Clinical Operations
At ClinOps Specialists, we offer a comprehensive range of services designed to support the entire lifecycle of a clinical study, from initial start-up through to final close-out.
Our services are flexible and scalable, allowing Sponsors to engage us for full project delivery or targeted functional support, depending on their needs.
Whether you’re launching a First In Human study or preparing for pivotal Phase III, we bring senior expertise, proven tools and proactive support to help you deliver efficiently and compliantly.
At ClinOps Specialists, we provide expert guidance during the critical early phases of clinical study delivery ensuring your study is operationally sound and primed for activation.
Our team supports Sponsors in developing realistic, inspection-ready plans that accelerate timelines and minimise risks during start-up. From protocol input and feasibility assessments to submission strategies and site activation, we help lay the foundation for successful study execution.
Plan smart. Start fast.
Stay compliant.
At ClinOps Specialists, we provide experienced, hands-on oversight of Clinical Research Associates whether sourced by the Sponsor, a third-party, or subcontracted through us.
We create and implement a tailored, study-specific Monitoring Plan that clearly defines objectives and expectations, ensuring compliance, data integrity and consistent execution across all sites.
To reinforce site performance and monitoring quality, we also offer co-monitoring visits, providing early issue identification and real-time support, ensuring alignment with Good Clinical Practice and Sponsor standards.
Effective oversight is key to a successful study
At ClinOps Specialists, we support both sites and Sponsors in developing effective strategies to meet enrolment targets and keep participants engaged throughout the clinical study.
We work closely with Clients to ensure that enrolment goals are realistic, site-level plans are achievable, and that the study is set up for successful recruitment from day one.
Our team also advises on participant outreach and advertising strategies, helping to improve awareness, reduce barriers to participation and support long-term retention, ensuring alignment with regulatory and ethical standards.
We help bring the right participants into your clinical study and keep them engaged every step of the way.
At ClinOps Specialists, we bring extensive experience in the setup, management and oversight of clinical study data, ensuring that your study data is reliable, entered within agreed timelines and aligned with study objectives
We act as a proactive interface between the Sponsor and the Data Management Organisation, facilitating clear communication and accountability across all data-related activities.
Our goal is to ensure that data management processes run smoothly, meet regulatory expectations and support decision-making throughout the study.
Data quality is an essential part of a successful study.
At ClinOps Specialists, we provide comprehensive oversight of clinical study vendors, from initial vendor selection through to close-out, ensuring performance, compliance and accountability at every stage.
We work closely with both Sponsors and vendors to establish clear expectations, manage deliverables, proactively address risks and resolve issues to promote smooth study progress.
With our experience managing Clinical Research Organisations, laboratories, central services and specialty vendors, we help ensure every partner contributes effectively to the study success.
Sponsor oversight is critical as the Sponsor is ultimately responsible for all activities performed on a study.
At ClinOps Specialists, we develop and manage comprehensive clinical study close-out plans to ensure a timely and fully compliant transition from active study conduct to final reporting.
We coordinate with all stakeholders, including Contract Research Organisations, sites and vendors to align on close-out timelines, responsibilities and deliverables, from Last Participant Last Visit through to database lock, results disclosure and regulatory reporting.
Our structured oversight ensures that all study activities are completed efficiently and in full compliance with ICH GCP, regulatory and Sponsor requirements.
We ensure your study ends with the same precision and control as when it started, fully compliant, on time and inspection-ready.
At ClinOps Specialists, we partner with Clients and Key Opinion Leaders to shape smart, efficient and forward-looking clinical development strategies.
Whether you’re planning your First In Human study or preparing for late-phase studies, we help you design a roadmap that aligns with therapeutic goals, regulatory expectations, patient expectations and market potential, guiding your product as far as you want it to go.