Although chemical reporting is an important part of a pharmaceutical chemist’s job, it can also be very stressful and complex. Outsourcing-Pharma recently reached out to Jesse Harris, marketing communications specialist at ACD/Labs, about ways to alleviate common pain points in the scientific reporting process and how to get the most out of chemical reporting.
OSP: Could you please share some of the considerations involved in reporting chemicals in a pharmaceutical environment?
JH: It goes without saying that the pharmaceutical industry is highly regulated. Like any highly regulated industry, reporting must comply with local laws. Reports are also used to document findings and decisions, and communicate with collaborating teams and departments, management and/or partner organizations who make decisions based on these documents. For this reason, precision is essential in a pharmaceutical environment. Accuracy must be backed by file permissions and security, as the data must be trusted.
Efficiency is the second factor. Companies want to get the most out of their employees and scientists want to focus on their research. Completing reports takes time; you need to find the data, process and understand it, and then add it to a report file. This workflow is often part of a routine, so any inefficiencies repeat themselves multiple times.
Reports should also be usable. Information should be clear and digestible, so that the reader can quickly understand critical findings. One aspect of usability is consistency, which improves comparison of experimental results. Reports should also be searchable, which will greatly improve searchability. This can be accomplished through a combination of report design, file management 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 a single 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, easy-to-read reports. Assuming they’re working properly, they’re great, though they often require expert review.
We are also seeing more flexible report template builders, which then create rigid and consistent reports. Reporting requirements are workflow specific; reporting templates should be flexible enough to meet the needs of researchers. But once the model is created, the final reports must be consistent.
Scientists often use standard office software to write reports, such as Microsoft Word, Excel or PDF. These have the advantage of being accessible and of offering flexibility in the preparation of their reports. Unfortunately, these file types are not designed to handle analytical data, which can only be included as numerical and textual data (lists of peaks) or images of spectra and chromatograms. The flexibility of these files can also lead to consistency issues and transcription errors.
Although there have been many advancements in reporting tools, some teams still rely on pen and paper. This low-tech solution may be easy to implement but presents many other challenges. Information cannot be found, there are readability issues, and there are concerns about the preservation of records.
OSP: Can you tell us what the “common pain points” are?
JH: Writing reports takes time. It’s not just about ticking boxes; you need to collect data, which often needs to be processed or validated and can be spread across multiple databases. Once the preparation is complete, a member of the team (usually the team leader) should write the report.
The reports are also unpleasant. Filling out paperwork sent to regulators or senior management is stressful. It is also tedious to complete the same reports weekly or monthly. It seems contradictory to say that reporting is both stressful and tedious, but it’s true!
Since most scientists prefer to focus on generating results, sometimes they don’t put enough effort into reporting. Reports are not completed on time or sections are not completed correctly. These problems can lead to bigger problems in the future.
The long-term usability of reports can also be a challenge. Reports are often created to keep a long-term record. When the time comes to retrieve the information, you cannot find the right file, or it does not contain what you are looking for. This issue is particularly problematic for paper reports.
OSP: How do reporting staff generally deal with these challenges and obstacles?
JH: Extra time and effort is usually the answer. Time is spent gathering data and adding it to a report, more time is spent reviewing and editing documents, and even more time is spent researching files in the future. It’s not ideal, but it’s the most common solution.
Automation is another approach. Automated workflows can reduce time investment while increasing accuracy, although they can be difficult to implement. These automation systems often encounter difficulties when multiple types of data are used or when results are assembled from multiple labs.
OSP: In what ways can teams mitigate pain points while ensuring efficiency, accuracy, and usefulness of information?
JH: The first step is to have 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 additional data will be available “just in case”. This leads to bloated and hard to read reports. It is best to set aside data “just in case” and retrieve it from a database in situations where it is needed.
Once you have developed a reporting strategy, you now need to create a template. This template should be structured in a way that highlights the most relevant results to the questions you are trying to answer, as well as clearly adhering to relevant regulatory guidelines. Present the most critical data up front and sequence the results in an easily understandable way.
Templates should also be developed to reduce the time needed to prepare reports. Minor changes can significantly increase the work done by the computer and simplify the work of 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 multiple types of data into a single report saves some of our customers over 5 hours per week per employee.
OSP: Could you share some of the ways ACD/Labs could help you?
JH: All of our vendor-neutral software applications offer built-in functionality to report data in a way that is intuitive for scientists, comprehensive, and contextual. This includes NMR spectra, chromatograms, biotransformation maps or any other chemical data. This is particularly useful for assembling multi-technical reports, which can be exported directly to Microsoft Word. You can also use scripts to create PDF reports of analytical results with just a few clicks.