Successful clinical trial management pivots around the project manager – the strategic and pro-active thinkers who manage the study timeline, plan for risk mitigation, and overcome the challenges that arise.
We manage your clinical trial and regulatory submission projects from start to finish. Our project managers support Phase I-IV clinical trials across a wide variety of therapeutic indications and geographies, ensuring deliverables are met within budget and on time. Our project managers are regionally based in Asia, Africa, Australia, and New Zealand. All project management activities are conducted in compliance with the study protocol, project management plan, standard operating procedures, ICH-GCP, and all applicable regulations and guidelines.
Grand Pacific CRO’s project managers are highly skilled, experienced, dedicated, and will integrate seamlessly with your team in order to deliver high quality, effective and decisive project management support. We offer the following:
- Development of Project Management Plans including communication, training, risk mitigation and escalation procedures
- Identification and arrangement of study-specific training for the project team
- Proactive continual risk identification, assessment, mitigation, and contingency
- Development and maintenance of timelines
- Project ownership from contract award to final contract deliverable
- Oversight of the scope of work and budget with early identification of change orders and monthly forecasting
- Support of site and sponsor personnel
- Oversight of study vendors including contracting and ongoing maintenance
- Oversight of clinical database development and maintenance
- Quality Control, maintenance, and archiving of required study documentation
- Closure of trials, including site closeout and decommissioning of the EDC system
Our project managers coordinate with all of the integrated teams and functions who collaborate and work together throughout the clinical trial or regulatory submission project including: monitoring, biostatistics, data management, SDTM standards conversion, SAS programming, safety data review committees, and medical writing.