CLINICAL TRIAL MONITORING
Clinical Site Monitoring is a core service of Cedent Research. We provide our well trained, qualified and experienced regionally based Clinical Research Associates (CRAs) who has an average of 1 to 10+ years monitoring experience. Our clinical research associates (CRAs) are focused on early identification and rapid resolution of issues. Our internal experienced CTMs can involve in designing and implementing clinical monitoring plans.
Our clients utilize a CRA or team of CRAs at a given point of time. Clients will also have an excellentoption to choose based on qualification, experience and budget. They can be on board as contractors or full time employees.
Risk Based Monitoring
There is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality. For example, incorporation of centralized monitoring practices, where appropriate, should improve a sponsor’s ability to ensure the quality of clinical trial data.
Several publications suggest that certain data anomalies (e.g., fraud, including fabrication of data, and other non-random data distributions) may be more readily detected by centralized monitoring techniques than by on site monitoring it has been suggested that a statistical approach to central monitoring can “help improve the effectiveness of on-site monitoring by prioritizing site visits and by guiding site visits with central statistical data checks,??? an approach that is supported by illustrative examples using actual trial data sets.
A recent review of onsite monitoring findings collected during a multi-center international trial also suggests that centralized monitoring can identify the great majority of on-site monitoring findings. The review determined that centralized monitoring activities could have identified more than 90% of the findings identified during onsite monitoring visits. Our Trial Management and Monitoring team are experienced in effective risk based monitoring and will produce quality data out comes for your study.( Reference : FDA Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring )
Onsite monitoring cost is a huge section of any clinical trial budget. Increasing cost for conducting a clinical trial has been nightmare for any sponsor company. Remote monitoring is one of the functional service that could be a definite way to cut cost.
- We’re opening up opportunities for office- based/remoteCRAs to play key rollin this business area as Remote Monitors.
- We are recruiting proactive and self-motivated Clinical Research Associateswho has previous monitoring experience with a life science degree looking to advance their career in clinical research.
Remote Site Monitor will perform project site management activities on assigned projects in various countries in accordance with the respective local regulations and guidelines. They will review study data from various sources remotely, collect study documentation and resolve issues/requests outstanding information, and liaise with local CRAs to contact study sites locally.
Main Responsibilities Of Monitor
- Assesses site qualification potential : reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports.
- Participates in the implementation of clinical studies : communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.
- Supervises the conduct of clinical studies : acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, andgood clinical practices; writes follow-up visit reports.
- Ensures the quality of the project : verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.
- Closes clinical studies : verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.
|Excellent Therapeutic knowledge/Experience||Strong Participation in Bid Defense process|
|Excellent Scientific expertise||Ownership of Startup to close out|
|Excellent Qualification and Training||Accountable for timelines and deliverable|
|Excellent Leadership skills to drive results||Manage Budget/Utilization throughout study|
|Experience Managing Global Clinical Trials||Experience Negotiating with vendors|
|Experience in all clinical Phases||Develop Clinical Management Plan|
|Ensures team work to achieve desired results||Write Protocol and other clinical documents|