PROMETRIKA’s experienced team provides comprehensive clinical trial management services. We enhance the success of trials and programs by working collaboratively with our sponsors, anticipating challenges, and managing trials proactively. Our superior global and local regulatory knowledge, strong relationships with investigational sites and medical experts, and highly experienced cross-functional teams enable us to deliver world-class clinical trials powered by cutting-edge technologies.
PROMETRIKA’s global clinical trial managers oversee the timely initiation of clinical trials, including global feasibility assessments, site and vendor selection, risk management planning, subject recruitment and retention strategies, and enrollment projections. Throughout the conduct of trials, we provide real-time reporting metrics to manage enrollment progress and monitor site expectations, activity and performance.
Trials are monitored centrally as well as by clinical research associates (CRAs) at the clinical sites, based throughout the world and matched to the protocol requirements in indication and experience. Utilizing regional, seasoned professionals and, if requested, remote monitoring and targeted source document verification, PROMETRIKA maximizes cost efficiency in the conduct of these trials.
- Worldwide Study Feasibility Assessment
- Investigator Identification & Selection
- Subject Recruitment and Retention Strategies
- Enrollment Projections & Management
- Site Contract & Budget Negotiations
- Investigator Payment Administration
- Vendor Selection & Management
- Clinical Monitoring Plan Development
- Informed Consent Form Development
- Trial Master File Creation & Maintenance/Regulatory Document Management
- Regulatory and Site/ IRB Submission Management
- Investigator Meeting Coordination
- Risk Management
- Comprehensive & Risk-based Monitoring compliant with ICH E6 R2
- CRA Management and Quality Control
PROMETRIKA’S CLINICAL OPERATIONS TEAM - A SNAPSHOT
- Average of 10 years of experience
- Experienced in major therapeutic areas including oncology and rare diseases
- In-house and regionally based throughout the world