Clinical Science & Trial Operations
Leading your clinical development program from First in Human to Submission and Beyond
Clinical Science & Trial Operations
Leading your clinical development program from First in Human to Submission and Beyond
We provide exceptional clinical team leadership and expertise to support clinical development programs and trial operations
From trial planning to close-out, our highly skilled clinical science and trial operations team ensures proper trial planning and conduct, while fostering good communication between all stakeholders. We can also support your clinical development plans and project teams from first in human trial to submission, and beyond.
We provide exceptional clinical team leadership and expertise to support clinical development programs and trial operations
From trial planning to close-out, our highly skilled clinical science and trial operations team ensures proper trial planning and conduct, while fostering good communication between all stakeholders. We can also support your clinical development plans and project teams from first in human trial to submission, and beyond.
Our Clinical Science & Trial Operations consulting services include:
- Clinical project management
- Development of clinical investigational plans
- 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
- Audit/inspection preparation
- Trial Master File set-up and maintenance
- Audit/Inspection preparation
- Drug Safety
- Clinical SOP development
- Medical Writing services
- Data Management Services
- Statistical Programming
Each of our consultants boasts over 10 years' experience and holds a vast array of expertise
Our extensive experience uniquely positions us to contribute with specialist perspectives, experience, and advice on your project while ensuring that the tasks at hand get solved and milestones are met.
Our consultants can 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, Pharma IT’s 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.
We are experts in clinical development
Pharma IT can assist you in shaping your clinical development program and global clinical trial conduct – whether your company has chosen an in-house or a partly or fully outsourced solution. Because of our vast experience, we are in a unique position to contribute with specialist perspectives, experience, and advice on your project – all this while ensuring that the tasks at hand get solved and milestones are met.
Trine Stougaard Bak, Director of Clinical Science & Trial Operations