Bottlenecks can have punishing consequences on clinical trials and operational teams, forcing studies to get stuck in limbo when the delay lingers — and when bottlenecks become the norm, team members can grow frustrated and overloaded with a cascade of sudden tasks, potentially creating a resource and morale issue. Bottlenecks are particularly problematic for CROs as they can take a bite out of return on investment and raise oversight inquiries from sponsors. Sometimes, that stems from budget-busting overtime when teams move from idling into working long hours once the bottleneck breaks.

SOPs help to spot bottlenecks — or more aptly the automation of SOPs — by mapping out workflows to aid in identifying congestion, with associated cycle-time metrics. Specifically, automating SOPs for study startup, a notorious bottleneck, can guide sponsors and CROs to compliance using workflows consistent with organizational standards and country-specific regulations. SOPs have long been fundamental to many industries, and the clinical trials sector is no exception.

SOPs are one of the most useful systems in helping to improve the quality and efficiency of clinical trial execution by allowing clinical project managers a way to spot and bust through bottlenecks before they put the trial in jeopardy. SOPs are therefore key to risk management strategies and a deterrent against the dreaded rescue study. SOPs help standardize a procedure or specific function and aid sponsors and CROs to follow good clinical practice guidelines, as published by the International Council on Harmonization.

The benefits of SOPs are clear, they provide a level of formal accountability for team members and they prevent noncompliance on a systemic level. Specifically, SOPs ensure compliance with all regulations, create operational efficiencies by ensuring processes have been standardized and optimized across studies, reduce training timelines for employees, ensure business continuity in the event of staff turnover or unavailability and improve quality control by helping to reduce errors or variations.

Regulations require that SOPs be utilized and that, ultimately, clear documentation exists that demonstrates the processes were followed. Yet, too often, they are ignored or even avoided. Failure to keep accurate records and establish and maintain SOPs appear frequently in Form 483 violations and warning letters issued by the FDA — but how can an organization enforce SOP compliance?

The complexity of ensuring compliance is self-evident. How are all country-specific documents tracked? Where are we in the process? Where are the bottlenecks and inefficiencies? Furthermore, ensuring that the most recent versions of these documents are used can be challenging, if not a daunting task, especially if there are multiple versions and amendments across multiple countries.

With the advent of intelligent document-routing technology, stakeholders have the ability to support country-specific regulatory and organization-specific workflows — essentially acting as a virtual assistant to guide team members through the process as the clinical trial unfolds. Authorized team members can view and manage existing configurations and then edit them to create the settings needed for tracking documents, submissions and milestones. Automated workflows facilitate and track document collection and handoffs across the globe, and provide version control, status reporting and role-based assignments to ensure appropriate access. Additionally, alerts notify study team members when prerequisite work has been completed and what’s waiting for them in their queue. These notifications help decisionmakers intervene immediately, before a major setback has occurred, instead of after the fact.

With the availability of workflow-based study startup tools, proactive planning, process optimization and quality improvements with study startup — as measured by inspection readiness and the likelihood of passing regulatory audits — are within reach.

Proactive planning requires sponsors and CROs to identify the risks up front, as well as the study requirements, prior to activation. Failure to do so results in problems not being identified until much later, often in advance of an inspection and well after completed documents, artifacts and metadata have been released to the trial master file. A better strategy is to employ processes that take an upfront approach to preventing or mitigating problems associated with study startup document completion.

Using a workflow-based approach, critical indicators of quality can be accessed on an ongoing basis so that corrective actions can be made earlier (e.g., inaccurate study indexing, missing documents — such as a missing medical license if you have CV for an investigator — missing document completion date, etc.).

Historically, regulations have not provided specific guidance on the format or content of SOPs, allowing sponsors and CROs to design SOPs that best conform to their unique practices. But the long history of SOPs being confusing, overly complex or existing only in paper format has led to their less than consistent use, even avoidance.

Automated workflows breathe life into SOP compliance and adherence to clinical timelines and budgets while improving quality and boosting operational efficiencies. It’s this consistency that breeds speed, as it’s often deviations that create bottlenecks to begin with.

These integrated workflows based on SOPs represent the unsexy plumbing of clinical trials, which rarely grabs the spotlight like transformational technologies or newer strategies, such as quality by design or decentralized clinical trials — nevertheless, they deserve recognition for their ability to aid in compliance, risk management, quality and overall operational efficiency efforts. After all, if you fail to plan you are planning to fail.

Morgan (craig.d.morgan@oracle.com) is responsible for directing the global marketing strategy and team for the Oracle Health Sciences suite of study startup applications. He is a technology and life sciences management professional with more than 15 years’ experience in the application of informatics and bioinformatics to drug discovery, and eClinical technology associated with starting clinical trials.