We manage the successful delivery of the individual components of our Clients’ Clinical Development Plan.
How do we do this?
Project team leadership and communication ensures a productive and functional team. Our Project Managers are successful with project delivery and have strong interpersonal skills to lead and motivate the project team. Whether our Project Managers are required for the entire Clinical Development Plan or for an individual study, they have the skills and proven track record in delivering a project of comparable size and complexity to an agreed budget and timeline. This is key. And this is our expertise.
We work with our Clients to establish the best operational model for their project, whether this is a stand-alone Quorum Solutions project team or an integrated project team of Client and Quorum Solutions team members.
We assess and plan for each study and determine the resources, tools and supports required to ensure a successful outcome so there are no surprises. Expectations are clearly outlined up front. We establish the right multi-disciplinary project team and this team will have the expertise to deliver the Project Plan for each study or component of the Clinical Development Plan as required.
What do we manage?
- Continuous monitoring and review of the project
- Regular communication with the Client on project status
- Implementation of risk mitigation strategies to avoid or solve problems if they arise
Study Management of all aspects of a clinical study
- Site feasibility and selection (nonclinical study units, Phase 1 clinical pharmacology units or clinical sites for multi-centre studies)
- Site management
- Site monitoring for clinical studies, including risk-based monitoring
- Registration and updating of clinical study on required trial websites to meet publication requirements, for example, www.clinicaltrials.gov
- Service Provider selection and management
- Investigator meeting for a clinical study
- Clinical Study kick off meeting and Site training
- Regulatory and Ethics Committee submissions and approval(s)
- Clinical Study master file set up and maintenance
- Clinical Study participant recruitment and retention
- Study supply management
- Safety Committee oversight and coordination including charter development
- Medical monitoring for a clinical study
- Safety management and reporting for a clinical study
- CRF development and completion guidelines (electronic/paper), database build, data management
- Statistical programming, analysis, statistical output review and reporting
- Quality assurance
- Medical writing
- Protocol development, finalisation and amendments
- Investigator Brochure
- Clinical Study Report writing and finalisation
Management of Australian and International Service Providers (such as contract research organizations (CROs), contract manufacturing organizations (CMOs), central laboratories (clinical safety, bioanalytical), specialised laboratories (pharmacodynamics biomarkers, ECG)
- Identification and selection of third-party Service Providers via a rigorous process to ensure that the precise service required for the project can be delivered to the required standard, timeframe and budget. Depending on the service, inspections and/or quality audits of the provider may be recommended.
- Continuous management and oversight of Service Providers via their inclusion into the team as project team members.
Management of Regulatory submissions