Fractional Clinical Operations
Not every biotech can – or should – build a full internal Clinical Operations team in the early years. BaseBio’s fractional model gives you access to Senior Clinical Operations leadership on a flexible basis, so you can design and run studies with confidence while keeping your burn rate under control.
Fractional Head of Clinical Operations
BaseBio provides fractional Head of Clinical Operations leadership, delivering senior expertise without the commitment of a full-time role. We provide strategic oversight, active CRO management, and accountable decision-making to ensure clinical programs progress efficiently, compliantly, and in line with ICH GCP (R3) sponsor responsibilities.
Clinical Operations Consultants to Support Delivery of Your Clinical Trials
BaseBio’s fractional clinical operations consultants integrate seamlessly with your team to support high-quality trial delivery and effective CRO oversight. Our hands-on support maintains momentum, transparency, and regulatory compliance across all stages of your study, while ensuring sponsors retain visibility and control.
Trial Planning and Implementation
We lead end-to-end trial planning, translating protocol objectives into executable operational plans, timelines, and CRO and vendor strategies. From feasibility through start-up and execution, we ensure trials are implemented efficiently, with clear roles, governance, and oversight aligned to ICH GCP (R3).
Risk Management and Crisis Handling
BaseBio proactively identifies operational, regulatory, and CRO-related risks before they impact timelines, quality, or budgets. When challenges arise, we provide calm, decisive leadership to manage vendors, resolve issues, and protect trial integrity and sponsor accountability.
Leadership, Guidance and Motivation
As fractional clinical operations leaders, we align internal teams, CROs, and vendors around clear priorities, governance frameworks, and delivery expectations. We bring structure, accountability, and motivation to clinical teams, particularly during periods of growth, transition, or increased regulatory scrutiny.
Support Sponsor Oversight for ICH GCP (R3)
We support sponsors in meeting evolving ICH GCP (R3) expectations by embedding robust oversight, risk-based quality management, and clear accountability frameworks. This approach ensures sponsors maintain control and visibility across CROs and vendors while remaining inspection-ready.
Support Substance / “Boots on the Ground” in Australia for R&D Tax Requirements
BaseBio provides genuine substance in Australia through experienced fractional leadership actively overseeing clinical activities. This local, hands-on presence supports R&D Tax Incentive requirements by demonstrating real decision-making authority, operational control, and execution within Australia.
CRO & Vendor Selection and Oversight
Vendor Identification and Connection
BaseBio leverages deep, on-the-ground knowledge of the Australian clinical research landscape to identify and connect sponsors with the most appropriate CROs, sites, and specialist vendors. Our local presence and independent, experience-led approach ensure vendors are not only fit-for-purpose, but capable of delivering within Australian regulatory, operational, and budgetary realities.
Request for Proposal and Bid Defense
We manage the end-to-end RFP process with active, hands-on oversight, from scope definition and vendor briefing through proposal evaluation and comparison. BaseBio leads bid-defence meetings with practical, local insight—challenging assumptions, interrogating costs, and ensuring sponsors select vendors with confidence, transparency, and accountability.
Accelerate Your Clinical Trial with Streamlined Processes
BaseBio accelerates clinical trials by implementing streamlined, fit-for-purpose processes informed by hands-on execution in Australia. Clear governance, defined decision pathways, and active, boots-on-the-ground oversight reduce delays, improve coordination across CROs and sites, and enable faster, more predictable trial delivery.
Operationalise Your Strategic Vision and Guidance
We translate strategic intent into executable clinical plans grounded in practical delivery and local market knowledge. With experienced leadership embedded in Australia, BaseBio bridges strategy and execution to ensure clinical programs move forward with clarity, alignment, and sustained momentum.
Subject Matter Experts in Clinical Research
By leveraging our subject matter expertise, vendors in clinical trials, biotech, and venture capital can gain a competitive edge in their respective industries. We offer specialized knowledge, insights, and guidance to help vendors optimize their operations, align their services with industry trends and regulatory requirements, and effectively cater to the needs of their clients in these specialized fields.
Support Vendors with Clinical Trials Expertise:
We understand the unique challenges and requirements faced by vendors operating within the clinical trials landscape. Our subject matter experts possess extensive knowledge of clinical trial processes, regulations, and best practices. We offer valuable insights to vendors, helping them navigate the intricacies of the clinical trials ecosystem and optimise their operations to better serve their clients.
Partner with us to benefit from our comprehensive range of services and specialized subject matter expertise tailored for vendors in clinical trials, biotech, and venture capital. We are committed to empowering vendors to excel in their domains and contribute to the advancement of these industries.
Finance and Directorship
Entity Setup and Sponsorship Services:
We work with financial teams to support administrative aspects of your project, such as entity setup and sponsorship, which can be time-consuming and complex. We handle these processes efficiently, allowing you to concentrate on the core aspects of your project's development.