Focus On These 4 Things To Accelerate Clin Ops Productivity

Whether your clinical operations team sits in a large sponsor company, or in one that’s still growing, it must be supported by efficient systems to maintain high productivity.   

Clinical trial protocols must be conducted with quality, within budget, and within timelines.  To achieve this, Clinical Program Managers and their teams must be able to rely on 4 things:

1. A strong organization (i.e. people and teams)
2. Access to accurate data/insights for clinical trial oversight
3. Innovative support tools specifically designed for clinical operations teams
4. Efficient processes

Ignoring any of these elements can significantly reduce productivity and potentially increase costs. When productivity falls and trial timelines start slipping, Team Leads are encouraged to analyze these elements and urgently apply corrective steps where needed.  But too often, traditionally minded managers have a preconceived notion that the problem lies with their people (i.e. the “organization” component) and that restructuring or “throwing more bodies at the problem” is the solution.  This approach isn’t just misguided, it can be inefficient and costly. Per this HBR article, expert management consultants report that 94% of most problems and possibilities for improvement belong to the system, not the individual.  The remaining 3 elements, therefore, are equally critical for ensuring high productivity.  However, they are frequently neglected.

Let’s review each of these 4 elements and how they contribute to clinical operations productivity.

• Organization – Organizational psychologist Edgar Schein recommends that team members understand how their individual roles contribute to the whole.
  • When qualified candidates are identified and selected, a smooth, clear, and thorough onboarding process is the essential next step.
  • Division of labor, communication paths, and decision-making authority among team members must be clearly communicated and often.
  • This will ensure that the right people are doing the right things at the right time, and enables teams across the entire organization to make timely decision within their scope.


• Data – Data that facilitates clinical trial oversight ensures trial conduct, decision making and risk identification that is more data-driven.
  • Failing this, sponsor companies risk huge financial consequences from slow, inefficient, and inaccurately conducted trials.


• Tools – Clinical Program Managers and VPs should examine the types of technology systems they implement to support their teams (outside of the usual EDC, IXRS, etc.).  A “clinical trial oversight” system should have
  • Automation and data imports from other systems to lower total workload for clinical operations teams
  • Multiple functionalities and collaboration tools to reduce workflow complexities.  This helps to reduce the cognitive overhead and stress of context switching.
  • Built-in processes that sit neatly into existing standard clinical trial activities, eliminating the need to design these processes form scratch (see “Processes” component below).  Poorly designed systems require the creation of extra process/workarounds that only exist to allow the use of those systems.


• Processes – Clinical operations relies on a framework of processes that ensures the smooth conduct of trial protocols by internal and external stakeholders.
  • Designing uncomplicated, repeatable workflows is the final step to ensure a super productive clin ops team.
  • Creating SOPs, onboarding, and training documents will quickly help team members acclimate to the organization, teams, and trials to which they’ll contribute.
    • These should outline the who/what/how that are essential for their roles.
  • Carefully designed processes and workflows bridge the gap between the organization – its people – the data, and the tools used to do daily tasks

ClinOps Pro is the Clinical Operations Oversight Solution that was designed to work neatly within the 4 elements above, and is the ideal tool to boost clinical operations productivity.

Accelerating, then maintaining clinical operations productivity doesn’t need to be complicated.  With the right supporting technology, your organization can experience simplicity and clarity while meeting (or exceeding!) trial deadlines and staying within budget.

Sources

• https://hbr.org/2021/01/productivity-is-about-your-systems-not-your-people?utm_source=pocket-newtab
• https://courses.lumenlearning.com/boundless-business/chapter/components-of-an-organization/