Novo Nordisk and Boehringer Ingelheim have automated the distribution and collection of regulatory documents from study startup to study closeout. We asked both companies to make the business case for paperless essential document workflow. Their feedback inspired this article: “The Top 10 Reasons to Automate Your Essential Documents.”
(Both Novo Nordisk and Boehringer Ingelheim use software from InnovoCommerce to automate their regulatory document workflow)
#1 – Update study documents faster
It is always faster to update a digital document than a paper document. Consider the time it takes to print an update to a study protocol, insert the update into the protocol while archiving the old version, and documenting those changes in an audit trail. Sponsor study teams and site staff could spend an hour on a task that would have taken 10 seconds in a paperless trial. Keep in mind that in this example, over the course of a Study, the Protocol gets amended multiple times. So, going paperless has an absolute speed advantage over paper.
#2 – Retire old document versions automatically
When you hold two paper versions of the same document in your hand, it can be difficult to identify which document includes the latest changes. During a clinical trial, paperless systems retire old documents as the new document versions are published, so you never have to discern which document is the newest version. Paperless binders at a trial site are always up to date. This simplifies CRA monitoring visits since there is no need to review a traditional paper binder during their routine site visit.
#3 – Harmonize the document distribution process
The success of paper processes is highly dependent on people to stay organized. The standard operating procedure for one site could be vastly different at other sites. Additionally, the sense of urgency to keep paper processes moving along varies from site to site. When automated processes are put in place, they keep things moving along according to a unified process configured in the software system itself.
#4 – Speed up Study Start-up at every site
The fact is, study documents are complicated. Paper complicates distribution because paper moves slowly. And preparing a paper package requires meticulous attention to detail, reviews by individuals, and finally some form of shipping and receiving. For the study site, paper is received with all the other paper that is used to run a business and is processed as time permits when patients are not waiting in the lobby. But electronic study documents move at light speed and are always in a highly organized state, dictated by the workflow of the software system that moves the documents along. This shortens the time for starting up the study at the sites, and site staff have more time to focus on patient recruitment and care.
#5 – Decouple document collection from site monitoring
Unlike paper documents, electronic document distribution and collection is decoupled from site monitoring. Using an electronic study document exchange system, the status of each document is always known. There is no reason to call or visit the site to check the status of a document or to make sure the site has filed all the paper artifacts correctly. This saves time not only for monitors, but also for the busy study site staff.
#6 – Find every document in one place
The world of paper is a complex set of processes and places. Most of these processes have to do with moving the paper and most of the places are ad hoc repositories (for example an email in-box), until eventually every paper document ends up in the correct place. Electronic systems move the study documents using workflows and keep every document in the same repository while moving the document through each stage using distribution requirements. This gives sponsors a huge cost savings while ensuring there is only one record of truth pertaining to all regulatory study documents.
#7 – Improve site satisfaction in a big way
By any measure, the elimination of paper at sites increases site satisfaction. Sites that use electronic systems provided by the sponsor or CRO never need to wonder what actions are needed by the sponsor, CRO or the site staff. Tasks are presented at the correct time and when action is required (like acknowledge or sign). Site staff is never asked to move regulatory documents from one place to another. They never need to print a document to sign it, and they never need to file a document since all of this happens automatically in an essential document shared system.
#8 – Reduce time required for Quality Assurance
In a paperless system, documents are distributed, edited, and collected within the system, creating an indisputable audit trail. The dates, times, user identity, and various metadata of a document are recorded and updated automatically. This removes a significant QA burden by eliminating some QA checkpoints, and enables the quality assurance staff to review and approve hundreds more documents each day.
#9 – Achieve a contemporaneous eTMF
The reason ICH introduced the concept of contemporaneousness is that in the past, many paper artifacts were found to contain curious details. For example, a signed document that shows the signer’s receipt date is later than the signers signature date. Paper-based processes are often paused for any number of reasons that have nothing to do with the clinical trial, leaving staff to try and catch up on work by signing with dates that “should” have been met. This can result in a sloppy TMF and could give regulatory inspectors a reason to look further into a trial’s accuracy.
#10 – Solve the completeness challenge
The biggest challenge to maintaining a state of completeness during a study can be managing paper documents. Paper by its very nature is an offline product that exists outside of the clinical trial itself. As the sites get added to the trial or removed from the trial, the complexity of tracking documents increases substantially. TMF managers even create “place holders” in their eTMF for paper documents they expect to receive, and then run reports showing the place holders so they can contact sites to request the missing documents. In a properly designed electronic system, the expected count of the study documents based on currently active sites is always known along with the actual completion status of the document at any point in time. The completeness challenge is solved because documents are never lost, delayed, or missing. As soon as a document is signed, it appears in the QC work area, ready for inclusion in your eTMF.
The transformation from a paper-based system to a paperless model in clinical trials is a goal at many clinical sponsors and research organizations. Connecting your eTMF to a clinical trial automation product is key to this transformation. The software product that helped achieve this goal at Novo Nordisk and Boehringer Ingelheim is the Study Collaboration Portal and can be further researched at www.innovocommerce.com