Hex image

Filling Safety Database Gaps with Business Process Management Solutions

2 people doing research

PPD’s Abiola David, pharmacovigilance director, Raza Mohammed, pharmacovigilance director, Neil Walker, optimization associate director, pharmacovigilance and regulatory affairs, write about our business process management solution and its benefits.

Modern safety databases are excellent at capturing safety information and enabling users to prepare submissions to regulatory authorities. However, they do not provide a good mechanism for managing and tracking the individual steps required to process safety information from receipt through submission. They also do not provide detailed information needed to properly ensure compliance, metrics around case processing or facilities to help manage resources and quality.

These key steps are important as they provide oversight on the full journey of a single case from point of receipt through to the submission. With a more complete oversight, robust practices can be put in place and ensure cases get to the regulatory authority on time and in good quality. It enables us to foresee challenges in processes, resource management, identify trends and proactively address them, ultimately, allowing us to continuously enhance the process.

To address these gaps, PPD decided to implement a business process management solution (BPMS) to work in conjunction with the safety database (SDB). The BPMS solution is needed for additional functionality above and beyond the SDB capabilities in the following critical areas.

The specific BPMS tool PPD implemented is an internally developed tool called the Safety Tracking System (STS) that is customized to meet the unique needs of the pharmacovigilance (PV) industry.  Below are the ways in which the BPMS tool has improved the process:

Process Automation – STS provides a robust process automation functionality that enables PPD to automate many of the PV processes, including the processing of adverse event/ICSR reporting. The tool significantly streamlines our processes enabling us to drive efficiency and reduce overall costs.  Specific areas where these automation capabilities are used include:

  • The capture of incoming SAE reports and follow-up information and automatic routing to the appropriate processing team members. This significantly reduces the amount of time spent on intake activities and helps to ensure information is not misrouted.
  • The generation of follow-up queries and the tracking of those queries through multiple follow-up attempts. This reduces the overall time spent on follow-up activities and improves timeliness of follow-up requests and the processing of responses.
  • The capture and filing of both source documentation and documentation generated during case processing activities.  This reduces the amount of time spent reviewing the Trial Master File and ensures documentation is filed in a timelier manner.

Resources Management – STS automatically assigns cases to individual users based on resource availability and provides robust functions for monitoring user productivity and adjusting resource assignments as needed.  The system provides managers real time data on cases volumes, the tasks required to be performed on those cases, when those tasks are due and the resources assigned to complete the tasks. This enables managers the information they need to quickly identify potential resourcing issues, and the system then provides managers with the robust tools they need to quickly reassign work as needed. These advanced resource management capabilities provide much more granularity and control over the basic group assignment capabilities found in most Safety Databases in which items are assigned to a group of users and the users have to claim their own work. Using STS enables PV management to ensure the most efficient allocation of resources and to effectively manage fluctuations in case volumes.

QC Tracking – STS ensures that quality control checks are performed in line within our business processes and captures detailed data around those check.  This enables PV to identify and correct quality issues before the final submissions are completed.  Additionally, the data captured during the quality checks enables PV management to measure quality at both an individual user and project level, and readily identify any quality trends and target areas for quality improvement activities. Using STS to capture and monitor quality control checks helps PV ensure that the highest quality deliverables are provided.

Oversight/Compliance – STS provides a full range of metrics to provide real time oversight of PV processes, enabling PPD to ensure that we remain compliant with all regulatory and client timelines.  This includes the number of open/closed cases, cases completed/submitted within timelines, open cases with outstanding follow-up queries and counts on the number queries generated.

Benchmarks – STS enables PV to compare processing metrics across all our clients to establish processing benchmarks. This enables us to identify when an individual client is outside the norm and target potential efficiency gains.

In addition to core AE/ICRS processing, PPD has leverage the BPMS capabilities of STS to automate other related functions. These include literature reviews, safety reporting to Regulatory Authorities and Ethics Committees, electronic trial master filing (eTMF) filing, aggregate reporting tracking and medical monitoring functions including the processing of Physician Assessment Diagnostic Forms (PADFs) and various medical reviews.

In summary, PPD has found that implementing a BPMS has significantly improved the efficiency of our processes and allocation of resources, enabling us to provide more cost-effective solutions. In addition, use of BPMS provide increased oversight of every case at each point in the processing cycle, leading to better quality cases, timely submission and improved customer experience.