Our SOPs are as per the standards required by ICH GCP ,New Clinical Trial Rules, 2019, quality of every aspect of the trial is maintained. Our SOPs ensure quality of the data collected, thereby improving the science of the study.
Our SOPs describe:
Excellent training source for new employees and/or fellows.
Monitor site performance, which includes from site initiation to closeout.
Our SOPs are as per standards required by ICH GCP , quality of every aspect of the trial is maintained.
Our SOPs work as per the ICH GCP, and institutional policies to protect the rights and welfare of human study participants.
Our SOPs ensures quality of the data collected, thereby improving the science of the study.
Flow of Documentation from Preparing and Submitting to Ethics committee, Submitting Amendment to Ethics committee, Establishing and Training the Clinical Study Team, and Delegating Responsibilities.
Establishing Source Documents.
Study Subject Recruitment Plan and Risk Management Plan.
Contacting and Scheduling Potential Study Subjects for an Initial Visit.
Obtaining Informed Consent from a Potential Study Subject.
Enrolling and Recording a Subject data
Medical Writing & Medical Monitoring.
Monitoring Subject Compliance During a Study.
Database Quality Plan.
Quality Control and Quality Assurance .
Data management system and SAP.
Conducting Investigator Meeting.
Responding to a Clinical Hold Order.
Likewise Ardent will ensure the quality of the activities.