A rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrollment rate and therefore successful planning of trial milestones is impossible, which in turn compromises the success of the trial.

Working closely with clinical trial sponsors, ClinQuestAdria identifies countries and investigative sites in region well known for their prevalence of the targeted indication. In parallel, team also review regulatory requirements and timelines for each country to ensure country and site approvals will adhere to overall project timelines. We work with only sites with proven track and reliable to deliver enrolment target within timelines agreed with high data quality and integrity.

All about keeping your project on track, on-time and within budget.

We understand the need of many clinical trials sponsors to have medically qualified clinical research experts leading various aspects of their clinical research.

ClinQuestAdria team have many years of clinical and industry experience in various therapeutic areas who are able to provide service and/or oversight:

• Medical Oversight Plan
• Subject eligibility verification
• Protocol Deviations Review
• Adverse Event and Serious Adverse Event review and reporting

We use knowledge, clinical and industry experience to pre-identify risks and challenges in recruiting patients and their retention throughout the study. We build comprehensive recruitment plan and strategies, developing recruitment materials and keeping sites interested into the study by keeping close contacts and discussion throughout the study.

Team ensure completeness, accuracy, high quality and inspection readiness of Trial Master File (TMF) at any time.

Remote data review in the EDC within 15 days of data entry by the site to ensure data completeness and consistency with to identify any concerns with patient safety, data quality and integrity.

ClinQuestAdria team have many years of clinical and industry experience in various therapeutic areas who are able to provide service and/or oversight:

Develop Quality Oversight Plan

Protocol Deviation and Monitoring Visit Issue Trend Review and developing Corrective and Preventive Action Plan and recommendations to study team