Patient Safety Services

We enable our clients to strengthen their Patient Safety and Pharmacovigilance capabilities – from business process support to specialized IT solutions

 

Business Support

Solid, globally harmonized, and efficient process design is crucial for a PV organization

Pharmacovigilance Operations

A lean, risk-based operating model – combining processes, sourcing strategy, and system implementation – is key to a cost-efficient Pharmacovigilance setup.

Technical Implementation & Automation

We support the implementation of lean, automation-enabled Pharmacovigilance solutions that address the complexity of global regulatory requirements.

 

Business Support

Business Processes

  • We help you to design efficient business processes in any new challenges in PV
  • We review your existing business processes to identify areas of improvement or harmonization need
  • We harmonize business processes across headquarter and affiliate functions to improve transparency and efficiency across the organization

Quality Management System

  • Creation or update of quality documents and manuals (e.g. SOP, work instructions)
  • Based on our customer’s needs, we can apply our proven standards or work in the given customer’s framework
  • We review your PV QMS system to identify potential gaps and areas of improvement
  • We specifically pay attention to the hand-over steps between different company functions (e.g. PV – QA – IT) to ensure smooth interaction without any gaps or compliance risks

Business Project Support

  • Any kind of technical implementation project requires a corresponding PV business lead or interface function
  • We provide the project role of a business project lead who acts on behalf of your PV business function to represent and enforce your business requirements in an IT project
  • We develop digital and conventional training concepts, prepare training material and conduct user trainings
  • We create any kind of user documentation such as user manuals, data entry guidelines, hand-outs, etc.

Change Management

  • Change management ensures a smooth roll-out of new processes and tools in the organization
  • We develop change and communication concepts tailored to your PV business organization, based on a thorough stakeholder analysis
  • We support you in preparing and executing the planned change and communication activities

Pharmacovigilance Operations

Compliance, effectiveness, and efficiency form the backbone of modern Pharmacovigilance operations

A lean, risk-based operating model – combining processes, sourcing strategy, and system implementation – is key to a cost-efficient Pharmacovigilance setup.

We provide support in various areas:

  • Definition or re-design of the overall operating model from organizational design to technical implementation
  • Developing a well-balanced outsourcing strategy by making use of external scalability and cost-efficiency while keeping key knowledge in-house
  • Support in implementing and configuring a globally harmonized, efficient, and automation-supported safety database systems

Technical Implementation and Automation

We design and implement safety systems that are simple to operate, easy to manage, and fit for long-term use

Given the complexity of global regulations and the high volume of ICSR reports, a well-designed, efficiently implemented solution delivers significant value.

  • Globally harmonized implementation from ICSR intake to submission Utilization of modern AI technology to automatically extract and translate data elements from multi-language source documents to the automated creation of narratives
  • Rule-based automations and validations to prevent rejected ICSRs during submission
  • Careful integration and automation for countries with local submission specifics (e.g. China, Japan, Korea). From supporting automation (e.g. auto-generation of local narratives) to full automation (e.g. touchless submission for Korea foreign submission)
  • Integration of the systems landscape from Safety-internal connections (e.g. signal management, cumulative reports management) to cross-functional connections (e.g. Clinical, Regulatory, Quality)