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!
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:
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
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.