Flexible CRO services that produce consistent results

• We currently operate in major cities in India and the USA.
• Access to treatment naïve subjects
• High subject enrollment and retention
• Quick turnaround with subject enrollment
• Timely delivery of high quality data

Clients benefit from continuity in QED's monitoring staff. QED's staff is cross-trained across therapeutic areas giving them added perspective.

QED's monitoring services include:

• Monitoring Study Progress
• Source Document Verification
• Confirmation of Subject Eligibility
• Tracking of Subject Compliance
• Reporting of Adverse Events/Serious Adverse Events
• Regulatory compliance
• Regulatory Documentation

QED is experienced in preparing, executing and managing subject recruitment programs that provide detailed information and reminders to each clinical site and each stakeholder (potential subjects, physicians, the Principal Investigator, etc.) along the way. QED specifically tailors programs based on your objectives and the specific programs to achieve consistent, reliable and qualified enrollment.

TheQED project management team will work with you on all aspects of the trials from the first regulatory submissions through the closeout and final reporting to help you and your project succeed and be on time. QED project managers work effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output.

QED Project Management deliverables include:

• Project Management Plan
• Monitoring Plan
• Safety Management Plan
• Data Management Plan
• Statistical Analysis Plan
• Frequent and timely reports to stakeholders
• Budget Forecasting and Management

QED provides support across the full spectrum of product design and development through regulatory compliance. QED staff will work with you to develop and implement global regulatory strategies, prepare submissions, produce product development plans and manage communications.

QED Services include:

• Strategy Planning
• Regulatory collaboration meetings
• Audit preparation
• Warning letter resolutions

QED performs Quality Assurance audits to ensure quality of the study data. QED staff uses proven procedures and templates. QED takes into consideration your resources and capabilities, develops and implements a program that can withstand audits by regulatory bodies.

QED Quality Assurance services include:

• Adherence to established SOPs
• QA Audits of Clinical Trial Sites
• QA Audits of third party vendors
• Training and Development
• QA of Statistical Analysis Plans
• QA of Final Study Reports
• Internal Audit support