Project management

Pharmnet with its project oriented approach is able to deliver the required outcome of the projects within the ultimate quality, for the reasonable budget and mostly within the required time. Professional level of Pharmnet project managers is guaranteed by their experience in clinical research, particularly at different positions in the past and, for some of them also by certification according to the IPMA standards to C or D level respectively.

Every project is handled by the dedicated team of professionals. Project Manager, as a team leader, is responsible for the whole project. In typical clinical trial, it means from the feasibility phase, via regulatory approvals, management of the contracts, through the monitoring phase up to the data management processes, statistical evaluations and finalization of the Clinical Study Report.

Pharmnet puts a special focus on the implementation phase of the project since the initial phase is understood across the whole company as one of the most important ones. Project Management SOPs require from broad spectra of the available tools defined in Pharmnet quality system at the beginning of the project at least detailed definition of the project scope (with respect to the timelines, quality and budget), preparation of the Risk Management plan, preparation of the Communication plan and preparation of the Milestones plan. Then, the project status is regularly evaluated by the company management and corrective actions are implemented immediately once the deviation from the initial plan is identified. The claim management process is an integral part of the company quality system providing immediate feedback to the company management if anything may be improved.
An online collaborative platform customized to a specific project combining trial management system, electronic trial master file, IXRS, eCRFs and reporting in one place can be deployed in cooperation with our partner. This platform enables all required stakeholders (including Sponsor) to access any needed information in real-time and make appropriate decisions and manage the project efficiently. The system does not require installation and is 21 CFR part 11 compliant.

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