Clinical study start up is the phase where a clinical trial moves from intent to execution. Decisions made at this stage determine how quickly sites are activated, how reliably patients can be enrolled, and how much operational risk is carried into delivery. Sponsors and CROs that treat start up as a controllable, measurable phase are better positioned to deliver predictable timelines and avoid late-stage resets.
What is a Clinical Study Start Up?
Clinical study start up refers to the set of activities required to prepare a clinical trial for first patient enrolment. It spans early planning, feasibility assessment, budgeting and contracting, ethics and regulatory review, site readiness, and activation.
It is distinct from site start up. Study start up operates at the programme or protocol level, establishing the conditions under which sites can be initiated. Site start up focuses on executing those conditions at individual sites. In practical terms, study start up ends when sites are fully authorised and operationally ready to enrol patients.
Study Feasibility in a Clinical Study Start Up
Feasibility is a structured decision point, not a formality. During study start up, feasibility assessments test whether the protocol can realistically be delivered at proposed sites within required timelines and resources.
This includes evaluating patient availability, competing studies, site experience, staffing, and operational burden. Treating feasibility as an early gate allows sponsors to refine site selection, adjust assumptions, or pause studies before avoidable costs are incurred.
Budgeting and Contract Negotiation in a Clinical Study Start Up
Budget development and contract negotiation are among the most common drivers of start up delay. These activities establish the financial and legal framework under which sites operate and must be completed before activation.
Confidentiality agreements, site budgets, and clinical trial agreements can each become bottlenecks if ownership and escalation paths are unclear.
Efficient start up depends on early alignment, realistic costing, and disciplined contract workflows rather than late-stage acceleration attempts.
Ethics and Regulatory Review During Clinical Study Start Up
Ethics committee and regulatory reviews are core components of clinical study start up. These reviews confirm that the study is ethically justified, scientifically sound, and compliant with applicable regulations.
Depending on geography and study design, submissions may occur at sponsor level, site level, or both. Managing ethics and regulatory review as a parallel workstream, rather than a downstream dependency, is essential for maintaining start up momentum.
Roles and Responsibilities in a Clinical Study Start Up
Clinical study start up involves multiple stakeholders, including sponsors, CROs, sites, ethics committees, and vendors. Clear definition of roles and responsibilities is critical to avoid duplication, gaps, and stalled decision-making.
Project managers play a central coordinating role, maintaining timelines, tracking dependencies, and escalating risks. Sites contribute feasibility insight, documentation, and readiness activities, while sponsors and CROs retain accountability for overall delivery.
Tools and Process Standardisation for Clinical Study Start Up
Standardised tools such as checklists, timelines, and process maps are widely used to manage study start up. Their value lies in making requirements explicit and dependencies visible.
Process standardisation helps teams identify handoffs, reviewers, and approval points, reducing the risk of missed steps or unnecessary waiting time. It also supports more consistent execution across studies and sites.
In practice, technology supports these standardised tools and processes by improving coordination, visibility, and document management, without replacing the need for clear ownership or decision-making.
Common Causes of Clinical Study Start Up Delays
Delays in clinical study start up are rarely caused by a single factor. Common contributors include prolonged contract negotiation, ethics review timelines, protocol complexity, staffing constraints, and inconsistent communication.
Waiting time between steps, sometimes described as “whitespace”, often exceeds the time spent on the tasks themselves. Variability between site types and approval pathways further compounds delay risk.
Understanding where and why delays occur is a prerequisite to improving start up performance.
Measuring Clinical Study Start Up
Measuring start up performance allows organisations to move from reactive problem-solving to proactive improvement. Cycle time, approval duration, and handoff delays provide insight into where timelines are lost.
Without measurement, delays are often attributed to external factors rather than internal process design. Performance data helps teams distinguish unavoidable review time from avoidable waiting time.
Conclusion
Clinical study start up sets the trajectory for trial delivery. While complex and multi-stakeholder by nature, it is not inherently unpredictable. Clear scope, disciplined processes, defined ownership, and performance measurement allow start up to be actively managed rather than endured.
Quanticate combines experienced biometrics and clinical operations teams with inspection-ready data solutions to support efficient, well-controlled clinical study start up. If you would like support with feasibility planning, start up strategy, data management, statistics, or programming for your next trial, please request a consultation and a member of our team will be in touch.
