopting new technology platforms, as well as developing standard operating procedures (SOPs) and upskilling staff on RBQM practices. Leaders can practice a stepwise approach to adoption by leveraging an RBQM solution that is integrated with a clinical data platform, or ‘starting small’ with pilot studies, a single process, or adopting ‘out of the box’ solutions such as standard KRIs across their studies while refining an overall RBQM strategy.3

https://www.eclinicalsol.com/webinars/overcoming-barriers-to-rbqm-adoption/

Establishing external data processes

In the context of extensive data collection outside EDC, processes and technologies to manage external data are essential tools of biometrics delivery. In recognition of this importance, at eClinical Solutions, our Biometrics Services team has established a Center of Excellence for External Data to drive best practices and create efficiencies through standardization, while leveraging elluminate. As biometrics functions evolve, alongside implementing technologies to handle large volumes of data from multiple sources, they can focus on best practices, relationship management and standardization initiatives. For example, engaging closely with external data vendors to assess their data quality and reliability, establishing strong communication and relationships, and implementing standardized Data Transfer Agreements (DTAs) are all practical steps. For effective external data management, organizations may also set up systems for tracking KPIs (Key Performance Indicators) such as data quality, accuracy, and timeliness and use technologies to enable visibility.

Ecosystem for decentralized trials

Decentralized trials (DCT) offer significant benefits for trial recruitment, retention, and operations, however, there are challenges for sponsors with adoption, developing capabilities, and handling data complexities. As uptake of decentralized trials increases, biometrics teams will need to consider and address any gaps in their technology stack and capabilities such as specialized DCT platforms, DCT- enabled analytics, and biometrics outsourcing services with DCT-trained professionals. With change management top of mind, leaders should ensure that team members have the necessary skills and training to effectively utilize these technologies and navigate the rapidly growing vendor ecosystem.

Transformation: Technology

As discussed above, many organizations are choosing to build specialized, data-focused outsourcing partnerships to handle their data management, biostatistics, and statistical programming work, rather than choosing a ‘full-service approach’. Alongside harnessing these specialized partnerships to drive biometrics transformation, organizations can also build efficiencies by leveraging the technology stack and technology knowledge of outsourced partners.

Implementing a data and analytics infrastructure to drive faster insights

In the light of the industry drivers discussed, organizations face an increasingly urgent need for a data ecosystem that ensures data quality and enables insights throughout the trial lifecycle. Leveraging a data management and analytics platform that centralizes trial data from all sources –such as the elluminate Clinical Data Cloudis an approach that addresses these challenges. With a platform approach, data silos are eliminated, manual work is reduced, and costly downstream errors are avoided. The benefits are multi-fold, including more efficient data-driven decision making, increased productivity, and accelerated cycle timelines.

Learn

Combining biometrics services with technology can streamline both technology adoption and biometrics delivery, saving time and effort for the internal team and maximizing the return on investment. One example of successfully combining biometrics services with technology is illustrated by a recent client story which highlights how combining biometrics services and elluminate resulted in an ingenious solution for a top 20 pharmaceutical client, allowing them to effectively handle eSource workflows within a Phase 1 trial, and support fast-turnaround data review for dose escalation.

more about how Biometrics Services and elluminate transformed Phase 1 workflows for a top-20 client

Leveraging an Integrated Statistical Computing Environment (SCE) to Accelerate Statistical Analyses

For organizations that do not yet have a statistical computing environment, managing statistical analyses is all too often a manual, disjointed process. With the increasing amount of clinical data available, more sophisticated methods, and an emergence of data science techniques, a high-performance computing environment is necessary to produce accurate and consistent results while maintaining traceability. Modern SCEs are an integral cornerstone of a forward-looking biometrics strategy within a digital age, increasing development efficiency and streamlining program execution.

For statistics and programming services providers, technology that eases ongoing statistical review rather than traditional milestone-based review processes enables greater proactivity and accelerates speed of analysis. Tools that enable standardization and automation are also key when it comes to submission-related activities such as ISS/ISE (Integrated Summary of Safety and Integrated Summary of Effectiveness) and DSURs (Development Safety Update Reports).

Aligning Service Providers and Technology Providers

Working with a service provider who has adopted the same technologies offers several advantages in terms of streamlined processes, reduced errors and inconsistencies, and improved communication and collaboration. By working together with a common technology stack, the provider and sponsor can work together more seamlessly, with common tools and workflows aligned against common objectives. The results of these synergies include improved efficiency, reduced costs, and improved quality and reliability of clinical trial data. Similarly, leveraging biometrics providers’ technology infrastructure frees up the sponsor organization to focus on their core competencies and priorities.

Conclusion

The trends discussed within this eBook will continue to shape the clinical development landscape, with ongoing demand for faster insights, widespread decentralization and patient-centric trials, alongside rapid advances in analytical capabilities.

About eClinical Solutions

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert biometrics services and the elluminate® Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and eClinical Biometrics Services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Leveraged by 100+ biopharmaceutical companies, elluminate is a purpose-built clinical data cloud designed to accelerate digitization efforts that proactively manage the exponential growth of clinical data volume, variety, and velocity.

eClinical’s Biometrics Services combine top talent with best-in-class technologies, rigorous processes and the power of elluminate, to deliver efficient, high-quality clinical data solutions fit for the new era of digital trials. From acquisition to submission, we enable sponsors to execute an end-to-end data strategy that embeds standardization and streamlines oversight. Whether partnering with us for study-based biometrics services, functional service outsourcing, or specialized clinical data consultancy, sponsors of all sizes rely on eClinical Solutions for agile, expert support with the right skills and technology for today’s speed-driven, complex trials.

In this context, it is a critical strategic imperative for leaders to build a biometrics function which is equally robust and adaptable to collect, manage and analyze the vast amounts of data while ensuring accuracy, efficiency, and regulatory compliance.

In both the current and future state, organizations that can more effectively leverage their data will be better positioned to make informed decisions, optimize trial designs, and bring innovative new therapies to market faster.