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 stakeholders.

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

Project Support from Phase I to IV

  • Development of Clinical Investigational Plans and Translational Medicine strategies
  • Core Team Support
  • Global Clinical Trial Management
  • Sponsor Oversight, CRO & Vendor Management
  • Development of Clinical Trial Protocols & other Trial Documents
If you need support don’t hesitate to contact us.

Selected Profiles from the Clinical Science & Trial Operations Team

Each of our consultants boasts over 10 years’ experience and holds a vast array of expertise. You can find more detailed information about our team, here.

Functional Support, including cross functional work with other Pharma IT consultants

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. This includes:

  • Trial Master File set-up and maintenance
  • Audit/Inspection preparation
  • Clinical SOP development
  • Medical Writing services
  • Data Management services
  • Statistical Services

Please contact us to discuss, how our team can best support your clinical development program.