Clinical Project 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
- Site selection
- Recruitment strategy
- Organization of investigator meetings
- Budget overview
- Status reporting and ongoing communication with clients
- Risk Management
- TMF Management
- Selection of laboratories and external vendors
- Generation and compilation of submission packages for EC and authorities
- Maintenance of files and archiving