Automation of Standard Operating Procedures (SOP) Streamlines Clinical Trials

Using e-signatures to expedite transactions is one of the surest ways to generate immediate efficiencies within clinical trials. In fact, Sarah Cannon Research Institute, one of the largest clinical research organizations in the world, sped up its highly regulated signing process by up to 94 percent by using SIGNiX’s Independent E-Signatures™, and it expects to save $250,000 in its first year to boot!

Even when using e-signatures, opportunities exist to streamline processes even further, which ultimately saves time and money and can get important clinical therapies to patients sooner. 

Guest blogger Craig Morgan, of goBalto, weighs in on another way organizations involved in Clinical Trials can harness the power of efficiency to streamline processes.

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Standard Operating Procedures (SOP) are one of the most useful systems to help improve the efficiency of clinical trials, which can aptly be described as “writing down what you do, and do what is written down.” They are a set of instructions with the force of a directive that standardizes a procedure or specific function and act as an effective catalyst to drive performance improvement and organizational results.

Clinical research SOPs are an important way to help sponsors and CROs follow Good Clinical Practices (GCPs), as published by the International Conference on Harmonization (ICH), considered the authority on clinical theory and principles.

Interestingly, SOPs are not specifically mentioned in FDA regulations, however, there is guidance and regulations that infer responsibility and SOPs formalize investigator responsibilities (21 CFR312.53). Additionally, SOPs are mentioned repeatedly in ICH GCP Guidelines (ICH GCP 2.13).

The importance of SOPs cannot be overstated in clinical trials. Specifically, they:

• Manage compliance obligations: SOPs ensure that all research conducted as part of the clinical trial follows federal regulations, ICH GCP, and institutional policies.
• Create operational efficiency: SOPs ensure processes have been examined and optimized. They standardize common processes amongst all studies.
• Reduce learning curve/training of staff: SOPs are a lifeline to new employees, detailing how activities are required to be performed, they act as a resource to keep everyone on the same page at all times.
• Ensure business continuity: SOPs allow for continued operations in the event that a key staff member is unavailable. By referring to the SOP someone can handle an urgent task and do it correctly the first time.
• Quality control: SOPs help reduce errors, or variations. They improve the quality of the data collected, thereby improving the science of the study.

The benefits of SOPs are clear – they provide a level of formal accountability for team members, and they prevent noncompliance on a systemic level.

But…they can’t help you if you don’t use them.

The major limitation of SOPs is noncompliance, or worse still, avoidance. How can you automate a SOP for document exchange to ensure the proper flow of documentation – the right document, to the right person(s), at the right time? What about signing protocol?

From an oversight perspective the complexity is self-evident as studies on average have 82 sites per study (source: TTC, llc: Annual State of Clinical Development Costs) – How are all these country specific documents tracked? Where are we in the process? Where are the bottlenecks and inefficiencies? Who has access? Are we in compliance with our institutional SOPs? 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.

Role based document exchange facilitates efficient process optimization. Role assignment embraces a 1:M (any) paradigm. Study startup at the outset of clinical trails is plagued by bottlenecks, which slow drug development. It is a global endeavor fraught with delays and countless country requirements, traditional manual processes (e.g., Excel, courier, email) are often handled via sole assignments, which inherently results in delays of document exchange/routing due to the assigned person being on vacation, sick, or generally unavailable…or quickly becoming the ‘norm’, simply being too overwhelmed with other activities to respond in a timely manner. Role assignment allows multiple people – with the same authorization and training – to carry out the activities required to keep the clinical trial on-track. It also ensures that only those eyes have access to the documents that pertain to them.

With the advent of intelligent document routing technology sponsors, CROs now have the ability to support country-specific document regulatory workflows, facilitating handoffs – globally, utilizing alerts, document collection, version control, status reporting, thereby eliminating the number of handoffs, errors and downtime events that typically occur throughout the start-up phase of clinical trials providing efficiencies in critical path management and SOP design.

A study startup solution is the missing piece of the eClinical jigsaw that guides sponsors and CROs through clinical study startup – supporting country-specific document regulatory workflows and serves as the repository for in-progress documents. The use of a study startup tool allows for the seamless sharing and visibility of documents and associated information in real-time – globally – facilitating handoffs.

See how you can accelerate your clinical trials – request a free demonstration today to learn more http://www.gobalto.com/demo-request.

About the Author

Craig Morgan is a technology and life sciences management professional with more than 15 years experience in the application of informatics and bioinformatics to drug discovery. He currently heads up the marketing and brand development functions at goBalto, working with sponsors, CROs and sites to reduce cycle times and improve collaboration and oversight in clinical trials.

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