This blog entry is the first in a series of how to establish effective programs for safety system implementations.
Proper planning is essential when it’s time to implement a new system for your organization. Here’s how to get started.
All large-scale, multi-year and highly impactful new system implementations face many challenges and risks. Due to their stringent regulatory compliance requirements, implementing new systems within life science is even more challenging, particularly in R&D, manufacturing, regulatory, and pharmacovigilance.
In addition to standard program measures of success – timelines, budget targets, functional and business objectives, and end-user satisfaction – implementing these systems require following exhaustive protocols and resilience to ongoing internal and external audits. And because of its mission to monitor and report on patient safety via highly complex reporting rules, a new pharmacovigilance (PV) system may be the most challenging.
However, companies can take a deliberate and methodological planning approach to minimize these challenges and efficiently meet desired outcomes. And the first step is to answer essential questions.
More Questions & Decisions to Make
Now, let’s say the business case is complete, and your organization has chosen a new platform for safety reporting. While the most significant decision is made, many equally important questions and decisions lay ahead:
- Is process improvement a key objective?
- Are there interfacing systems that have real or perceived deficiencies?
- Are there significant pain points within the legacy system that the new platform must address?
- Does my organization clearly understand what “life will be like” when the new platform is operational?
- Is my organization genuinely ready to take on this effort?
Answering these questions may be difficult, but arriving at the correct ones will set the program on a path to success.
Want to receive answers to your PV system questions more easily? If so, engaging in these major, early tasks will set the program on a path to success.
- Discovery: Perform the due diligence to align business objectives and the expected outcomes of the new safety platform from the perspective of people, processes and technology.
- Setting Up the Program: Develop a program organization that establishes effective governance and fosters deep partnerships between businesses, technology and third parties that will compose the program team.
Understand Business, Functional and Process Requirements
As there is only so much to glean from system demos and playing around in vendor sandboxes, organizations frequently take a leap of faith when selecting a new technical platform. That’s why organizations – a combination of key business and technical resources – should dedicate significant capital resources and time to “right-fit” the platform to the organization.
Within a safety system, this translates into a discovery period to identify core business processes and requirements, including, but not limited to
- Case intake and processing
- Case submissions
- Aggregate and periodic reporting
- Signal detection
The discovery period should define current-state (legacy system) baselines, define the future-state vision, and, through deep dives into the new platform capabilities, assess these capabilities against both the baseline and future-state vision.
Identify System Requirements
In parallel, your tech organization should be conducting a similar exercise of current- and future-state assessments. Here are some key questions you should ask:
- What upstream (case intake) or reference systems (product master data, registrations, MedDRA) will be impacted?
- Are there new interfaces to be built?
- Are there opportunities to improve existing interfaces (partner and health authority gateways)?
- Can aging, ancillary systems be retired?
- Will the existing analytic and reporting platforms fit for purpose in the coming years?
In short, you should evaluate all technical components of the legacy environment to complete the future-state vision.
By completing these discovery activities, your organization can produce a baseline of system scope and the future-state roadmap necessary for building the program.
Setting Up the Program
Define the Organization
By the sheer ambition and scope of such an endeavor, and with a working team likely to number in the hundreds, you should take great care when building the program. Do it in a way that clearly defines hierarchal and matrixed models of responsibility and involvement, which will foster communication and knowledge sharing.
You might want to think about the team with a new mindset. Create a team as if you were standing up a brand-new organization, which will require clear lines of responsibility and delineation of roles, responsibilities, ownership and decision-making. Also, consider that many team members, including business resources, will assume near or completely full-time roles. It’s almost like it’s a new job (albeit a temporary one).
Identify the Workstreams
Now, how to organize the work? Although every organization is different, it’s likely a new PV system will require the following workstreams.
|Process||Continued and ongoing business process refinement and alignment with business objectives resulting in new or revised SOPs.|
|Configuration (Case Intake & Processing)||Multi-channel case intake and core processing workflows, ICSR rules, privacy, etc.|
|Integration||Process alignment, technical requirements and implementation.|
|Reference Data||Modeling and refinement of the product, registrations, reporting groups, data sheets, watchlists, and standard dictionaries like MedDRA, WHODrug, JDrug, etc.|
|Aggregate Reporting||Aggregate reports and line listings are prepared for HA submissions.|
|Analytics/Advanced Reporting||Ad-hoc reporting for operations, compliance, and signal detection.|
|Migration||The migration of data and documents from legacy system(s).|
|Document Management||PSMF, aggregate and other submission reports.|
|Testing/Validation||Testing/Validation group with oversight of most, if not all, the technical work.|
|Data Quality||Independent workstream to ensure consistency of data (transactional, aggregate, and reference) across the safety ecosystem.|
|Change Management||Organizational readiness, communications, and training, among other activities.|
|Japan||The distinct but comprehensive workstream encompassing many of the abovementioned workstreams.|
|Technical Deployment||A dedicated team to oversee and manage the UAT and production deployments of all new systems and system upgrades.|
|PMO||A dedicated team composed of a workstream, project, and program-level resources.|
(In Part II of our blog series, we will take a closer look at many of these workstreams, some of which, based upon the need, may need to be subdivided into smaller working teams.)
Implementing a new PV system takes planning to ensure success. But with the initial round of discovery complete, and the organization defined, you position your company to stand up the program. In the next entry of this blog series, we will detail concrete steps to accomplish this.
Daelight Solutions helps pharmaceutical, biotech and medical device companies plan for new PV systems. Contact us to learn how we can help.