Dietrich Biopharma Consulting is a consulting firm that specializes in assisting both startups and established companies in improving patient outcomes by utilizing a patient-centric focus for the design and implementation of their studies.

By focusing on clinical program strategic design, planning, and operational oversight we hope to help companies speed the delivery of important products to patients and support appropriate market access and utilization.

Dietrich Biopharma Consulting has the expertise and is ready to support you through every step of the study process, including the following areas of focus:

Evidence generation planning
Clinical program and study design
Operational planning
Program management
Feasibility
Country and site selection
Applications of innovative approaches, including:
- Adaptive designs
- Platform trials
- Digital health technologies
- Real-world data and real-world evidence (RWE)
Clinical development operations / trial management
Authoring of study concepts, protocols, informed consent forms, charters, manuscripts
Planning and organizing steering committees, data monitoring committees / data safety monitoring boards, data review teams, and patient and opinion leader advisory boards
Quality-by-design
Design thinking
Risk management
Development and collection of Clinical Outcome Assessments (COAs): Patient-reported Outcomes (PROs), Clinician-reported Outcomes (ClinROs), Observer-reported Outcomes (ObsROs), Performance Outcomes (PerfOs)
Oversight of CROs and vendors
Stakeholder alignment
Staff supervision, coaching and mentoring
Patient-focused drug development
Patient engagement
Partnering and co-designing with patients and carers
Continuous process improvement