SERVICES
Flexible clinical operations support, from strategy to execution.
Whether you need interim leadership, stronger vendor oversight, or hands-on study management, Lauth Life Sciences provides the right level of support for your stage of development.
01
Fractional Clinical Operations Leadership
We provide experienced Heads of Clinical Operations, Directors, and Clinical Trial Managers on a part-time or interim basis. We lead your clinical strategy, guide your team, and represent clinical operations to executives, boards, and investors.
02
CRO Selection and Oversight
Choosing the right CRO is one of the most important decisions a sponsor makes. We manage the RFP process, evaluate proposals, negotiate scope and budget, and provide ongoing oversight to keep your CRO accountable to timelines, quality, and cost.
03
Study Start-Up
We accelerate the path to first patient in. This includes feasibility, site selection, contract and budget negotiation, regulatory and ethics submissions, and essential document collection.
04
Trial Execution and Management
We oversee day-to-day study conduct, including enrollment tracking, site performance, monitoring oversight, risk management, and timeline and budget reporting.
05
Vendor Management
Beyond the CRO, we coordinate central labs, IRT, EDC, imaging, and other specialty vendors so every partner is aligned and delivering.
06
Inspection Readiness and Quality
We help you maintain a complete, audit-ready Trial Master File, strengthen SOPs, and prepare your team for regulatory inspections and sponsor audits.
07
Clinical Operations Build-Out
For companies building an internal function, we design the structure, processes, and systems you need, and help you recruit and onboard the right people.
ENGAGEMENT MODELS
Fractional.
Ongoing part-time support on a set schedule.
Interim.
Full-time coverage during a leadership gap or critical study phase.
Project-Based.
Defined scope for a specific deliverable, such as a CRO selection or inspection readiness review.