CRA /CRO SERVICES
We provide streamlined clinical trial services to suit the individual needs of the client. Some of the services we have supplied to Sponsors and CROs to date include site selection and feasibility, study set up and site initiation, budget and contracts, project management, monitoring, SOP development, auditing, training and quality assurance.
We enjoy working closely with our clients to provide solutions for the efficient conduct of their clinical trials and research wherever they are located.
Identifying the right clinical trial sites is essential to the success of the trial. We have access to a network of trial sites and investigators enabling us to find best fit for your study in terms of site capability and patient populations.
Once feasibility and site selection is completed, we can provide the following clinical operations activities to get the study up and running:
- Study start up
- Site management
- Monitoring activities
- Project management
We have experienced, appropriately trained monitors who are available for short-term contracts or less intense long-term contracts. As most of our monitors have worked as Study Co-ordinators, they are well equipped to work in a range of therapeutic areas, including oncology. All monitors are committed to ensuring compliance of the trial site with the study protocol, GCP and applicable regulatory requirements in Australia.
Do you have a site about to be audited? Do you need independent personnel to help the site prepare for the audit? Clinitrials has been engaged to work with sites pre-audit, at audit and post-audit. We work with sites to understand their processes and identify gaps, and then we then work with them to develop corrective and preventative actions. To date none of the sites we have assisted have had any critical findings.
mentoring new sites
Research sites are integral to the conduct of clinical trials and establishing new sites is difficult and costly for both parties. Clinitrials, as an independent party, can work with your new site and provide the guidance and skills required to enable the site to recruit effectively and complete study processes in compliance with GCP and the study protocol. This results in reduced monitoring time and development of sound processes for future trials.
Efficient and timely study start up is a vital component of a successful trial. Clinitrials can manage study all start up activities for you including:
- Site qualification visits
- HREC submissions
- Budget and contract negotiations
- Essential documents