Clinical Monitoring
From Concept to Closure, Our CRAs can help you!
At CDSS, we have a dedicated team of Clinical Research Associates (CRAs).
Our team of CRAs has a wide range of experience in all phases and many therapeutic areas of clinical research.
All our CRAs monitor the conduct and progress of clinical trials in accordance with CDSS or Sponsor company SOPs, ICH GCP and EU directives.
We can provide both field and site based staff on a full or part time basis.
Our CRAs can provide a full range of clinical monitoring services including:
- Site and Investigator Selection
- Pre-study site assessment
- Ethics applications
- Regulatory applications
- Preparation of Investigator meetings
- Initiation meetings
- Monitoring and report writing
- Adverse Event monitoring
- Query resolution
- Investigational Medicinal Product (IMP) accountability
- Preparation for study site audit
- Maintenance of essential documentation
- Close out visits
