Standard Operating Procedures (SOPs) are a “Fit-for-Use” structured data build reflecting processes, typically used as a tool to deliver internal excellence. Though SOPs are internal process documents, they are the essential documents that the Food & Drug Administration (FDA) is interested in during an audit. The list of SOPs shared is used to understand the governing principles and process of the department. In Clinical  Life Science research, knowledge as an SOP is not always available in a ready to use format; so in this case, SOPs may sometimes be a structured knowledge base built using unstructured reference data.

In this article, I envision Project Knowledge Management and SOPs as a perception shift from narrowly fulfilling compliance to a broader compilation of knowledge by subject matter experts. In this shift, the SOP becomes a refining process which supports excellence. Excellence not only in writing, but in representing the knowledge of a subject matter expert (SME). A SME in problem solving, dynamic learning, strategic planning, decision making, etc. This shift in strategic thinking provides broader support of the mission and vision of the organization.

The knowledge enablers for a classic clinical SOP are: Standard FDA guidance documents regarding current thinking on conduct of trials (guidance documents are non-binding and a recommendation), and reference platforms such as https://clinicaltrials.gov and ICH guidelines to name a few.

In pharma and biotech, with increased hybrid roles during the pandemic, many operational and functional teams had to get creative to enable business continuity. Since then, working practice guidelines have evolved. Many organizations have adapted agile methodologies in search of higher productivity, to facilitate innovation and bridge the gap between academic suggestion and real-life scenario.

This interest in agile methodologies has pushed for new working models. Clinical Operations is now more open to incorporation of an agile-waterfall framework. For example, in clinical trial operations, work from home was a rare instance. This changed greatly during the pandemic when employees were forced in many cases to exclusively work from home. And, now as companies transition to hybrid work from home models, this has pushed for knowledge beyond lessons learned to get the information right. The goal of hybrid communication is to incorporate tacit and explicit knowledge and embrace a project approach for knowledge management.

This project approach for knowledge management is a sustained improvement that incorporates shared goals, interest, confidence and brainstorming, to convert SOPs into an enhanced change initiative management tool.

Live online project management platforms like Asana and Trello have proved to be extremely useful for knowledge collection in the hybrid work environment. These platforms have allowed for inclusion of information irrespective of geographic location of the work, but also have enabled teams to have enhanced awareness of and power to remove jargons and short forms, consequently developing extractable working knowledge.

This extractable knowledge now governs identification and solution of day-to-day drug development challenges. Although the date of extractable knowledge and revisions are documented in the project template, it is yet to be determined if this knowledge can be used for building internal SOPs.

As Project Managers using agile methodology in Pharma and Biotech, we can ask ourselves two key questions:

1. Does using a tool such as Trello, Asana etc., as a shared knowledge platform allow for higher productivity and real-time implementation of learnings, without having to find relative SOPs in yet another system?
2. Is a project template housed in these live project management tools delivering the right outcomes at the right time yet to be determined?

Shifting the perception of SOPs from just a compliance document housed in a document storage system to living documents containing collective human achievement allows Project Managers and Teams to own their learnings and become subject matter experts.

References:
Clinical Trials Guidance Documents | FDA
Clinical Research Study Investigator's Toolbox | Guidance Portal (hhs.gov)
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Freedom of Information Act, Revised, 2000. 4. Plain Writing Act of 2010.