Our services
The primary differentiator for H&A Clinical is our founder's extensive experience and deep understanding across multiple silos within the medtech industry.
This enables us to provide tailored solutions to our clients, ensuring that their unique requirements are met with the highest standards of quality and expertise.
Clinical Research Organisation (CRO) Services in Australia
Essential Documentation writeup: Clinical Investigation Protocol (CIP), Investigator Brochure (IB) per ISO 14155 or ICH GCP
CRF and worksheet design
Study close out
Clinical field specialist support: clinical education and training, in-field support
Regulatory & administrative support: HREC, RGO, CTN submissions
Study monitoring and project management: SDV, SDR, safety reporting, study compliance
Study oversight management: convening Investigator meetings, Data Safety/Monitoring Boards, KOL engagement
Field Clinical Engineer (FCE) Services
Clinical education and training
in-field support
Technical and engineering support across various medical specialisations
Multidisciplinary site liason and relationship management
PHD Qualified Engineer
on-site support and training
Technical and pragmatic input
Reporting and report writing
R&D - Technical & Clinical services
Product design & development
Prototyping and design for manufacture (DFM)
Verification and validation (V&V)
Production planning
Risk management file (hazard analyses, design/user/process FMEAs)
Clinical Evaluation Plan/Report (CEP/CER) writing
Technical File development
Manuscript writing/preparation for scientific journals
Quality Management & Regulatory
Regulatory & market access strategy (CE and TGA)
QMS design and implementation (ISO 13485, 21 CFR 820)
Regulatory submissions – conformity assessment (CE and TGA)
Support for Notified Body/Competent Authority audits
Post-market surveillance and regulatory reporting
Business consulting
Product commercialisation strategy
Product launch strategy
Device funding and commercialisation
Technical training: GMP (ISO 13485), CGP (ICH-GCP and ISO 14155)
Grant writing and application preparation
Clinical and Engineering teams setup and mobilisation - Fractional COO or GM consulting
Australian Clinical Trial Sponsorship
Australian Company setup and ASIC Registration
Australian trial site initiation and liaison
Legal contracts preparation
Financial and Regulatory mandatory reporting
Site budget and trial initiation preparation
Administrative, Legal, Clinical and Engineering teams setup and mobilisation