Clinical Trial & Operations

Pharma IT offer Clinical Trial & Operation consulting services to support clinical trial and operation.

From start-up to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between all stakeholder.

Pharma IT consultants provide leadership and operational expertise through collaborative planning, implementation, and execution as well as ensuring consistency, support, and a high standard of quality, meeting ICH-GCP guidelines.

Clinical Trial & Operation consulting services include:

  • Clinical Project Management
  • Development of clinical Investigational plans
  • Development of clinical trial documents
  • Sponsor oversight
  • Risk management
  • KOL engagement
  • Audit preparation
  • Clinical SOP development
  • Third-party vendor management
  • Trial Master File set-up and maintenance
  • Clinical trial management system

 

If you need support don’t hesitate to contact us.

Meet the Clinical Trial & Operation team:

Senior Pharma Consultant
Berit Grevstad

Clinical Trial Specialist with more than 10 years experience with development of study specific documents relevant for the conduct of a clinical trial and obtaining regulatory approvals. Contract negotiation, Qualification, risk assessment & management, Initiation, conduct, and termination, ensuring proper documentation

Director of Clinical Trial & Operations, Clinical Trial & Operations Consultant
Maria Wriedt Jakobsen

Experienced Clinical Trial Manager and Project Manager with more than 10 years of experience in planning, running and managing all phases of international clinical trials. Experience with writing protocols, oversight plans, risk management plans including risk based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings. Experience with setting up laboratories, eCRFs etc. and experience with vendor and stakeholder management.

GCP, ICH GCP E6 R2, GCP monitoring, Project Management, Change Management, Outsoucing of clinical trials, Observational studies, RA M8: Clinical Development and Documentation