How CROs Can Benefit from Continual Improvement Analysis and Benchmarking

As-is analysis is closely aligned with to-be analysis. The former helps an organization assess where it’s currently at, while the latter gives them a future point to reach. Businesses see the value in this type of continual improvement analysis as it allows them to determine what operational and administrative functions perform well and which to forego. 

CROs and pharma companies can also gain much from this approach, along with ensuring proper benchmarking of processes, to achieve and maintain high standards.

In this post, we explore the value that as-is and to-be analysis offers CROs for improving workflow, and also examine benchmarking best practice.

As-Is and To-Be Analysis Explained

Improving how an organization operates depends on identifying any performance gaps. You cannot improve what you cannot see. Gavin Deadman at Intelligent Online says as-is and to-be analysis is effective not only in identifying gaps between the current and desired state, but organizations can also determine how they compare with competitors.

As-is and to-be analyses offer a clear path from starting point and final destination for business improvements.

A Lesson from the 90s: Draw a Map

Way back in 1995, David Carr and Henry Johansson wrote a book called “Best Practice in Reengineering,” based on their research of blue chip companies about how to improve processes to meet targets. 

They point out the usefulness in creating as-is process maps (which they call “Quickmaps”) to assess and depict an organization’s current processes. Within this model, organizations need to be aware of the internal and external connections and boundaries between the processes, and how workflow is affected because of these connections. 

These maps should detail the various units or steps of a process so organizations can look at individual components and how they might be manipulated for heightened performance. 

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Engage Relevant Stakeholders 

Now that we are clear about what as-is and to-be analyses refer to, let’s determine how to conduct those analyses effectively. 

It’s useful to think of an as-is analysis as documenting all of a business’s processes: what they are, how they work, the steps in between and the success and failures, explains Laura Brandenberg, founder of business analyst career training platform Bridging the Gap. 

Essential to curating this list is involving all of the relevant stakeholders. Determine who in an organization — and externally too in certain cases, such as patients involved in research — is affected by or responsible for a process or the steps in it. Then engage them on their role in the process, how they affect it and how it affects them.

Document the As-Is Process 

Once stakeholders are identified, organizations need to determine what is working well in current processes. They can do this through interviews, questionnaires and observation, writes  Nick Greene at workflow software provider Tallyfy. What can also be effective is creating a project team, comprised of either the stakeholders involved in the process or experts in process improvement — or a selection from both groups. 

While it may be tempting to bring in experts, Greene says employees involved in the processes will be the most knowledgeable about the actual operational and practical elements of it. CRO staff members will be well aware of what is working and what’s not in their daily workflow. What’s more, they will likely have ideas about how to improve existing processes. An as-is analysis indicates an organization ready to engage with them to improve company processes.

Cultivate End-to-End Thinking 

A process enterprise refers to a situation in which all relevant stakeholders have an end-to-end view of the process. Core components of this approach include documenting the process, monitoring its performance and governance to deliver continuous improvement, explain Neil Conroy and John Cassimatis at Grant Thornton. 

Organizations can facilitate a culture of end-to-end thinking by training staff to consider the upstream and downstream effects of what they do at their particular point or step of the process. 

Start with a process framework or as-is analysis. Then look at the skills and capabilities in a team, department or organization. Assess the tech and systems in place and ensure they are aligned and integrated. Determine the important processes to improve, and explain to those responsible how their decision-making has an impact on the entire process.

Identifying areas to improve and how to improve them requires an organizational culture that celebrates transparency and evidence. It also requires a commitment to identifying and achieving the most effective and relevant key performance indicators, Conroy and Cassimatis write.

Avoid Common Analysis Mistakes 

Taking stock of processes is important but sometimes organizations make mistakes. Common errors to avoid include over-documenting which happens when too many strengths, weaknesses, opportunities and threats are listed. Over-documenting can lead to unnecessary confusion, explains marketing strategist Laura Lake.

Another error is being too broad and not devoting sufficient detail to the analysis or even incorrectly prioritizing processes or steps within them. Be wary too of including stakeholders’ opinions. Effective analysis depends on facts so should be the main foundation upon which to build the analysis.

Benchmarking Clinical Standards

Improved workflow for CRO and sponsor staff depends on smooth operations of all aspects of clinical research. A key component, therefore, is assessing protocol design through protocol amendment benchmarking, says Mathini Ilancheran at management consultancy Beroe.

“Protocol amendment benchmarking involves characterizing protocol design practices and conducting a root cause analysis on amendment implementation factors impacting study duration cycle times. The trial performance and cost data for all protocols are measured as part of this practice,” she explains.

It’s important to benchmark site selection, study start-up and site activation too. To achieve this, organizations need to look at their KPIs and assess whether current performance matches their goals. 

Benchmarking sites’ performance can determine which one most aligns with the organization’s needs. For example, Ilancheran refers to first-patient-in cycle times, which tend to vary by region. Benchmarking allows CROs and sponsors to make the best decision on a site partner with objective and transparent facts.

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Benchmarking’s Three Main Aims

Benchmarking is an essential tool for improved business performance and strategy. It has three main aims, say experts at Vizient University Health System Consortium. These are to control costs, mitigate risk and improve patient care and satisfaction. 

They argue that organizations can base their benchmarking metrics on standards set by regulatory bodies or agencies, and surpass them to gain a competitive edge. But the process needs to be ongoing as part of a continuous quality improvement plan. 

Core steps in the benchmarking process include: 

  • Choose whether to internally or externally benchmark the process.
  • Identify the key indicators to measure.
  • Validate the data gathered.
  • Identify challenges.
  • Determine and implement changes for improvement.

Benchmarking Needs Data

You can’t evaluate what you can’t measure, so having reliable data against which to compare performance is essential to any successful benchmarking. For instance, having access to a national data set is vital, says Angela Lanning, IT services chief operating officer at Premier. 

Benchmarking focus points should include factors such as costs and quality, workflow and operations, and staff and administrative performance. Lanning says at the research level, benchmarking analytics for objective clinical outcomes analyses requires that health systems, life sciences companies and other stakeholders, build robust relationships to determine how information is tested and shared for improvements. 

Tools to Optimize Workflow

Improving workflow in clinical research generally refers to trials running on schedule, staff performing effectively, tasks being completed on time, resources prioritized and processes made more efficient. But tools are needed to make sure this is done effectively. 

Tools make the collection and analysis of data much faster and more accurate. The quality of that information leads to improved ability to identify problems with workflow inefficiencies as they arise. 

These tools should combine a clinical trial management system, electronic trial master file, electronic data capture, and interactive web response system into a unified, cloud-based platform.

Clinical research software and tools will help facilitate the benchmarking and as-is analysis carried out by a CRO. Of course, these tools are essential to effective management and improvement of processes, given the data capture, tracking and analytics they provide. But the core aspects of benchmarking and as-is analysis require transparency, openness, engagement and communication. 

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