Experience and Specialisations

Sector Specialisations

Service Specialisations

Clinical Operations Oversight

Clinical operations oversight is essential for overseas biotechs running studies in Australia and APAC. As an in‑region consultancy, we help sponsors stay closely connected to their trials through local insight, timely communication, and an understanding of regional nuances. Our proximity to sites and CRO partners enhances awareness of monitoring activities and supports effective issue escalation. With ICH GCP E6(R3) increasing expectations for continuous, risk‑proportionate sponsor oversight—even when activities are outsourced—we act as a trusted extension of the sponsor team, helping them fulfil these obligations with greater confidence and continuity across the region.

Clinical Project Management

Clinical project management keeps a study moving smoothly by coordinating timelines, vendors, site activities, and cross‑functional planning. For overseas biotechs running trials in Australia and APAC, our in‑region presence improves communication, reduces delays caused by time‑zone gaps, and helps sponsors navigate local operational nuances that affect study delivery.

Clinical Monitoring and Oversight Monitoring

Clinical Monitoring: Monitoring ensures sites conduct trials safely, compliantly, and according to the protocol. Being based in‑region, we help overseas sponsors stay closely connected to site activities by bridging time zones, strengthening communication, and providing local insight into how studies actually operate across Australia and APAC—supporting smoother monitoring interactions and faster issue resolution.

Clinical Monitoring Oversight: ICH GCP E6(R3) increases expectations for sponsors to maintain continuous, risk‑proportionate oversight of outsourced activities, including monitoring workflows and issue management, and to have timely visibility of operational data to detect emerging risks earlier.
As an in‑region consultancy, we help sponsors meet these obligations by offering local context, clearer communication with CROs and sites, and real‑time awareness of what’s happening on the ground—acting as a trusted extension of the sponsor team while they retain full oversight responsibility

CRO & Site Training

We help overseas sponsors deliver clear, practical training to CRO and site teams across Australia and APAC. Being locally based, we provide context‑relevant guidance, strengthen communication, and ensure teams understand how study expectations translate into day‑to‑day operations—improving consistency, reducing errors, and supporting smoother trial delivery.

Therapeutic Area Experience

Oncology

Haematological malignancies (lymphoma, multiple myeloma, acute myeloid leukaemia, chronic lymphatic leukaemia), solid tumours (prostate, renal, breast, colorectal, glioblastoma multiforma, ovarian, NSCLC, head and neck, urothelial, hepatocellular, gastroesophageal, pancreatic) and melanoma

Dermatology

Skin allergy, psoriasis

CNS

Psychiatry, PTSD, Alzheimer’s, anxiety, depression, cannabinoid

Infectious diseases

Influenza, severe bacterial infection, nontuberculous mycobacteria

Vaccines: Influenza, RSV

Respiratory: Emphysema, cystic fibrosis, intra-nasal, COVID

Gastrointestinal

Irritable bowel syndrome (IBS)

Cardiovascular

Heart valve device, atrial fibrillation, hypertension