Detailed overview of Services
We tailor our services to your needs
Project Management &
Vendor Oversight
From hands on to oversight management
Whether you need experts in managing a study end-to-end or just parts of it - we are fully flexible. Services can include in example:
-
Feasibility and Site Selection
-
Start-up Activities
-
Document Development (e.g. Protocol, Monitoring Plan, Quality Management Plan)
-
Project Management Ph I-IV
-
Oversight of Vendors
-
Quality Management (e.g. Site Quality Assessments)
Prior to project start, clear targets and milestones are defined. A RACI can be supportive to define roles, responsibilities and communication paths.
Quality Management,
Audits & inspections
Audit and inspection support in preparation & conduct
Managing inspection or audit readiness alongside daily business operations can be highly challenging. We support you with expert guidance, an independent perspective, and hands-on experience to ensure you are thoroughly prepared and confident for inspections and audits.
Following an inspection or audit, we also support you with CAPA development, implementation, and sustainable follow-up actions to ensure long-term compliance and continuous improvement.
Clinical Operations Processes,
Continuous Improvement
Improved oversight and efficiency
We ensure quality is embedded from the outset in accordance with ICH E6 (R3) guidelines. Drawing on extensive experience within leading pharmaceutical companies and CROs, we specialize in clinical operations process design and SOP development, helping smaller Biotechs to establish robust, compliant processes that ensure effective vendor oversight, operational excellence & inspection readiness.