While chemical reporting is an important part of a pharmaceutical chemist’s job, it also can be a very stressful, complex one. Outsourcing-Pharma recently connected with Jesse Harris, marketing communications specialist with ACD/Labs, on ways to alleviate common pain points in the scientific reporting process, and how to get the most of out of chemical reporting.
OSP: Could you please share some of the considerations involved in chemical reporting in a pharma environment?
JH: It goes without saying that the pharmaceutical industry is heavily regulated. Like any heavily regulated industry, reports must comply with local laws. Reports are also used to document results and decisions, and communicate with collaborating teams and departments, management, and/or partner organizations who make decisions based on these documents. For this reason, accuracy is critical in a pharmaceutical environment. Accuracy should be supported by file permissions and security, as data needs to be reliable.
Efficiency is the second factor. Companies want to get the most from their employees, and scientists want to focus on their research. Completing reports is time-consuming; you must hunt down data, process and understand it, and then add it to a report file. This workflow is often part of a routine, so any inefficiencies are repeated many times.
Reports also need to be usable. Information should be clear and digestible, so the reader can quickly understand the critical results. One aspect of usability is consistency, which improves the comparison of experimental results. Reports should also be searchable, which will significantly enhance findability. This can be accomplished through a combination of report design, file handling best practices, and metadata.
Beyond these general considerations, it depends on the specifics of the report. Some reports are optimized for sharing with multiple departments, while others are designed to track factors relevant to only one team. Long-term storage may be critical for specific reports, while flexibility may be a priority for others. The design should be based on the role being addressed within the broader organization.
OSP: How has the technology used to manage the process evolved in recent years?
JH: Some equipment and software have built-in features that automatically generate accurate and easy-to-read reports. Assuming these are working correctly, they are excellent, though they often require expert review.
We are also seeing report template builders that are more flexible, which then create reports that are rigid and consistent. Reporting requirements are workflow specific; reporting templates need to be flexible enough to meet the needs of researchers. But once created the template is created, the final reports should be consistent.
Scientists often use standard office productivity software to complete reports, such as Microsoft Word, Excel, or PDFs. These have the advantage of being accessible and offer flexibility when preparing their reports. Unfortunately, these file types are not designed for handling analytical data, which can only be included as numerical and textual data (peak lists), or images of spectra and chromatograms. The flexibility of these files can also cause consistency issues and transcription errors.
While there have been plenty of advancements in reporting tools, some teams still use pen-and-paper. This low-tech solution may be easy to implement but has many other challenges. The information is unsearchable, there are legibility issues, and there are concerns about preserving records.
OSP: Can you share what the “common pain points” are?
JH: Writing reports is time-consuming. It is not just a matter of ticking off boxes; you must gather up data, which often needs to be processed or validated and may be spread across multiple databases. Once the preparation is complete, a team member (usually the team leader) must compile the report.
Reporting is also unpleasant. It is stressful to complete documents sent to regulatory bodies or senior management. It is also tedious to fill in the same reports weekly or monthly. It seems contradictory to say reporting is both stressful and tedious, but it’s true!
Since most scientists prefer to focus on generating results, they sometimes don’t put enough effort into reporting. Reports are not completed on time, or sections are not filled out correctly. These issues can lead to more significant problems in the future.
The long-term usability of reports can also be a challenge. Reports are often created to maintain a long-term record. When the time comes to retrieve the information, you cannot find the correct file, or it does not include what you want. This issue is particularly problematic for paper-based reports.
OSP: How typically do reporting personnel deal with these challenges and obstacles?
JH: Extra time and effort are generally the solution. Time is spent gathering up the data and adding it to a report, more time is spent reviewing and editing the documents, and still more time is spent searching for files in the future. This isn’t ideal, but it is the most common solution.
Automation is another approach. Automated workflows can reduce time investment while increasing accuracy, though they can be challenging to implement. These automation systems often struggle when more than one type of data is being used or when results are assembled from multiple laboratories.
OSP: What are some of the ways teams can alleviate the pain points while ensuring efficiency, accuracy, and usefulness of the info?
JH: Step one is having a reporting strategy. What decisions are you trying to make based on the report, and what information do you need for those decisions? Scientists can sometimes include more data than necessary based on the idea that extra data will be available “just in case”. This leads to reports that are bloated and difficult to read. “Just in case” data is best left aside and can be retrieved from a database in situations where it is necessary.
Once you have developed a reporting strategy, you should now build a template. This template should be structured to highlight the most relevant results to the questions you are attempting to address, as well as clearly meeting the relevant regulatory guidelines. Feature the most critical data early and sequence results in a manner that is easily understood.
Templates should also be developed to reduce the time necessary to prepare reports. Minor tweaks can significantly increase the work done by the computer and simplify the work for the end user.
It should be emphasized that the time savings of an automated reporting system can be substantial. Most analytical results are used in at least one report, and analytical chemists can spend considerable time preparing these documents. For reports containing multiple types of analytical data, the ability to automatically compile several data types into one report saves some of our customers over 5 hours a week per employee.
OSP: Could you share some of the ways ACD/Labs might help?
JH: All our vendor-neutral software applications provide built-in functionality to report data in a manner that's intuitive for scientists, is comprehensive, and provides context. This includes NMR spectra, chromatograms, biotransformation maps, or any other chemical data. This is especially useful for assembling multi-technique reports, which can be exported directly to Microsoft Word. You can also use scripts to create PDF reports of analytical results with a couple of clicks.