Prudentia partners with our clients – from conception to integration to deployment – for safety database implementations. We develop project and resource plans for the full implementation of safety database solutions.
We develop user requirements and conduct conference room pilots for the selection of vendors. We lead PMOs for project planning and governance. We lead business process and technology work streams for the requirements definition, technical architectures, and designs.
We lead validation streams for validation plans, operational qualification, and
performance qualification. We have vast experience implementing large safety databases such as Argus and ARISg.
Prudentia has evaluated, developed, and remediated pharmacovigilance processes starting with individual case safety reports (ICSRs) across clinical trial and post marketing (receipt, processing, and submissions), to periodic reporting (PSUR/PBRER, PADER, DSUR, JPSUR, JDSUR), to signal detection, and overall risk management.
We evaluate and design global case processing solutions for companies with a range of ICSR volumes (from fewer than 1,000 cases/year to over 250,000 cases/year). Our experience spans multiple therapeutic areas, multiple geographies (US, EU, Japan, Latin America, South America, Africa, and Australia), and multiple submission types (paper, XML through gateway, XML through portal (EVWEB or WebTrader). We help companies design the PV organization and/or select an outsourcing solution.
Prudentia understands that PV operations is dependent on several supporting processes. We have experience designing and implementing many of them. We author process documents (Work Instructions / Job Aids, SOPs, policies), training
plans, training curricula, and training materials. We design and implement ICSR compliance monitoring and quality management solutions. We author safety data exchange agreements (SDEAs) and manage the ICSR timelines and other
commitments associated with each agreement. We author and maintain Pharmacovigilance Safety Master File (PSMF). We implement processes for safety database (SDB) master data maintenance, distribution rules, and SDB change control.
We help organizations prepare for inspections as well as implementing corrective actions from inspections. We conduct mock inspections and conduct audits that are both PV and IT/Systems focused.
Prudentia migrates safety databases. Our team will assess the quality of data from source to target, develop the mapping requirements, develop the translation programs, and develop the validation strategy to ensure the records are migrated accurately and completely.
We have experience migrating between custom safety databases as well as ARISg, Argus, and Clintrace.
Prudentia manages PV separations (i.e., divestitures) requiring process and safety database bifurcation, PV mergers requiring business process and safety data integration into a global system, and business process outsourcing (BPO) analysis, vendor selection and transition to onboard partners for managing all or select pharmacovigilance services based on client requirements.
We have experience in separating large safety databases where the existing and newly formed companies each have multiple product portfolio and large case volumes as well as single product spinoff companies who have transitioned parts of the PV system (e.g., safety database, single case processing and aggregate report authoring) to a PV vendor.
Prudentia understands the PV user metrics and report requirements and has developed a vast library of compliance, volume and signaling reports as well as supports ad hoc query requests from PV Associates, Medical Reviewers and Safety Scientists.
Prudentia has experience with building reports from ARISg and Argus using various solutions such as Business Objects, Cognos, Crystal Reports and OBIEE. Prudentia has also developed a user friendly business intelligence application, PV TREND, for end users to design their own reports via simple point and click.
Prudentia assesses and implements quality, compliance, and performance monitoring solutions for ICSR and aggregate reporting. Our risk based quality services will identify and track quality issues and provide the foundation for continuous improvement.
Our compliance and performance services will help you implement effective metrics to manage expedited ICSR and aggregate reporting timelines. Our consultants have a proven record of leading organizations through corrective actions to implement compliance and performance monitoring solutions.
Prudentia assesses, designs, and writes SOPs across case processing, aggregate reporting, signaling, change control, dictionary management, configuration, and validation.
Our team comes with years of experience across large and medium drug safety organizations defining and implementing these processes.
Prudentia gets you ready for regulatory inspections. We guide you through inspections. We help you closeout and respond to inspections. Our team conducts mock inspections of case processing, aggregate reporting, and signaling for both pre- and post-approval.
Our team develops a plan to address the gaps and get the organization’s practices and documentation in place. Our team works with your legal, regulatory, clinical, and affiliates to organize a responsive and effective inspection team. Our team develops strategies for addressing inspection findings and keeping regulators continuously updated with the progress of corrective and preventative actions.
Prudentia provides program management office services to run a company’s large programs or project management services for smaller programs or individual work streams of a larger program. Our “PMO in a Box” offering includes project plans, project charters, governance and escalation models, communication strategy and plans, issue management, risk management, system deployment, and hyper care models.
Prudentia produces validated computer system solutions. We do it for our systems and we do it for our clients’ systems. Our team of onshore and offshore resources can lead validation streams, author test scripts, dry run scripts, pre-approve scripts, execute scripts, and post-approve scripts.
Our team can also author validation plans, data migration plans, risk assessments, trace matrices, test plans, test summary reports, and validation summary reports. Our team is well versed in GAMP 5 processes supporting FDA CFR 21 Part 11 and EU Annex 11.