Pharma IT project management

Pharmacovigilance Database

Case reports on adverse reactions associated with medicinal products need to be collected in a central validated database which allows for electronic reporting to authorities in accordance with the E2B standard.

 

We perform case collection, processing and reporting on your behalf using our own pharmacovigilance database.

 

For companies planing to operate their own database, we provide advise on which commercial database provider to chose.

 

We manage your pharmaceutical IT projects!

Combining our long-time experience in regulatory affairs, pharmacovigilance, quality assurance and manufacturing with our excellent in-house understanding of computerised systems and software development, we provide comprehensive guidance during your IT projects.

 

We make sure that management, end users and software developers speak the same language and follow a common strategy.

 

Ensuring a professional project management, we help you 

  • analyse current and future needs,
  • develop an IT strategy and define technical specifications,
  • reach predefined goals with well structured processes.

 

Our services also include:

  • Advice on which software vendor to choose based on our detailed market overview.
  • Advice on good software design with a focus on high usability.
  • Support in designing, developing, validating and maintaining in-house software, e.g. ERP systems and pharmacovigilance databases.
  • Preparing software manuals.
  • Performing in-house user training.
  • Providing pharmaceutical and technical advice on how to implement new requirements, e.g. the ICH E2B(R3) specification for pharmacovigilance case reports.