The right expertise. At the right stage.

Develop and refine the scientific rationale, objectives, endpoints, study procedures and operational detail of a clinical study protocol.

For

Academic investigators and sponsors translating a research concept into a clinical study.

When

During study planning, before ethics submission, or when a substantial amendment is needed.

Deliverables

Protocol drafts, an amendment log, a schedule of assessments and a review-ready document.

Our support

We work with your investigators and relevant specialists to bring scientific intent and operational feasibility together.

Organise available non-clinical and clinical evidence into a structured Investigator’s Brochure, with traceable references and clearly identified evidence gaps.

For

Sponsors and emerging therapy developers preparing investigational product documentation.

When

Before clinical study preparation and when new product or safety evidence warrants an update.

Deliverables

An evidence inventory, a structured draft, reference checks and a controlled revision history.

Our support

We coordinate scientific input and document review. The sponsor retains responsibility for the completeness and approval of product information.

Draft, edit and reconcile scientific and study documents for their intended audience and purpose.

For

Investigators, sponsor teams and institutions needing additional writing capacity.

When

Across study preparation, conduct, reporting and publication planning.

Deliverables

An agreed writing brief, referenced drafts, consolidated reviewer comments and a final document set.

Our support

We establish the evidence base, audience and review process before writing. Authorship and publication responsibilities are agreed separately.

Support the preparation and coordination of Human Research Ethics Committee and site governance documentation.

For

Investigator-initiated study teams and sponsors preparing Australian research submissions.

When

Before study commencement, when adding sites, and for relevant amendments or reporting.

Deliverables

Submission checklists, coordinated document packages, response drafts and a decision tracker.

Our support

We map the requirements with your team and coordinate document readiness. Review decisions and approval timing remain with the responsible bodies.

Compile and quality-review study documentation against the requirements identified for the project.

For

Sponsors and developers preparing a clinical research programme or updating an existing one.

When

During development planning, study preparation and significant product or protocol changes.

Deliverables

A documentation gap assessment, a document register and agreed submission-ready materials.

Our support

We clarify the documentary workstream and coordinate specialist input. Product classification and pathway decisions require study-specific assessment.

Coordinate feasibility information, site documentation, readiness activities and study startup dependencies.

For

Investigator teams and sponsors preparing a new study or additional site.

When

From early feasibility through to agreed site activation requirements.

Deliverables

A startup plan, readiness checklist, action tracker and organised essential documentation.

Our support

We help teams understand outstanding actions and owners. Site activation is subject to approvals, agreements and sponsor authorisation.

Perform agreed monitoring activities against the protocol, monitoring plan and delegated scope, with follow-up of findings.

For

Sponsors and research teams needing contracted monitoring capacity.

When

At initiation, during study conduct and at close-out, as specified in the monitoring plan.

Deliverables

Monitoring visit preparation, reports, finding logs and documented follow-up.

Our support

We agree the monitoring approach, access arrangements and escalation pathways before work begins. Sponsor oversight and investigator responsibilities remain defined.

Support agreed administrative workflows for SAE collection, tracking, reconciliation and reporting coordination.

For

Sponsors and study teams needing defined safety operations support.

When

Before first participant enrolment and throughout study conduct and safety follow-up.

Deliverables

Safety workflow documents, tracking tools, reporting coordination records and reconciliation logs.

Our support

We agree reporting roles and escalation routes in advance. Medical assessment, causality decisions and sponsor reporting accountability require explicitly designated qualified personnel.

Organise, maintain and review essential study documentation within an agreed Trial Master File structure.

For

Sponsors and operations teams maintaining paper or electronic study records.

When

At study setup, during conduct, ahead of review and at close-out.

Deliverables

A filing plan, document index, completeness reviews, issue logs and an agreed handover package.

Our support

We establish document ownership, access and filing conventions with your team. Hosting, retention and system responsibilities are agreed in the project scope.

Develop practical quality processes and standard operating procedures that reflect the organisation’s activities and responsibilities.

For

Research groups, sites and sponsors building or improving their quality framework.

When

Before a programme begins, during process review or when gaps are identified.

Deliverables

A process gap review, prioritised SOPs, controlled templates and a document management plan.

Our support

We co-design procedures with the people using them and define review and training needs. This service does not constitute certification or independent accreditation.

Prepare and deliver training on agreed study processes, documentation and role-specific activities.

For

Investigators, research coordinators and site teams preparing for a study or process change.

When

Before study activities begin, at team onboarding and following relevant amendments.

Deliverables

A training needs outline, tailored materials, attendance records and agreed knowledge checks.

Our support

We adapt sessions to the protocol and site workflow. Training does not replace professional qualifications, institutional requirements or required GCP training.