Program management, site monitoring and audit preparation

Careful program management, site monitoring and detailed audit preparation are essential to protect the safety and rights of clinical trial participants, and the authenticity of your trial’s data. Both processes must also be underpinned by rigorous protocols to achieve best practice quality standards. Empirical Clinical Solutions provides short to medium term support that helps ensure your clinical data is ethical, scientific and achieves regulatory requirements. Benefit from an integrated work package that comprises project strategy, oversight and management including feasibility, site evaluation, patient recruitment and retention strategies, monitoring, training, study close-out and preparation of the final study report.

Our approach helps to:

• identify key opinion leaders, qualification of clinical investigators, clinical vendors and establishment of scientific advisory boards
• liaise with other key functions including regulatory, quality, design, statistical support, e-CRF development, data management
• support and review of the design of the Clinical Investigation Plan, eCRF and all study documentation in collaboration with the study lead
• coordinate the study document approval process including the submission of regulatory and ethical documentation
• prepare and host external liaison with KOL’s/PI’s and collaborative groups
• Support patient recruitment, including ongoing training and monitoring activities.
• develop a calendar for monitoring quality indicators/quality checks (QC) and provide routine reporting of variances to the appropriate Clinical Quality Assurance (CQA) staff and operational leadership
• develop and maintain relationships with investigator site and other departments
• advise on clinical process enhancements based on best experience/best practices, clinical knowledge and gaps in the current clinical strategy
• coach cross-functional project teams on clinical strategy to inform key project decisions and prepare and support audits/inspections
• coach and mentor teams and conduct and develop training programs that contribute to capacity building (e.g., ISO14155-GCP for medical device clinical investigations)
• empower research staff through education in quality improvement methods

Have confidence in your study outcomes with program management, site monitoring and audit preparation support from Empirical Clinical Solutions.

Get in touch today to find out how we can help you.