• Careers
  • Events
  • Library
  • Global Reach
  • News
logo-small.png
  • Why Veristat
    • About Us
    • Our Approach
    • Our Leadership
    • Success Stories
    • News
    • Locations
    • Careers
      • Open Positions
      • Core Values
      • Explore Benefits
      • Grow Your Career
      • Because We Care
      • Why Veristat
  • Therapeutic Areas
    • Oncology
    • Infectious Disease
    • Endocrine/Metabolic
    • CNS/Neurology
    • Cardiovascular Disease
    • Coronavirus
    • More Therapy Areas
  • Solutions
    • Cell and Gene Therapies
    • Virtual Trials
    • Rare Diseases
    • Rescue Trials
    • Vaccine Trials
    • Full Service
      • Clinical Trial Planning
      • Clinical Trial Conduct
      • Regulatory Submission
  • Services
    • Full Service
      • Clinical Trial Planning
      • Clinical Trial Conduct
      • Regulatory Submission
    • Strategic Consulting
      • Adaptive Designs
    • Regulatory Affairs
      • Regulatory Consulting
      • Marketing Applications
      • Agency Meetings
      • Regulatory Publishing
    • Clinical Operations
      • Project Management
      • Monitoring & Site Management
      • Patient Recruitment
      • Patient Retention & Site Engagement
    • Medical Affairs
      • Clinical Trial Safety
      • Data Review Committees
      • Medical Monitoring
    • Medical Writing
    • Biometrics
      • Data Management
      • Biostatistics
      • Statistical Programming
      • Standards Implementation
    • Pharmacovigilance
  • Knowledge Base
    • Library
    • Blog
    • Webinars
    • Success Stories
    • Newsletter
  • Contact Us
  • RFP

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.


Managing the Clinical Trial or Regulatory Timelines 

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
collaboration_image_handsoverpapers_opt1024px
  • 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.

 

 

 


Learn More with These Resources

Webinar Presentation
Webinar: Virtual Trial Planning Lessons Learned

Get the webinar presentation to see lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials' ...

open
Webinar Video Replay
Webinar Replay : Virtual Trial Planning Lessons Learned

View the on-demand webinar to see lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials' ...

watch
Infographic
The Time for Virtual Clinical Trials is Now

Download the infographic to learn how virtual trials are defined, the tool kits required to run a virtual trial, examples of what the patient experience can look ...

download
Contact Us
Request A Proposal

Get Updates

  • Why Veristat
    • About Us
    • Our Approach
    • Our Leadership
    • Success Stories
    • News
    • Locations
    • Careers
  • Therapeutic Areas
    • Oncology
    • Infectious Disease
    • Endocrine/Metabolic
    • CNS/Neurology
    • Cardiovascular Disease
    • Coronavirus
    • More Therapy Areas
  • Solutions
    • Cell and Gene Therapies
    • Virtual Trials
    • Rare Diseases
    • Rescue Trials
    • Vaccine Trials
    • Full Service
  • Services
    • Full Service
    • Strategic Consulting
    • Regulatory Affairs
    • Clinical Operations
    • Medical Affairs
    • Medical Writing
    • Biometrics
    • Pharmacovigilance
  • Knowledge Base
    • Library
    • Blog
    • Webinars
    • Success Stories
    • Newsletter
  • Careers
    • Open Positions
    • Core Values
    • Explore Benefits
    • Grow Your Career
    • Because We Care
    • Why Veristat
  • Privacy Policy
  • ©2006 - 2021 Veristat, LLC. All rights reserved. Veristat is a trademark of Veristat, LLC. All other trademarks are the property of their respective owners.