Clinical trial monitoring and training are part of Symbiorph Clinical Trialogy clinical trials services. Great results require great commitment. To maximize our monitor's ability to focus on clinical study, SCT's has highly skilled clinical monitoring team who display professionalism and innovative problem solving skills. Our clinical monitoring team has thorough knowledge in ICH-GCP guidelines and local and international regulatory requirements.
Our clinical monitors (CRA's) were carefully selected for their therapeutic expertise which helps in maximize flexibility, create an efficient and cost-effective monitoring process.
Clinical monitoring services include but not limited to:
- Site Qualification, Initiation, and Close-Out
- Training site staff and investigators
- Monitoring Plan Development (Including frequency, intensity, and activity)
- Organizing Investigator Meetings
- Interim Site Monitoring
- Clarifying inclusion/exclusion criteria with the investigator
- Protocol Waiver and Compliance Assessment
- Reporting serious adverse effects to the sponsor and to the applicable regulatory authority
- Source Document Verification
- Regulatory Document Review and Collection
- Investigational Product Accountability
