Enabling technologies

We are Subject Matter Experts (SME) in all EDM topics with a long experience in selecting and implementing enabling technologies in large and small companies. We help our clients with assessing, selecting and deploying technologies such as:

• Electronic Document Management 
  
• eTMF Management Tools
  
• eCTD Publishing Tools
  
• Structured Content Authoring
  
• Clinical Trials Tracking Systems
  
• e-adjudication
  
• Risk-based Monitoring
  

For software vendors  

We offer packaged support for the implementation of EDM solutions on behalf of the software vendors.

• Sponsor business process review
  
• Sponsor system maturity assessment
  
• Sponsor content mapping to DIA reference models (Regulatory, TMF, GMP…)
  
• Sponsor training (using vendor training material)

For sponsor companies

We offer several packaged support solutions at a fixed price to pharmaceutical, biotechnology and medical device companies wishing to select and implement an EDMS for clinical, regulatory or quality documents.