Using SharePoint to Centralize and Automate Key Business Processes in a Clinical Research Organization

Microsoft SharePoint has been around for many years now and has become something of a staple in the organizational pantry that gets continually pushed to back in favor or newer, flashier applications.  The reality is that this is probably one of the most powerful tools yet underutilized tool in your portfolio for helping to automate your manual business processes and provide visibility into critical business data. Over the last decade, I have worked within a variety of industries to help clients set up and efficiently utilize their SharePoint sites and seen many successes but nowhere has this been more visible than within the Clinical Research space.

Opportunity

The clinical research space is a unique business model that has a variety of workflow tasks happening that need to be tracked and visualized.  Some of the basic steps in a clinical research workflow might look like the graphic below.

Within these steps are many tasks, files and status updates that must be tracked to ensure regulatory, financial and administrative compliance.   This has historically been a very laborious and manual process with multiple spreadsheets and paper forms.   Additionally, this is a very real risk for financial and compliance reasons and there have been numerous examples of organizations getting slapped with huge fines when these violations surface.

Typically, the only other option to automate is to use CTMS (Clinical Trial Management System) which is incredibly expensive, time-consuming to implement and still leaves gaps in the end to end process.  For many organizations, this price tag continues to be a barrier to purchasing and using a CTMS which leaves them with using manual processes to manage mountains of processes and data.  Fortunately, there is another option which is likely already in use within your organization.  Enter SharePoint (O365)……

Build the Foundation

The foundation of SharePoint is the ability to store large amounts of data using meaningful metadata in a centralized and secure database.  Let’s think about it this way, if we have 300 projects we are managing most people would instinctively turn to Microsoft Excel to track all the different pieces of data about the projects.  Well, the trouble starts with multiple versions of the spreadsheet being saved and circulated.  It doesn’t take long before we have outdated information and no single source of truth.  Even with using a cloud based document storage such as Box, One Drive and even a SharePoint library you can still end up with users downloading the spreadsheet, saving and distributing multiple versions of the document.

Utilizing a custom SharePoint list to manage the data rather than a spreadsheet ensures the single source of truth and allows multiple users to edit/manage the projects.   So that’s step one, get your data into a list.    Once you do that you have endless opportunities to take those discrete data points about different studies/projects and create powerful dashboards using Power BI (also part of O365).

Leveraging the power of SharePoint also allows you to link related document libraries to your clinical trial to create a one stop record where a user can see all the relevant details about the study (i.e. Principal Investigator, sponsor, budget, milestones, notes, end date, etc.) as well as linked documents such as CTAs (clinical trial agreements), patient visit logs and financial documents.  Additionally, with the new features in SharePoint 2016 and the most recent release of O365 there are endless possibilities for creating custom forms (or apps) using Power Apps as well as Microsoft Flow for automating the workflow.

But what does this really look like in action?  Let’s say I am an investigator with a potential trial, first I log the relevant details to our SharePoint database using a custom form.   A notification is sent to the appropriate administrative staff to begin negotiation and all the pre-award and regulatory tasks that need to be in place prior to beginning a trial.   The staff uses the appropriate SharePoint libraries for the essential documents and updates the main record in the list with notes and statuses so there is an easy, central way to find out information about each study.  At the same time, you typically can integrate with your Regulatory SOR (source of record) to automatically update the regulatory approval status (such as IRB and RSC approvals).  Once a study is ready to begin, a status change or workflow task triggers an official “Go” letter to begin study conduct.   Throughout the course of the study, the workflow can be used to update overall statuses, patient screening and enrollment numbers via the milestone or visit logs which in turn triggers invoicing and financial tasks.  Using Power Apps we can build a mobile application that clinicians can use to quickly look for open trials for patients as well as request enrollment which in turn will boost the revenue per trial.

Results

Once the time and effort have been invested to build this what kind of ROI can be expected.  When an organization has a large portfolio of trials it gets increasingly difficult to manually track all the moving parts involved.  This usually results in lost revenue due to lack of visibility.  In real world examples, a large research organization knew that they were not generating the amount of revenue they should be because there was no central database of the hundreds of trials they were involved with at any given time.    By implementing the above strategy clinical trial revenue and internal IRB fees increased over 100% in a single year (to the tune of 2.5 million in revenue).  This was simply because for the first time in their 30-year history there was a centralized database and visible tasks to invoice and track enrollment.

A secondary benefit (above the recovered revenue) has been the ability to mine data from the research database which has been a great help in business development efforts and key business decisions.  For example, analyzing the funding sources and revenue per study has allowed this organization to pursue (or decline) opportunities they wouldn’t have been aware of without the transparency in the data.  The ability to perform this analysis and create powerful and visual dashboards is all done using Power BI which is fully integrated with SharePoint.  Additionally, being able to visualize the pipeline of upcoming studies allows for accurate resource planning to handle the volume of work.

In summary, with the power of O365 a clinical research organization could implement a robust CTMS at a fraction of the cost with very real, immediate return on their investment.