AUTHORS: SOPHIE HENDERSON, CUSTOMER SUCCESS DIRECTOR & NICK BORDERS, SENIOR DIRECTOR OF BUSINESS DEVELOPMENT
Today, many clinical trial organizations realize the great benefits of Risk-Based Quality Management (RBQM). However, some are still facing challenges in identifying an approach to best implement RBQM in their overall clinical trial strategy.
There is a lot to think about, from setting the right objectives to making sure you have the right people, processes, and technology in place. Here, Sophie Henderson, Customer Success Director and Nick Borders, Senior Business Development Director, talk us through the ten most important considerations for a small biotech about to embark on an RBQM journey.
1. Foundations: Define your objectives and set your definitions.
Successful RBQM projects need a strong foundation, so organizations need to do the focused work amongst their various stakeholders to understand what they are setting out to achieve.
Vague aims like “improving data quality” will limit your ability to proactively measure progress and take any necessary course-correcting action. Nevertheless, they’re a solid starting point, and a little further interrogation will get you to a more concrete goal. Definitive, quantifiable objectives – that have the full backing of all those involved – are the secret to success.
Before embarking on their journey, multi-functional teams must think about what they want to achieve, whether increasing the speed of submission or decreasing inspection readiness timelines and how they will measure it.
Be sure to include your development partners in these discussions so that everyone is on the same page and working towards the same goal throughout the project.
2. People: Identify your executive sponsor, trusted advisor, and champion.
Getting the right people in place is the next step – and these three roles are the starting point.
A good executive sponsor will be a senior executive who understands the importance of risk-based approaches and agrees to support the RBQM team to meet their goals.
Trusted advisors help shape internal processes and act as mentors to less experienced members of the RBQM team. It’s a hands-on role, so smaller biotech companies outsource it to a CRO, consultant, or technology partner.
RBQM champions are important as they work across the organization to grease the wheels of change management. The ideal candidates will have excellent communication skills, be well respected by their peers, and excel at motivating and rallying teams.
Lastly, the identification of three individual leaders isn’t necessarily required. One person may be perfectly capable of assuming multiple roles.
3. People: The cross-functional team is key.
Of course, ownership of an RBQM initiative will often sit with one department within the biotech but building a cross-functional team with 360° oversight is crucial. The cross-functional team usually comprises a sponsor, CRO, and sometimes RBQM technology provider members for small companies.
A team that includes representatives from all stakeholders – for example, medical/safety, study management, site management, data management, biostatistics, quality, and development partners – will be better able to understand centrally identified risks, conduct root cause analyses, and take immediate action.
4. People: Train your RBQM team on data literacy upfront.
Once the team is defined, it’s time to prepare them for the task. Step one is making sure they are data literate or able to understand, interpret, and communicate with the data.
They also need to understand where the data originates, which data sources first capture it, and when multiple data sources exist, which is the master, and which is the slave.
5. Processes: Focus on what matters most.
Once the people are in place, it’s time to turn to the processes. Again, there’s a lot to consider, so to avoid being overwhelmed, focus on what matters most.
Our top tip is to continually build the process with the goal in mind. This will ensure it aligns with the overall objectives identified in step one. Also, avoid duplication of effort by exploring and confirming any preexisting RBQM activities and clearly defining who does what and when.
Central monitoring activities inevitably flag occasional anomalies that don’t require immediate mitigation and control. Keep the RBQM team focused on what matters most by defining a process that includes the questions and decision points needed to determine between acceptable risks and those critical to quality.
What’s more, if your CRO is responsible for central monitoring activities, make sure you take a seat at the table to secure oversight over your study, now insisted and mandated in several regulatory guidance documents.
6. Processes: Never underestimate the importance of risk assessment.
Risk assessment is the foundation of the RBQM framework because it develops the plan to mitigate, eliminate, and accept risks. It facilitates the identification of critical quality factors and should never be underestimated.
During the study design phase, principles of Quality by Design challenge sponsors to evaluate risks to patient- and site-centricity and overall operational success. Ideally, Risk Assessment should be a continuous process, starting as the protocol synopsis becomes available and continuing through the planning and execution of the trial.
The exercise may be in-house or outsourced, depending on the biotech’s internal resources. Whichever route you choose, make sure team members with portfolio-wide knowledge and sponsor representatives are involved so that all relevant risks, lessons, or concerns can be raised.
7. Processes: Developing a RACI (Responsible, Accountable, Consulted & Informed) Model.
As a small company, you may have limited internal resources and rely on external support. To avoid gaps or overlap, thoroughly define internal and external roles and responsibilities. A clear RACI will ensure success.
Additionally, there’s plenty of help out there. Look for industry guidelines and whitepapers and draw on your development partners’ experience to help define thresholds, indication specific KRIs (Key Risk Indicators), and what constitutes critical.
8. Processes: Make sure you have the data.
Always make sure you have data transfer agreements, which give you access to the data at a frequency that aligns with your central monitoring plans.
This may sound obvious, but failure can lead to delays, especially if the data management development partner is not responsible for the Central Monitoring activities.
9. Technology: Quality Cost Timeline Triangle.
Achieving faster time to market is critical for small biotech’s and relies on both careful budget allocation and high-quality data.
Triple constraint theory would tell you that cost or timeline reductions will constrain the quality of your trial unless its scope is reduced accordingly. Implementing RBQM with the support of the right technology partner can help you break this model, impacting all three of these dimensions to help you reduce cost, bring in timelines, and improve data quality.
10. Technology: Select the right technology partner.
Again, this sounds obvious, but it can be challenging to know where to start when looking for a technology partner.
Our advice is to identify a comprehensive and configurable solution that provides the necessary functionality to support your defined outcomes. Moreover, try to avoid technologies that require delaying extensive build and management.
For small organizations with limited data and experiences, machine learning (ML) and deep learning capabilities offer a bonus. The ML-driven ‘signal grouping’ and ‘root cause consideration support’ in CluePoints’ solutions, for example, assess past decision-making information to automate processes for the end-user, simplifying the process and ensuring that you always focus on what matters most and how to mitigate risks quickly and efficiently.
