Deskripsi
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
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