Services offered for pharmaceutical and biotech industries and bio-medical researchers
Companion Medicine aims, through our experience in clinical research project management-service delivery and our dedicated trained staff and veterinary partner practices, to provide a smooth pathway to investigate treatment opportunities for pets with naturally occurring illnesses and to discover new treatment options:
- We assist with selection of an evaluator for pre-clinical toxicology programs to support Phase I-III veterinary clinical trials and product registration. We do this to ensure the safety of the medicines we may be asked to investigate in our companion animal patients.
- We facilitate the writing of the lay information sheets, consents and animal ethics committee submissions to support Phase II-IV clinical trials. We have knowledge of the Australian Pesticides and Veterinary Medicines Authority regulatory permit system, local state animal welfare legislation and federal National Health and Medical Research Council code of practice for use of animals in scientific research. Our partner veterinarians uphold the Australian Veterinary Association code of conduct related to animal welfare when conducting our projects.
- We understand that recruiting companion animal patients to clinical trials (and retention while on study) requires not just knowledge of the legalities but a consciousness and sensitivity to the emotional bond between an owner and their pet – their desire to provide the best standard of care. We create a beneficial situation for the sponsor, veterinarian partnering and the patient-owner
Companion Medicine can organise and manage clinical research projects by:
- Developing an appropriate clinical program to support clinical trials in the areas of diagnostics, therapeutics (drugs, vaccines, gene therapy, stem cells and biologics) and medical devices and monitoring equipment.
- Our particular areas of interest that are represented in general practice include oncology, cardiology, feline kidney disease, dermatology, arthritis, diabetic and obese patients.
- Assisting with principal investigator selection for concept design, protocol input and/or the study itself
- Coordinating the design, finalisation and sign off of study protocols
- Co-ordinating the contract, insurance and conduct of the clinical study (including accounting aspects)
- Providing additional in-house ‘good clinical practice’ trained nursing staff at veterinary partner practices to ensure sufficient internal resource to carry out the trial and to improve the quality and the logistics of the study.
- Monitoring the in-life phase of studies
- Reviewing draft and final study reports
- Liaising with local and overseas regulatory authorities, resolve regulatory issues, provide representation at Local and Overseas regulatory meetings
- Acting as a complementary local monitor for the QA process of the company to the standards of VICH
- Assisting with clinical dossiers for submission to regulatory authorities
Director and principal consultant: Dr Amanda Craig, BVSc, M Vet Clin Studies, MACVS (canine medicine) has extensive experience setting up and conducting a contract research organisation in a large veterinary academic institute in the UK, undertaking varied studies for multiple companies and biomedical research partners, from the hospital caseload.
While in France she took part in a large field study into renal function in healthy purebred dogs which began her continued interest in pharmacogenetics. She has an appointment as senior lecturer in clinical trials, within the Discipline of Pharmacy, Faculty of Health, at the University of Canberra. Here she hopes to advance research in Comparative Clinical Science or ’One Medicine’ selected topics.
Companion Medicine also has access to an extensive network of professionals to provide services outside areas of expertise, particularly in the area of biologics, epidemiology and expert veterinary clinical key opinion stakeholders (locally and internationally).