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October 11, 2022

Clinical operations: why is it important?

The impact of clinical operations in the drug development lifecycle and what tools can streamline the process while maintaining compliance.
clinical operations

Article updated June 2023.

What is clinical operations? Clinical operations, or clin-ops, ensure patients receive the highest quality care. Beyond that, the clinical operation definition also encompasses adherence to regulatory requirements and standards.

According to Zippia data, more than 23,000 clinical operations managers are employed in the United States alone. While these professionals and everyone on their team are at the heart of clinical trial success, it’s not always easy to understand this function within a healthcare organization.

This post will explore what you need to know about clinical ops and why they matter. The topics we’ll cover include:

  • Why is clinical operations important?
  • Common activities and responsibilities in clinical ops
  • Three trends impacting clin-ops
  • What tools can ensure success in clinical operations?

Drive engagement that maximizes patient retention and investigator satisfaction.

Why is clinical operations important?

Clinical operations are a crucial part of the healthcare industry because they ensure that the services a healthcare organization provides are effective. The ops department works to establish that all clinical staff and patients have what they need to work together well and see that the process is smooth.

Specifically, these teams can come into play during the drug development lifecycle. Once discovery and preclinical research are complete, the clinical development process begins. This step is where clinical trials and volunteer studies occur to ensure the drug is safe for human use. Clinops play a vital role in making sure those trials are a success.

It’s important to note that clinical operations is distinct from clinical development. To understand more about clinical development vs clinical operations, read a client case study about clinical trial design.

Common activities and responsibilities in clin-ops

What does clinical operations do? In the healthcare industry, many activities or operations fall under this team’s responsibility. These include:

  • Patient flow: How patients are moved through a clinical trial.
  • Patient safety: Ensure all clinical staff follow safety protocols and policies to prevent patient harm.
  • Quality assurance (QA): Monitoring patient care to ensure it meets regulatory agencies’ standards. QA tools include chart audits, clinical peer review programs, and quality improvement teams.

Beyond those specific activities, any clinical operations team needs to pay attention to what’s trending in healthcare and how those trends will impact processes moving forward.

Three trends impacting clin-ops

What trends do organizations need to be aware of to better support the patient journey and have more successful trials? Here’s a look at some of them:

Changes in technology and delivery of care

Data growth and the expansion of technology are making a mark on all industries, and healthcare is no exception. In fact, with an expected compound annual growth rate (CAGR) of almost 25 percent from 2019 to 2025, the digital health industry should reach nearly US$660 billion. Organizations need to understand how this is changing the clinical trial process. It’s also a chance to discover new ways to leverage all the data that life sciences professionals can now gain access to.

Increasing decentralization

The benefits of decentralized clinical trials became apparent during the pandemic, and they will likely stay here. Taking this approach may help pharmaceutical companies get the information they need better and faster, but for that to be the case, clin-ops have to have processes in place to keep up. Other innovations in the clinical trial arena include hybrid trials and digital trials. While the benefits of hybrid clinical trials closely mirror those of decentralized trials, they are structured slightly differently. The impact of digital clinical trials includes more accessibility to patients who previously could not participate and benefits such as accurate and complete data collection.

Impact on the patient experience

Patients want to have more involvement in their healthcare and expect their voices to be heard. This is excellent news in clinical trials, as people are more interested in engaging. However, they also don’t want to struggle to communicate their ideas and experiences. Time and effort must go into improving the clinical trial experience from start to finish. Despite the challenges in decentralized health care, patients stand to benefit from a health system that affords them more choices.

Watch “The Roadmap to Virtual Engagement in Clinical Operations”


What tools can ensure success in clinical operations?

Many different clinical operations tools help ensure various aspects of success in clinical operations, including compliance, increased patient retention, and investigator satisfaction. You should be aware of these:

  • Electronic health record (EHR) systems can support clinical decision support, population management, and other functions in real time
  • Credentialing and access tools ensure that information only goes to the eyes (and minds) of those who should have it
  • HIPAA compliance processes or software to keep organizations in line with those requirements throughout the entire trial process
  • Insights management technology, including asynchronous engagement and artificial intelligence that helps teams identify trends or areas of concern

Depending on your specific healthcare or pharma organization’s operations, you may leverage other tools. While the most critical aspect is being able to identify and mitigate compliance issues, patient retention is also an essential element to successful trials.

Bottom line: Leveling up your clinical organization

Within3’s insights management platform delivers seamless collaboration and communication for clinical development and operations teams. Sponsors engage sites, patients, and payers to improve clinical study design, training, and trial execution. Read how the platform works for clinical trial design teams, or learn more about insights management in our blog series.

Zippia. Clinical Operations Manager Jobs Demographics.
CK Group. A Guide To Clinical Operations.
Statista. Global Digital Health Market Size Forecast.

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