Clinical Operations Expertise for Early-Phase Clinical Trials
Biotech Biz provides independent clinical operations services to small biotech companies running early-phase (Phase I/II) clinical trials - from operational planning and partner selection to CRO/vendor oversight, risk management and study delivery.
For a small team running its first or second study, clinical trial execution requires the right operational strategy, planning, oversight and governance, continuous visibility, and early identification of the risks that can impact patient safety, data integrity, timelines, budget and the value-inflection points.
Protect your clinical trial — and the company milestone riding on it — from avoidable risk
We provide specialist clinical operations services across:
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Operational strategy and delivery planning informed by experience across early-phase studies
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Trial start-up — establishing right-sized processes from day one, rather than adapting scaled-down enterprise processes
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Quality by Design and ICH E6(R3) principles embedded from the outset
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CRO and vendor selection, due diligence, contracting and governance — giving lean teams the experience to make informed partner decisions
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Risk-based oversight focused on what matters most to participant safety, data integrity, quality and timelines
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Practical use of AI and data analytics to improve real-time trial visibility — enterprise-grade insight without enterprise overhead
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Independent, experienced challenge to plans, assumptions, risks and vendor performance
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Senior clinical operations expertise available flexibly, scaled to the needs of your programme
Every study has different pressures, constraints and priorities. Biotech Biz provides flexible, focused clinical operations services — from addressing a specific challenge to providing experienced oversight throughout a critical phase of delivery.
Send us a message and we will arrange a confidential discussion about your requirements.
Spotlight
Study Start-Up
A start-up model built for the study you are running
The fastest route to activation is not always achieved by pushing every activity harder. It comes from understanding how work flows across the study and applying Lean, Agile and Theory of Constraints principles to identify what can be simplified, progressed in parallel or escalated before it affects the critical path.
We start by assessing:
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Which activities are essential
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Where decisions are being delayed
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Which constraints are genuinely limiting progress
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What is proportionate to the study's size, complexity and recruitment requirements
Start-up rarely falls behind because of one isolated delay. It slows when dependencies between regulatory, contracting, site, vendor, systems and Sponsor activities are not understood or actively managed.
Biotech Biz helps Sponsors distinguish genuine constraints from avoidable friction, so effort is focused where it can accelerate activation — rather than adding process where it cannot.
Together, we align on:
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Which assumptions need to be tested
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Which activities require close coordination
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What can be simplified or progressed in parallel
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Which metrics will show whether start-up is progressing as expected
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When intervention or escalation is needed
This creates a start-up model that reflects the study's operating context — protocol demands, country and site requirements, participant burden, recruitment expectations, and available Sponsor, CRO and vendor capacity.
The aim is not to apply the same start-up model to every study. It is to create the fastest credible route to activation for the circumstances in which each study must operate.
Plan · Align · Connect
Illustrative examples of the planning tools we tailor for each study:
Oversight Dashboards
Spotlight
Make visibility work for your study
Effective sponsor oversight starts by defining what leadership needs to know, how information should be interpreted and what action should follow when performance moves outside the expected range. Sponsors need visibility that reflects their study objectives and risks — not simply the information routinely reported by a CRO or vendor.
Biotech Biz helps Sponsors establish dashboard requirements that reflect their study objectives, critical milestones, operational risks and governance needs.
We can support you to:
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Define the oversight questions your dashboards need to answer
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Identify the metrics, trends and thresholds that matter
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Set clear requirements for CRO and vendor reporting
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Assess whether existing dashboards provide sufficient visibility
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Develop dashboards through your CRO, existing systems or AI-enabled tools
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Connect performance, risk, impact, ownership and next action into a single view
Our role is to bring the clinical operations oversight and independent challenge needed to ensure that dashboards are working for you—not simply tracking.
The right dashboard does more than show what happened. It helps leadership see what is changing, what may happen next, and where action is needed.
Visualise · Identify · Act
Illustrative examples of study dashboards we can support you with establishing:
