Accelerating your clinical development program from Project Management through to clinical trial monitoring, management and patient recruitment.
Optus Research & Analytics’s streamlined and integrated clinical trial services are delivered by a dedicated team of professionals with deep industry and therapeutic area expertise across all phases of clinical development.
This, coupled with our deep understanding of operations in the American countries and strong relationships with trial sites - results in an efficient and effective trial start-up and recruitment of patients to achieve your goals.
Optus Research & Analytics is a fully Quality Endorsed Company compliant to the ISO9001:2000 standard, which means a structured, professional approach to all phases of your clinical research trial, from administrative requirements, contract and operational issues through to reporting and communication needs.
Optus Research & Analytics’s registration clinical trials services are designed specifically for sponsors without local presence in the countries in which we operate. In particular the depth of our regulatory expertise across the region adds clarity and transparency to the trial startup process.
Our customized service means all facets of a trial are covered by the one contract, including third party vendor management and local site agreements, making working with us a simple and streamlined process.
Your Project Manager will connect you to a full range of services including :
- Feasibility assessment and site selection
- Protocol development & CRF design
- Patient recruitment strategies
- Ethics Committee and Regulatory submissions
- Project management and monitoring for Phase I-IV trials
- Full biometrics services, including randomization and IWRS services
- Local sponsorship
- Third party vendor management
- Medical, technical and CSR writing
We are also able to propose and manage fully-vetted local vendors in areas in which we do not directly provide services ourselves. These include:
- Drug depot and logistics providers
- Central laboratories
- Translation service providers where required
- Phase I units
- Event managers (Investigators’ Meetings)
- Insurance brokers (indemnities)