Our Services
Clinical expertise tailored to your needs
With ClinOps Specialists, you gain a trusted operational partner committed to driving study success with transparency, accountability and excellence.
We provide customised, end-to-end Clinical Operations support tailored to meet the evolving demands of your clinical development programs. Whether you need strategic project oversight, functional support to extend your internal capabilities, or a turnkey outsourced solution, we have the expertise and agility to deliver.
Our experienced team integrates seamlessly with your organisation, offering specialised support across every phase of the clinical study lifecycle, from study planning and site initiation to regulatory submissions, participant recruitment, vendor management, data collection, study close-out and reporting. We understand the complexities of today’s clinical research environment and provide the tools and operational leadership needed to optimise timelines, prioritise critical activities, control costs and ensure compliance.
Whether you’re launching a First In Human study or managing a global late-phase study, we adapt to your preferred operating model and technology platforms to provide efficient, audit-ready solutions aligned with your goals.
Partner with ClinOps Specialists for tailored solutions that move your studies forward.
Our Clinical Operations services Include:
- Study planning & start-up
- Site management & monitoring
- Participant recruitment & retention
- Data management oversight
- Vendor oversight
- Study close-out
- Clinical development strategy
At ClinOps Specialists, we implement robust quality systems to ensure that every clinical study we support is conducted in full alignment with:
- ICH Good Clinical Practice (GCP)
- National and Regional Regulatory Requirements
- Ethics Committee Requirements
- Industry Best Practices
We can assist Clients with the design and implementation of a fit-for-purpose Quality Management System (QMS) tailored to the complexity, and regulatory obligations of the Sponsor’s clinical development programs.
This includes working closely with Clients to develop, review, update and maintain Standard Operating Procedures (SOPs) that support consistent, compliant clinical study execution and inspection readiness.
Partner with ClinOps Specialists for proven approaches that ensure regulatory compliance.
Our Quality & Compliance Services Include:
- QMS Support
- SOP development, review, and optimisation
- Inspection readiness planning
- GCP and regulatory alignment
- Integration of industry best practices
- Issue Management & CAPA Oversight
- Quality Oversight Planning
- Ongoing Quality Monitoring
We are skilled in project planning and management and will provide the level of assistance and oversight needed, depending on the complexity of the project. Our Project Managers take a key role in the team, developing excellent communication pathways with all stakeholders, coordinating work and allowing the other team members to focus on their areas of expertise.
As well as offering traditional project management techniques, our team includes PRINCE2 Agile® Practitioner expertise so we can advise on the best project management strategy for every project.
Partner with ClinOps Specialists to experience excellence in project delivery.
Our Project Management Services Include:
- Project planning
- Risk and issue management
- PRINCE2, Agile®, and traditional methodologies
- Gantt charts
- Presentation schematics
- Kanban