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

Our offer to 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)

Our offer to 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.


 


Package 1, RFP: In just a few weeks, we guide you through the entire process to the final tool selection for a fixed price with no surprises.


  • Educational presentations
  • Systems maturity assessment
  • RFP selection process based on Pocket EDMS specifications          




Package 2, System deployment: We assist you in adapting the selected technologies and optimising your business processes 


  • Business process assessment
  • Content assessment
  • Content mapping and system adjustments
  • Deployment and user training




Package 3, Deployment & Support (yearly subscription allows to even the cost over time): We will setup your new system, train the users and serve as remote administrators taking all the technical burden off your shoulders with an affordable yearly subscription.


  • Content assessment and mapping (initial)
  • System deployment and training (initial)
  • System adjustment and training (continuous)
  • System administration on behalf of the sponsor and level 1 support (continuous)