Clinical Research

Identify and prioritize financial, technical, and legal risks to ensure project success
Develop contracts and subject enrollment strategies to minimize costs and stay on budget
Utilize proven audit techniques to establish a practical approach for maintaining regulatory compliance
Implement best practices for managing misconduct and fraud to protect patient safety and avoid costly regulatory and legal action
Develop efficient processes for data management and adverse event reporting to streamline compliance requirements
Utilize proven quality control tools to collect and measure performance data and implement process improvements
Develop trial master files / regulatory files – protocol specific

Overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCPs, and the applicable regulatory requirement(s)
To improve quality and promote high standards
To spot and categorize non-compliance and research misconduct/ fraud
Ensures safety of trial participants

Audit clinical trials for adherence to Good Clinical Practice (GCP) regulations and run a compliant and efficient clinical trial
Identify and avoid the consequences of non-compliance, misconduct and fraud to avoid costly delays
Write, implement and update Standard Operating Procedures (SOPs) to establish a solid backbone to your auditing program
Ensure compliance with informed consent requirements
Select and qualify vendors to ensure outsourced services meet regulatory standards
Assist in preparation for and managing regulatory inspections

molecule-CRO