Introduction
Patient safety and accessing safe and effective medicines are critical for big pharmaceutical companies. For this reason, drug safety service providers such as Parexel are required. The company’s query management team, comprised of drug safety associates (DSAs), ensures the quality and accuracy of clinical trial data for Parexel’s sponsored projects. For instance, safety concerns or negative feedback traditionally emerge because of the lack of action.
Moreover, queries can be overdue because of the need to manage suspected unexpected serious adverse reaction cases. Thus, with a team of DSAs and trained personnel focused on query management tasks, case processors can perform their main functions with better outcomes. It will also help to save time and avoid mistakes caused by the need to resolve numerous tasks simultaneously.
Problem Statement and Target Audience
Parexel’s query management team addresses queries from various sources, such as regulatory agencies, investigators, or sponsors. Dedicated query management teams are formed for larger projects, and case processors working on multiple sponsor projects handle the queries. However, this task takes up the case processor’s time, potentially leading to increased errors and missed tasks. The limited budget further compounds the issue because of the need to balance benefits and excessive spending. The target audience for this analysis is Parexel’s management team, which is responsible for drug safety services.
Benefits of Case Quality
It is impossible to overestimate the significance of case quality when processing cases for funded initiatives. High-quality case processing enhances patient safety and medical efficacy and assures fast and accurate data collection, analysis, and reporting (Nik Him et al., 2020). In addition, it lessens the possibility of breaking regulations, which may harm both the sponsor and the service provider’s finances and image. Finally, case quality reduces medical errors and enhances their understanding, which is vital for employees’ learning and training.
Benefits of Case Quality in Processing Cases for Sponsored Projects
Process cases for supported projects with a high standard of quality. Making informed judgments regarding the safety and effectiveness of medications requires precise and trustworthy clinical trial data, which is ensured by this process (Parexel, 2023). Accurate case processing can help identify potential safety issues before they become severe and ensure compliance with regulatory requirements.
One advantage of high-quality case handling is improved patient safety. Thanks to precise data, sponsors can make decisions about labeling and patient selection based on a better understanding of the hazards connected with their goods. High-quality case processing can also assist in identifying unanticipated adverse outcomes, enabling sponsors to take the necessary precautions to reduce risks.
Efficiency gains are another advantage of high-quality case processing (Kowalski, 2021). Case processors can shorten the time and effort needed to address problems by seeing possible issues early in the process. Sponsors can avoid the costs of extensive investigations and remedial activities, which can save time and money.
Query Management Team and Budget Constraints
The query management section at Parexel handles inquiries about sponsored initiatives and is presently managed by a team of four DSAs. However, maintaining a dedicated team for more significant tasks may be difficult due to the related expenses. For instance, the training budget for a team of 5 DSAs can be around $100,000 for two months.
Additionally, salaries for a DSA range from $80,000 per year to higher. This means that significant spending is required. However, a medical error costs around $8,000 per admission and has a high incidence rate (Palmer, 2019). The benefits will outweigh the costs and help to save money. The alternative is using a third-party provider to handle Parexel’s query management needs.
The DSAs’ burden could be lessened, allowing them to concentrate on case processing while guaranteeing a rapid response to inquiries. However, outsourcing can be pricey and might not be practical for smaller projects with tighter budgets (Simonovsky et al., 2019). For this reason, it is vital to select the most reliable option to attain better results.
Pros and Cons of DSAs Performing Query Management Tasks
The use of DSAs for query management activities has both benefits and drawbacks. One advantage is that DSAs thoroughly grasp the data and can immediately see possible problems. They may also give context for the questions by being familiar with the research methodology, which makes it simpler to respond to them.
Nevertheless, this strategy may have some negative aspects. One problem is that DSAs might not be qualified to answer all questions. For instance, some questions need feedback from statisticians or medical specialists who might not be on the query management team. Moreover, it might be difficult for DSAs to prioritize questions and ensure that all duties are finished on schedule when juggling many projects.
Recommendations
Parexel should confidently deploy risk-based quality control strategies to ensure high-quality case processing in its sponsored projects. Investing in the education and training of DSAs responsible for query management will generate numerous benefits, such as increased output speed, enhanced patient safety, and reduced medical errors. It will also help to save costs and avoid spending on compensating for harm done to patients.
Because of budget constraints, outsourcing query management to a specialized firm can also be considered. It can alleviate the workload of DSAs and ensure timely responses to inquiries. This will enable Parexel to maintain high standards for its sponsored projects, increase productivity, and provide better patient safety.
Conclusion
Altogether, Parexel’s effective query management practices can significantly improve the quality of case processing and patient outcomes. High-quality case processing can enhance efficiency, regulatory compliance, and patient safety. However, maintaining a dedicated query management team may be challenging due to resource and financial constraints. Parexel could consider implementing a risk-based quality management approach to case processing, allowing DSAs to prioritize high-risk areas and ensure regulatory compliance.
References
Kowalski, D. (2021). Five benefits of risk-based quality management (RBQM) for Clinical Trial data. Insights from Our Labs to Yours. Web.
Nik Him, N. F., Noor Aina Amirah, & Hassan, A. (2020). Exploratory factor analysis of safety management commitment and safety administration in the context of construction industries. Asian People Journal (APJ), 3(1), 132–140. Web.
Palmer, J. (2019). Lehman report analyzes cost of medical errors despite healthcare progress. PSQH. Web.
Parexel. (2023). Drug safety and pharmacovigilance. Parexel. Web.
Simonovsky, E., Schuster, R., & Yeger-Lotem, E. (2019). Large-scale analysis of human gene expression variability associates highly variable drug targets with lower drug effectiveness and safety. Bioinformatics, 35(17), 3028–3037. Web.