Consulting Services

Project Oversight Services

 

HighPoint Solutions team of consultants will work with project managers, sponsors and stakeholders during the course of a long or medium term project to ensure that the project is still relevant within the business and regulatory framework of the company. We will ensure that the project requirements map correctly and optimally to the project’s overall business objectives.

A project financial model can be prepared and analyzed to determine if the value of the business objectives are worthy of the current and on-going costs of the project and its resulting organizational, technical and functional changes.

Our consultants are also experienced in using project management techniques to provide companies with a determination of the overall project management quality and project control.

 

Compliance Services

 

HighPoint’s Pharmacovigilance Practice can help companies ensure their systems and business processes are implemented and managed in compliance with all applicable regulations (including 21 CFR Part 11, EMA and ICH guidelines). We can perform system and process audits of vendor supplied and legacy systems, and provide assistance in addressing any compliance issues that are found.

Additionally, we can work with companies to develop SOPs and implement compliant processes for information technology and safety data management, SAE reporting, clinical data reconciliation, backup and restore, disaster planning and recovery, IT change management and many others.

 

Appian BPM Life Sciences Solutions

 

HighPoint’s Pharmacovigilance Practice as an Appian partner is to provide Appian BPM services to life science organizations. Our service offerings include business process consulting, Appian BPM application development, and an integrated product safety workflow within Oracle Argus Safety.

Our dedicated business process consultants and engineers work closely with the Appian Professional Services team from initial phase of business process analysis and design through the successful deployment of Appian applications.

Our Appian BPM services include:

  • Business Process Optimization in Medical Product Safety, Regulatory Affairs, Labeling, and Clinical: Business Process Analysis and Evaluation, Process Model Design, STAR Methodology
  • Appian BPM Applications: Planning, Development, Integration, Validation, Deployment, Support
  • Safety Workflow Automation: Case Triage and Review, Automated Follow-up, Case Management, Clinical Case Monitoring, Medical Review and Assessment

 

Click here to download!