Support shaped around your study.

Study Start-Up & Activation

Practical support with feasibility, start-up planning, essential documentation and submission coordination, through to operational readiness and site activation.

• UK: Experienced support with the preparation and coordination of REC, HRA and MHRA submissions, including Combined Review through IRAS where applicable, alongside study start-up and NHS site activation.
• US: Support with Institutional Review Board (IRB) submission preparation, study documentation and approval tracking, working with investigators and institutional teams to meet the reviewing IRB’s requirements.

A start-up plan with submission requirements, responsibilities, dependencies and the steps needed for activation.

Trial Management & Ongoing Study Support

Trial management from start-up through close-out, including timelines, submissions and amendments, recruitment oversight, vendor coordination and trial master file (TMF) or investigator site file (ISF) maintenance. Support can also cover monitoring preparation, follow-up actions and archiving coordination, for a defined assignment or ongoing responsibilities.

Agreed trial management responsibilities, with support delivered for a defined assignment or on an ongoing basis.

Study Budgets & Costing

Develop, review and maintain study budgets, from trial start-up and submission to academic grant applications and ongoing delivery. Review the activities, staffing and resources needed, identify omissions and check the assumptions behind the costs.

• UK: Academic grant costings, Schedule of Events Cost Attribution Tool (SoECAT) support for non-commercial research, and NIHR interactive Costing Tool (iCT) review for commercial studies.
• US: Clinical trial and site budget development and review, including start-up, per-participant, procedure and close-out costs, alongside academic grant budgets and budget justifications.

A developed or reviewed budget with written comments, documented assumptions and agreed updates as the study progresses.

Protocol & Schedule of Events Operational Review

Review of protocols and schedules of events to identify practical challenges, resource implications, workflow issues and barriers to successful delivery.

Written operational comments on the protocol and schedule of events, highlighting practical issues, resource needs and questions to resolve.

Investigator-Initiated & Translational Research

Operational support for investigator-initiated and translational research involving sites and laboratories in the UK, US and internationally. This includes funding requirements, ethics submission preparation and coordination, multicentre working and tissue or sample logistics. Support also covers research contracts and material or data transfer agreements (MTAs/DTAs), coordinated with institutional and legal teams.

A coordinated approach that connects the research aims with practical requirements and responsibilities.

Operational Roadmaps

Develop a working plan that brings together study requirements, responsibilities, timelines, dependencies and outstanding decisions. This can guide a new study, a transition or the next phase of an existing project.

A working study plan with milestones, responsibilities, dependencies and prioritised next steps.

Audit & Inspection Readiness

Practical preparation for sponsor audits and regulatory inspections, including essential document and process review, gap identification, evidence organisation and team preparation. Support can also include coordinating responses to findings and agreed corrective and preventive actions (CAPAs) with the responsible study team.

A prioritised readiness review and action plan, with preparation and follow-up support scoped to the study.

Study Recovery & Operational Troubleshooting

Focused reviews of study operations to identify gaps, improve workflows and address delivery risks. Where a study is delayed or facing difficulties, support can include identifying the barriers and developing a practical recovery plan.

A focused assessment with prioritised recommendations and agreed actions.