This blog entry is the second in a series on how to establish effective programs for safety system implementations. Read the first entry here.
Implementing a new pharmacovigilance system requires a lot of planning. And part of that strategy includes Case Intake and Processing.
Background
In the first entry of this series focusing on new drug safety/pharmacovigilance systems, we discussed two main starting points – The Discovery Phase and Setting Up the Program. It’s important to understand those concepts before we move on to the next parts of the process.
Here is a summary of the key takeaways from that blog entry.
Discovery
This stage should be multi-faceted, unearthing both current and future state business processes as well as functional and compliance requirements. It should also include a deep analysis and assessment of the functional and configuration capabilities of the new platform.
Lastly, organizations should fully assess the technical safety ecosystem, making determinations of new, modified or potentially obsolete integrating systems and/or data sources. Ultimately, the work product produced by this program phase sets the foundation for successful project execution.
Setting Up the Program
Implementing a new safety system is a massive endeavor, requiring a team consisting of a wide collection of internal and external resources across many subject domains and skill sets. In addition, building a cohesive team will require its own unique organization, with both hierarchal and cross-functional teams.
The organization should have clear lines of responsibilities, ownership and decision-making. The maturity of this new organization (and the communication of it) will ultimately pave the way for identifying the right talent with which to build the team, as well as onboarding that talent at the right time.
Safety Program Workstreams
We previously discussed the core workstreams that typically compose a Safety Program, namely:
- Configuration (Case Intake, Processing and Submissions)
- Integration
- Reference Data
- Aggregate Reporting
- Advanced Reporting & Analytics
- Document Management
- Validation/Testing
- Data Quality
- Change Management
- Technical Deployment
- Japan
- PMO
Loosely following end-to-end Safety System processes, in this blog entry we will start with Case Intake and Processing from the perspectives of people, processes and technology.
Case Intake & Processing
Case Intake and Processing is the process of collecting, assessing, and filing all incoming reports of adverse drug reactions and other safety-related events. This critical process helps to identify and manage safety issues that could affect the safety profile of a drug or therapeutic agent. It also involves the classification and coding of the reports, as well as documentation of the applicable regulatory reporting requirements. This ensures that the safety data is properly tracked and reported in a timely manner to the appropriate regulatory authorities.
Questions to Consider
When it comes to Case Intake and Processing, here are some key questions that organizations should consider:
- Where are Adverse Event (AE) cases coming from and at what volumes and in what formats?
- How efficient are the mechanisms by which Safety Systems receive timely case reports, and what are the current pain points? Adverse Event sources to consider:
- Business partner and health authority channels
- Clinical trials (pre- and post-marketed)
- EudraVigilance
- Customer call centers
- Product quality complaint systems
- Other internal case triaging systems, including literature surveys
- What PII rules are (or should be) in place within the new safety platform as well as feeding system(s)?
- To what extent are cases currently auto-coded, re: indication, event, product(s), and seriousness?
- Does the new platform deliver on the promise “no-touch” case processing for non-serious cases?
Ultimately, from the perspective of Individual Case Safety Reports (ICSRs), the new safety platform is the gatekeeper of data quality for ICSR case inputs and outputs – the hub of many spokes.
And toward that end, how do you ensure that the new platform meets its potential – for effective business processes, system functionality and system integration?
Hopefully, during the discovery phase of your program, your organization has already identified case intake strengths AND pain points. This is your starting point – providing you pathways to an improved future state.
Next Steps
With all that in mind, here are some next steps your organization should take:
Step 1
Establish a Case Intake/Processing workstream (and potentially sub-workstreams) consisting of a cross-functional group of stakeholders, including, but not limited to:
| Role | Descriptions |
|---|---|
| Process Design Experts & Business Analysts | A sub-team focused singularly on case triage/intake business processes, including initial and follow-ups. |
| Case Intake Data Entry Specialists | Resources focused on data requirements for case entry validation. |
| Single Case ICSR Specialists | Experienced Safety Professionals with full knowledge of case processing and global submission requirements. |
| Privacy Subject Matter Experts | Resources with an enterprise view of PII protections within the organization, as well as country-specific regulations to which the system must adhere. |
| Technical Architects/Leads | Key representation from each legacy (or new system) that sends or receives case reports. |
| Case Processing Workflow Analysts | Resources dedicated to defining future-state workflows based upon any number of variables including, but not limited to, therapy area, seriousness categorization, case source, and geography. |
| Change Management Specialist | Having a seat at the table early in the process will facilitate business readiness down the road. |
Step 2
Leverage your existing assets. Operational reports from your legacy system will surely help guide your future state requirements, detailing case volume and throughput (from entry to submissions) across many dimensions (source, case type, seriousness, country, product, and AE Terms). Mining this data will allow the program to allocate resources where they will have the largest impact.
Step 3
In parallel with this workstream, create a separate but parallel technical workstream(s) that takes a holistic view of the case intake ecosystem and develops technical blueprints for overall case intake integration. These blueprints will likely include varying degrees of manual, semi-automated and fully automated methods, but ultimately, alignment with the business needs and the future process is what matters most.
Step 4
Here’s where you pull it all together. Ultimately, the outputs from all of the above activities will lead to comprehensive system requirements. Based on the methodology used, the completeness of these requirements may lead to more detailed business, functional and data requirements. Regardless, your team will have taken significant steps toward defining testable requirements to facilitate configurations and software enhancements or new builds.
(In the next entry of this series, we will shift our focus toward Data Migration, the relatively unglamorous but critically important task for any new system.)
Conclusion
Case Intake and Processing help set up new pharmacovigilance systems by providing a structured and efficient way to capture, store, and process incoming reports of potential adverse drug events. This helps to ensure that the pharmacovigilance system complies with regulatory requirements and provides timely access to the information necessary for assessing the safety profile of a drug.
By providing a standardized process for the intake of reports and a systematic approach for processing the data, pharmacovigilance systems can be more efficiently set up and maintained.
Daelight Solutions provides system implementation services to pharmaceutical, biotech and medical device companies that want new PV systems. Contact us to learn more.