Start up and Regulatory
Start Up
Coordinating start up across multiple countries is challenging and often inefficient.
As requirements become more specialised the number of people involved can be huge. At Clinicology our very experienced clinical research professionals help streamline the interactions so that start up timelines are optimized.
Activities Include:
- Timeline planning and strategy
- Development of study documents (eg ICFs) and translations
- IRB/IEC Submission coordination on country and site level
- Site contract and budget negotiation
- Essential document collection
- Site activation “green light” document review to ensure ICH compliance
Regulatory
Clinicology can support both clinical trial focussed regulatory work and broader strategic discussions
Activities Include:
- Scientific Advice and Regulatory Agency interactions
- European CTA Submissions for clinical trials, CTIMP and Medical Devices
- Facilitate legal representation, UK, Europe, Switzerland
- Production of European required documentation from IND documentation (eg IMPD)