Clinical Science & Trial Operations

Pharma IT offers Clinical Science & Trial Operation consulting services to support clinical development programs and trial operations.

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

Pharma IT consultants provide clinical team leadership and operational expertise through collaborative planning, implementation, and execution, whether your project is performed in house or is partly or fully outsourced. The Pharma IT consultants offer flexible support as needed for the individual teams, while ensuring consistency, strategic input and a high standard of quality according to ICH-GCP guidelines and regulatory guidance documents.

Clinical Science & Trial Operations consulting services include:

  • Clinical project management
  • Development of clinical investigational plans and core team support
  • Development of protocols and other clinical trial documents
  • Trial team management and Sponsor oversight for outsourced projects
  • Risk management
  • CRO and vendor management
  • Trial Master File set-up and maintenance
  • Audit/inspection preparation
  • Clinical SOP development

At Pharma IT, we also have teams of skilled Clinical Data Managers, Drug Safety professionals and Medical Writers that can work with our Clinical Science & Trial Operation team if further specialties are needed. Please contact us to discuss, how our team can best support your clinical development program.

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

Meet the Clinical Science & Trial Operations team:

Director, Clinical Science & Trial Operations
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.