Clinical trials involve several of your company’s stakeholders, including Clinical Research Organisations (CROs) and other vendors. Those stakeholders depend on having the correct decisions taken and communicated at the right time.
Unplanned delays and/or failed risk assessment in the trial may lead to increased costs and/or reduced quality that can result in regulatory approval failure in the future.
Our clinical project management services
Our project management team facilitates the path to completed trials where company resources and expertise are limited. We assure a correct focus through a tight collaboration with your selected CROs, vendors, and company stakeholders.
- We lead cross-functional study teams, both internal and external, to ensure delivery per plan, along with communicating with company stakeholders.
- Being responsible for planning and timeline adherence.
- CRO and vendor management, including procurement, contracting, and oversight.
- Create and implement sponsor-level management plans (risk management and sponsor oversight plans) and review CRO study management plans (monitoring and safety management plans)
- Participate in study feasibility activities, including site qualification and site initiation visits.
- Writing clinical study synopsis and clinical study protocol, including amendments.
- Performing quality review of study documentation such as status reports, trial master files, and monitoring reports.
- Perform audits and participate in inspections, as well as support with issue resolution if needed.
We understand the importance of staying on time, and within budget, so we work closely with you to develop a customized project management plan that meets your unique needs and goals.
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