Excellence in Ensuring Appropriate Study Conduct
Advanced Clinical designs and delivers superior clinical monitoring services with highly skilled CRAs who utilize relevant therapeutic experience, a positive and collaborative approach to site relationships and protocol-specific solutions. Whether your trial is centralized or remote, Advanced Clinical proactively identifies challenges and risks and manages performance to ensure that clinical operations are conducted efficiently and documented properly according to your clinical monitoring plan, from site qualification to study close.
CRA Skills
- An average of 11 years of experience
- One of the industry’s highest employee retention rates (>90%)
- Proficiency with latest industry tools, requirements and methodologies
- Experience creating and deploying clinical monitoring plans
- Trained to manage trials at every stage, regardless of complexity
- Adept at collecting PROs via IVRs, electronic diaries and real-time reports from traditional, hybrid and remote trials
- Global presence and regionally based for easy access to project sites
CRA Expertise
- Site qualification, selection and activation
- Site training
- Plan development
- IP accountability
- Study conduct
- Clinical remote monitoring
- Data lock in collaboration with biometrics
- Study close
Risk Based Monitoring in Clinical Trials
Advanced Clinical deploys a systematic and prioritized approach in our RBM model, involving a formal risk assessment and the generation of a Centralized Monitoring Plan (CMP) and Risk Management Plan (RMP) for each trial. The risk assessment identifies and categorizes areas of risk and provides for the determination of an overall risk level for your trial, and along with the RMP, shapes and guides the optimal clinical monitoring plan for your needs. The specific processes involved in the execution of oversight and monitoring activities (monitoring frequency, type, etc.) are described within the trial project plans (e.g., Project Management Plan, Clinical Monitoring Plan, Data Management Plan).
A high-level overview of this process is provided below.
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