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:

Clinical Project and Trial Manager, Senior Pharma Consultant
Birgitte Sloth

Experienced Clinical Scientist, Trial and Project Manager with more than 15 years of experience with scientific, operational and strategic parts of project and trial management, functioning as Global Study Lead and Clinical Project Scientist. Extensive experience with vendor and stakeholder management, protocol authoring, management of clinical trial teams, and clinical project management within early phase clinical development including phase I-II and phase III in a rare disease indication.

Academic background in metabolic disease area and working experience in obesity, diabetes, cardiovascular, immunology, dermatology, respiratory, musculoskeletal and neuroscience disease areas.

Experience within translational medicine, pediatric investigational plans, NDA submission.

Clinical Project and Trial Manager, Pharma Consultant
Berit Grevstad

Experienced international clinical trial manager and site manager from Clinical Research Organizations and Academia.  Experienced in start-up of multinational Phase I – IV clinical trials, including development of trial related documents such as trial protocols, risk management plans, monitoring plans and eCRFs.

Academic background as project manager in infectious disease areas (HIV, Malaria, Ebola) and working experience in infectious diseases, vaccine development, immunology, hematology, oncology, diabetes, cardiovascular, respiratory, and neuroscience disease areas.

Director of Clinical Trial & Operations, Clinical Project and Trial Manager
Maria Wriedt Jakobsen

Senior Clinical Trial Manager and Project Manager with more than 13 years operational and strategic experience with planning, overseeing and managing international clinical trials. Experience with authoring clinical trial protocols, oversight plans, risk management plans including risk-based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings. As well as very experienced with vendor and stakeholder management.

Academic background as Cand. Pharm and working experience in diabetes, hematology, dermatology, neurology, oncology as well as orphan diseases.

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