Clinical Research

1. Site Selection

  • Principal Investigator and Site Selection
  • Feasibility Studies and Sites Qualification
  • “Fast-track” Site Activation – Timelines and Scenarios
  • Informed Consent Form (ICF) Preparation and Review
  • Insurance Agreements

2. Project Management

  • 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

3. Clinical Site Monitoring

  • 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

4. Quality Assurance/Auditing

  • 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

5. Data Management / Statistics

  • Data management plan
  • CRF designing and completion guidelines
  • Data entry
  • Statistical Analysis

6. Medical Writing

  • Protocols
  • Investigator’s Brochures
  • Nonclinical Study Summaries
  • Clinical Study Reports
  • Informed Consent Documents
  • Literature Reviews
  • Presentations
  • Articles

7. Training

  • A complete ICH-GCP training program for Investigators and Study Team
  • A comprehensive Human Research Protection Training Program for IRB / IEC
  • Protocol specific training
  • Training on documentation and CRF completion

8. Post-Approval Studies Support