Services

- On-site Monitoring (no limits on travel)​ - Passports Ready

- CRO CRA Oversight, Sponsor CRO Oversight (Metrics, Report Reviews, On-site Assessment Visits, etc.)​ ​Patient Profiles/Data Listings Review (AE, SAE, PD, Query, ET, etc.)

​- Vendor Management/Oversight and Audits, Creation and Management of CAPAs Creation/editing Monitoring Visit Reports, Annotated Trip Reports, Clinical Monitoring Plan, Source Documentation, Newsletters, Clinical SOPs, etc. 

- Principal CRA / Study Lead / Lead CRA / Senior CRA Clinical Research Audits/ GCP and/or QA Audits

- To assist sponsors and CRO companies in all areas of clinical research. To bring to the table the answers and solutions to not only solve difficulties that arise during the set-up, duration and closing of any study, but to collaborate with the company to take lessons learned and be proactive and adjust the process to make the next study flow smoothly. 

- To implement the start-up process of a study so that fewer issues arrive during the study. For example, the Feasibility Questionnaire and Site Evaluation Visit should be detailed in specific areas to prevent problematic sites and study issues.

- To be an ambassador with the different departments within the sponsor company to create a smoother flow between them. I have seen firsthand that sometimes there is a gap between the QA department and the Clinical Operations team and with effective communication and processes in place I believe it would prevent a lot of issues. 

- Adjust the metrics to evaluate CRA performances that actually measure accomplishments during the on-site or remote visits instead of just days on-site. 

- Recommendations for small adjustments in sponsors tools that would produce better time management, remote capabilities and allow lower paid employees to perform certain monitoring task with remedial cost which would produce an overall savings to the sponsor. ​