Clinical Trial Project Management

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. Ensuring deliverables are met within budget and on time, our project managers support Phase I-IV clinical trials across a wide variety of therapeutic indications and geographies. Our project managers are regionally based in North America & Europe. 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.

Veristat's project managers are highly skilled, experienced, dedicated and 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, communication 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

Veristat's 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 programmming, data review committees, medical writing and strategic consulting experts.

Case Study

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