| OUTSOURCING |
We Understand the Challenges faced by Companies in Identifying,
Selecting and Managing the Right External Service Providers
for Your Development Programme
Selecting and Managing the Right External Service Providers
for Your Development Programme
We have extensive experience in the tendering and selection process, and ongoing management of external providers (such as contract research organisations) to ensure that you are receiving the services that you require, that the services are fully compliant with the relevant local and international regulatory standards, and are being conducted in accordance with the contractual arrangements, including the agreed timelines and budget.
We routinely interact with third-party service providers based both within Australia, and globally.
Services include:
- Identification of third-party service providers potentially suited to the needs of the project
- Co-ordination of the tendering process, including preparation of the "Request for Proposal" (RFP) and detailed review of the quotations
- Provision of assistance to client in selecting the appropriate provider(s)
- Assistance with contract negotiations
- Selection of Phase I units (local & international) - including facility inspections
Management and/or oversight of third-party service providers such as:
- Contract research organisations
- Phase I clinical trial unit (e.g. for first in man, bioequivalence/bioavailability studies)
- Data management organisations
- Central laboratories (e.g. pathology, bioanalytical)
- Specialised testing laboratories (e.g. pharmacodynamic markers)
- Medical writers
- Clinical Quality Assurance (QA) Auditors