Project management


Project management

In project management, the building blocks planning, budgeting and implementation of your trial contribute essentially to your project being successful, regardless of whether your project stems from the industry or from the academic environment. Right from the start, our project managers develop an effective and cost-efficient strategy together with you. We know the sequence in which decisions have to be made and will advise you accordingly. After planning and designing the trial and after creating the essential study documents, we will initiate the necessary steps to obtain approval of your trial. During the course of the project we will act as your contact person, coordinate services and vendors as well as monitoring activities, monitor the budget, ensure compliance with the requirements laid down in ICH-GCP and other regulations, and keep an eye on the trial deadlines. In short, we act as your right hand and are ready to offer you advice at all times.

Take advantage of our extensive experience in the field of project management for your comprehensive or individual solutions:

  • Study planning with regard to budget, milestones and project tasks
  • Selection and involvement of vendors
  • Contract management
  • Training of all parties involved (study-specific induction, ICH-GCP)
  • Maintenance of the trial master file
  • Organisation and implementation of investigator meetings
  • Continuous monitoring of goals to be achieved
  • Writing of regular status reports
  • Quality assurance measures

Project management

Our project managers support you in planning, budgeting and implementing your project. Right from the start, the project management team develops an effective and cost-efficient strategy together with you, regardless of what kind of non-interventional study your trial is. During the course of the project we will act as your contact person, coordinate all activities, monitor the budget, ensure compliance with the quality standards and keep an eye on the study deadlines. In short, we act as your right hand and are ready to offer you advice at all times.

Take advantage of our extensive experience in the field of project management for your NIS:

  • Project planning with regard to budget, milestones and tasks
  • Contract management
  • Training of all parties involved (study-specific induction)
  • Continuous monitoring of goals to be achieved
  • Writing of regular status reports
  • Quality assurance measures

Project management

The building blocks planning, budgeting and implementation of your trial contribute essentially to your project being successful, irrespective of how your medical device is classified. Right from the start, our project management team develops an effective and cost-efficient strategy together with you. We know the sequence in which decisions have to be made and will advise you accordingly. After planning and designing the trial, obtaining the CE mark (if not already available), and after creating all essential documents including the technical documentation, we will initiate the necessary steps to obtain approval for your trial. During the course of the project we will act as your contact person, coordinate services, ensure vigilance, monitor the budget, ensure compliance with the requirements laid down in ISO 14155 and other regulations, and keep an eye on the trial deadlines. In short, we act as your right hand and are ready to offer you advice at all times.

Take advantage of our extensive experience in the field of project management for your comprehensive or individual solutions:

  • Study planning with regard to budget, milestones and project tasks
  • Selection and involvement of vendors
  • Logistics, technical support
  • Contract management
  • Training of all parties involved (study-specific induction, ISO 14155 and other regulations)
  • Continuous monitoring of goals to be achieved
  • Writing of regular status reports
  • Quality assurance measures