At the end of July, Adlib team welcomed our long-time partner and industry expert, Keith Parent, at our Toronto office. Keith Parent is an owner and principal business developer at Court Square Group - an IT Managed Service provider for life science companies, from startup to market leaders, and owner of life science point solution RegDocs365. Headlining the day’s information session, Keith inspired with his passion for innovation via automation of the everyday challenges faced by clinical research associates (CRAs) and trial administrators (CTAs).
Decades of pharmaceutical industry knowledge gathered through deep connections with his customers and industry leaders, along with a thorough understanding of IT infrastructures and ecosystems, give Keith a unique perspective on how to help solve the challenges experienced by the pharma and CRO companies with automation and AI-based solutions.
During the industry overview session, Keith took the Adlib team through the full drug development cycle, from pre-clinical to market launch stages. At each stage, he highlighted and expanded on bottlenecks caused by inefficient and manual document processes that result in FDA approval and product launch delays. A good chunk of our discussion was focused on the clinical stage and the preparation of the Trial Master File.
During the session, we have identified top 5 challenges experienced by the CRAs and CTAs when it comes to TMF management:
- Manual validation, qualification and preparation of trial documentation, like meeting minutes, monitoring site reports, etc. Research associates receive volumes of documentation from trial sites as email attachments, in addition to various documents that need collation and further processing generated during weekly status calls with the sponsor, such as meeting minutes, status reports, etc. The CRA then opens each document, validates that all information is present, qualifies the format and page orientation, and saves the file in the appropriate folder in the TMF using templated naming conventions. The process is straightforward and takes anywhere from 5-8 minutes of manual work per document which makes it a suitable candidate for automation, helping CRAs redirect their time towards more complex tasks.
- Ensuring high-fidelity of data received from sites. The electronic means of information capture have significantly helped the industry standardize the quality and format of the trial data. However, manual data capture still happens at trial sites (more frequently at rural sites compared to metropolitan) which renders the documents completely unsearchable, even once they have been scanned. This means that the documents need to be reviewed, digitized, classified and tagged with appropriate metadata manually by a person. Automating this time- and labor-intensive process can help CRAs free-up anywhere from 30 min to a few hours of their time depending on the type of document received.
- Managing up-to-date documentation for Principal Investigators (PIs) at each site. It is common for CRAs and CTAs to manage 1572 Forms for several TMFs for multi-site studies. There are a few challenges associated with ensuring the up-to-date status of all 1572 forms:
- Turnover at trial sites: for every new PI and sub-PI staff changes at the trial site, the site coordinator must fill out a new 1572 form with all the appropriate information. Even a small trial with several sites may carry many 1572 forms per site. At the conclusion of the trial, a clinical summary report must include a report on 1572s. Today, a lot of times this process is performed manually by the CRAs and can take from a few hours for a small trial with 1-2 sites to several weeks for a large trial with 100+ sites. As a result, it is usually compiled only once towards the end of the trial leaving minimal time for fixing any errors or missing information.
- Time-bound nature of the PI documentation. Zone 5 of the TMF contains site-level PI’s time-bound documentation such as a CV, financial disclosure, GCP and other training certificates. Each of these documents expire at random time intervals and it is up to the CRAs to ensure all these records are updated in the TMF before their expiry date.
- Standardization of 1572 format across all the sites. While the format of the form is standard, a common issue is encountered in the section containing the investigator’s full name where it can be recorded in different variations, i.e. Harold Miller III, Harry Miller III, Harry Miller, etc. These instances can accidentally be recorded as different clinical investigators when they all refer to the same person.
- Classification of documents and correspondence. In itself, the task of classifying trial documentation and email correspondence is straightforward in most cases and takes a few minutes per item. For a CRA that manages thousands of documents across multiple TMFs, classification and distribution of documentation into appropriate zones and sections of the TMF can add up to 10-20 hours per week.
- TMF and trial documentation transfer. Sometimes regulatory submissions to the FDA, EMA or other, are prepared by the same organization that was managing the trial. Other times the TMF and other trial documentation may change multiple hands before it reaches the team responsible for regulatory submissions. Depending on the internal systems and procedures used to receive and export the documentation, the final file package may end up losing metadata that's important for the electronic submission format. This results in manually rebuilding the lost metadata and increase the submission delays.
In the second half of the day, Adlib team split up into teams and brainstormed ideas of how Adlib and RegDocs365 platforms can help pharma companies and CROs automate most of this manual work. And to make this more fun and competitive for all, we did all this in a setting of a Shark Tank competition!
While Shark Tank ideas ranged from realistic to futuristic and brought on many laughs, the session made it abundantly clear to us all: that in the world of AI and process automation, almost all clinical trial data prep, analysis and review still primarily rely on human effort.
Our session with Keith identified opportunities to help our customers automate their manual processes. RegDocs365 by Court Square Group and Adlib’s Transform are well positioned to start delivering tangible results to many pharma customers today. And both, Adlib and Court Square Group, are powering up to expand our collective portfolio of solutions for pharmas and CROs further in the coming months.
Speak to us today about the TMF automation solutions we offer our Life Sciences customers.