- We are collaborative and consultative, yet acutely focused on a core set of therapeutic areas.
- By partnering with Cliniserve, you will work with some of the most qualified scientists in the clinical research industry.
- We have deep understanding of key therapeutic areas to help you acuminate your strategy through all stages of your trial.
- Our team of therapeutic and medical experts has extensive experience with global, pivotal Phase I-IV studies monitoring across multiple indications and is focused on helping your trial is monitored proactively.
- We develop risk based monitoring plan for your clinical trials.
What is Risk-Based Monitoring?
- Risk-based monitoring is the process of ensuring the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study. Guidance from the US Food and Drug Administration (FDA) outlines three steps in a risk-based approach to monitoring:
- Identify critical data and processes. To accurately monitor the quality of a study and the safety of its participants, the sponsor must know which elements are most important for each particular study – from informed consent to eligibility screening and tracking of adverse events.
- Perform a risk assessment. A risk assessment involves determining specific sources of risk and the effect of study errors on those risks.
- Develop a monitoring plan. According to FDA’s guidance, a monitoring plan should “describe the monitoring methods, responsibilities, and requirements of the trial.” The plan is responsible for communicating risks and monitoring procedures to everyone involved in monitoring the trial.
We perform below listed monitoring visits during clinical trial,
- Site Identification Visit
- Site Qualification Visit
- Site Initiation Visit
- Interim Monitoring Visit
- Close-out Monitoring Visit