Clinical trial management requires the ultimate attention to detail. Many parallel and conjoint activities are overseen by our project manager who has meticulously drafted a plan with timelines and objectives. The project manager will:
- Provide detailed plans for trial execution.
- Facilitate and co-ordinate all trial phase activities such as site initiation, enrolment, follow up and close out.
- Streamline and expedite critical landmark activities such as TGA reporting, Site Selection, IRB/EC submissions and Governance.
- Schedule meetings as per your requirement.
- Provide minutes to meetings.
- Archive essential documents.
- Establish and maintain open communication channels.
- Manage Clinical Research Associates (CRAs).
We pride ourselves on being the exemplary central contact point between all the key stakeholders, ethics committees, regulatory agencies, vendors, and hospitals. We plan, coordinate, execute, and supervise your clinical trial with a standard of excellence. Our focus is on clear communication, tracking budgets, managing clinical trial tasks and delivering progress reports.
We tailor our team according to your clinical trial requirements. In addition to Sponsorship, FCE support, Clinical Research Associate (CRA) Support, Site Selection, Project Management and Monitoring, we offer our services for:
- Study Design
- Patient Recruitment Plans
- Data Management
- Safety & Pharmacovigilance
- Medical Writing
- Quality Management & QA
- Regulatory and Reimbursement Strategy Support
We adhere to ICH GCP, ISO 14155, and all applicable regulations and guidelines.
With responsibility for the initiation, management and financing (or arranging the financing) of the trial, the sponsor carries the medico-legal responsibility associated with its conduct. In addition, the Australian trial sponsor is also the entity responsible for:
- Submitting a CTN or CTX to the TGA, if applicable
- Quality and integrity of the clinical trial data
- All delegated functions in accordance with the
TGA: Guideline for Good Clinical Practice
Our service offering extends to trial sponsorship with our trusted partner meeting responsibilities outlined by the relevant regulatory bodies such as Medsafe and the Therapeutic Goods Administration Legislation.
Our Commercialisation service will bring your new products or services to market with targeted finesse and expedience. Our well established network allows for successful distribution, marketing, sales, customer support, and other key functions critical to achieving the commercial success of your new product or service.
Our services include:
- Metrics and Analysis of recruitment marketing initiatives
- Formulation of Market Development Strategies
- Market Penetration
- Business Development Strategies
- Extension of site network
- Commercialisation implementation working with our regulatory partners
- Post market education and training
- Product distributorship
- Product Sales
Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Our monitors oversee the progress of a clinical trial and ensure that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.