Our self-contained Phase 1 Unit offers you a range of high-quality Phase 1 and 2 studies whether your need is for over-night or out-patient facilities. Our qualified staff take good care of both your volunteers & patients and your studies and are highly committed to timely provision of quality services exhibiting competence and compliance to the standards of GCP, GLP, GMP and all relevant regulatory requirements.

Effective project management is essential to meet study timelines. Our clinical project managers lead dedicated study teams who meet, plan and document the progress of your study. They are your main contact to keep you updated throughout the trial.

Being Australia based, 24/7 teleconferences with our overseas customers is part of our routine service.

• First time in Human
  Our Unit is ideally suited to run first-time-in-human (FTIH) studies due to our location within the Prince of Wales Hospital, with immediate access to medical emergency services around the clock. We are experienced in running FTIH single and repeat dose escalation studies with an impeccable safety record. Our trial physicians provide you with on-going high quality clinical safety reports designed specifically for your needs for rapid progression of the study according to agreed timelines.
• Bioavailability
• Bioequivalence
• Drug and Food Interaction
• Pharmacokinetic/Pharmacodynamic (PK/PD)
• Complex Experimental Medicines and PD Endpoints
  New ways of studying the action of medicines in humans are constantly required in order to keep pace with the rapid developments in science and technology. The GSK MRU has been involved in the development of ways in which efficacy of new medicines can be determined.
• Patient Groups
  Small groups of patients with specific health disorders are sometimes recruited for detailed studies in the mechanism of action of new medicines (Phase 2a). To date these disorders have included: migraine, dyslipidaemia, hypertension, obesity, asthma, chronic obstructive pulmonary disease, allergic rhinitis, osteopaenia, rheumatoid arthritis, osteoarthritis and neropathic pain, overactive bladder and liver failure. 
• Ethnopharmacology
  Sydney is a multicultural city of over 4 million people allowing the Unit to recruit defined ethnic groups. Ethnopharmacology studies have been conducted to assist in drug registration in Korea and Japan. We provide volunteers with standardised protocol specific menus and in-house accommodation adaptable to their cultural and language needs. Clinical staff and interpreters of the relevant ethnic population are present from consenting throughout to the final visit to ensure the volunteers’ comfort, wellbeing, and comprehension requirements are met as well as ensuring that there is correct documentation of all events.
  

We offer protocol development, production of study reports, Informed Consent Forms and study manuals. The Operations Manager leads a team of qualified staff members and supervises the development of documents in close communication with our customers. The General Manager, Project Managers and other study team members may also contribute to the review process of any specific documents as required.

We have an innovative and dedicated recruitment department including an in-house call centre that provides enrolment of sufficient volunteers and patients into your studies to reach the protocol specific target. Our recruitment manager supervises a team of trained and friendly recruitment officers who utilize innovative marketing strategies as well as traditional recruitment methods, thereby attracting healthy volunteers and patients for both, study enrolment and for registration into our custom designed volunteer database. The database allows for quick report generation to sort volunteers and patients demographically and by specific volunteer and patient profiles.

Our well established relationship with the Prince of Wales Hospital allows us to collaborate with highly recognized specialists and consultants for studies in specific patient populations. This collaboration may involve initial discussion on protocol design and feasibility, the method and timing of patient recruitment as well as consultancy during the study.

All our studies are usually done under the Clinical Notification Scheme (CTN) and therefore only notification of and acknowledgment from our Australian regulatory authority, the Therapeutic Goods Administration (TGA) is required for protocols subsequent to final Ethics Committee approval.

We currently use two Ethics Committees for review of studies placed at the Unit: our local Human Research Ethics Committee of the South Eastern Sydney and Illawarra Area Health Service, Northern Network &/or Bellberry Limited. The South Eastern Sydney and Illawarra Area Health Service, Northern Network meets monthly and is based within the hospital campus, and Bellberry Limited is a private not-for-profit organisation which was developed following the recognition for the need of a Human Research Ethics Committee to service the private sector - Bellberry Limited manages the Bellberry Human Research Ethics Committees.

Every study is conducted in compliance with international regulations (e.g. ICH GCP & GMP), applicable Australian regulations (e.g. TGA and the NHMRC) as well as with relevant sponsor requirements and policies.

We prepare the complete Ethics Committee application package for submission for you. We will discuss with you the relevant documents and information that we would require for submission.

Ethics Committee submission and meeting dates can be obtained on request.

Professional and careful processing and storage of your study samples is done in our dedicated laboratory, which includes a well organized sample preparation area alongside standardized equipment which complies with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

Special in-house laboratory services provided by our specialist staff include:

• Complex platelet aggregation studies including protocol development and method validation
• Analytical ultracentrifugation
  
  

Biochemistry, hematology, urinalysis, serology and other pathology tests will be contracted out to a local Pathology Laboratory with NATA/RCPA* accreditation in accordance with ISO/IEC 17025 (1999) which includes ISO 9002:1994

*National Association of Testing Authorities, Australia in conjunction with Royal College of Pathologists of Australasia.

Sample shipment: We take care of the shipment logistics and coordination of your study specimens to ensure each sample arrives at its destination laboratory in the appropriate condition – frozen, on dry ice, chilled or at ambient temperature. We only use preferred couriers with a proven track record of outstanding services and a knowledge of handling biological specimens.

Quality is at the heart of everything we do – from planning through to clinical trial management, clinical vigilance and laboratory procedures – and it is vital to the delivery of reliable science for drug development.

Internal quality improvement and quality assurance programmes aim to improve quality and business performance as well as provide a tool for monitoring and evaluating compliance and the quality of data and procedures.

GSK MRU specific local policies (SOP’s and POL’s) are in place to describe or provide supplemental details where documents from global GSK headquarters or external sponsors provide insufficient description of local policies and procedures.

The Unit is also on the audit schedule of GSK World Wide Clinical Compliance for regular GCP, GMP and various system audits.