Clinical Project Management

Clinical Trial Management

With its extensive dermatological knowledge bioskin is dedicated to supporting your project from the earliest stages of development through to regulatory approval. Whereas our internal team is focused on clinical affairs and regulatory support, we have a network of highly experienced formulation, non-clinical experts and key opinion leaders to round out the development team.

Our project managers can help ensure that critical project milestones are achieved within scheduled time frames and budget by effective coordination and communication between all project stakeholders.

Our services include:

  • Planning of resources and logistics
  • Coordination of interaction between team members
  • Organization of investigator meetings
  • Budget overview
  • Status reporting and ongoing communication with clients
  • Investigator selection and recruitment
  • Training of team members and monitors
  • Selection of laboratories and external vendors
  • Clinical Trial Application (CTA) submission
  • Submission for ethical approval
  • Organization of investigator meetings
  • Supervision of monitors
  • Maintenance of files and archiving