Our service expands beyond providing a CRA CV as we wish to provide a solution to the Client’s needs which encompasses:
- Relevant therapeutic experience
- Extensive expertise/know-how in monitoring/site management operations
- Cultural and personality fit
- Regional monitoring and travel budget to investigator sites
- Ongoing contractual management with the CRA/REG and support to the Client.
Klinikos CRA/REGs are experienced, ex-industry and work from a home office set up. Klinikos CRAs can perform all aspects of study start-up, regulatory, and clinical monitoring including:
- Assist with Regulatory Submissions
- Undertake Site Management
- Manage monitoring plans, timing and logistics
- Conduct investigator pre-study meetings
- Assist the co-ordination of investigator meetings
- Conduct study initiation site visits
- Conduct regular monitoring visits / telephone contacts
- Manage adverse event reporting
- Monitor Case Record Forms (CRF) and eCRF
- Perform Source Data Validation
- Perform Drug Accountability Checks
- Perform correct/query resolutions
- Undertake study closure visits
As a niche service clinical research provider to the pharmaceutical industry, Klinikos understands the challenges presented by Investigators, Freelance CRAs and the Sponsor. Our team has experience working with Pharma, CROs and SMOs and we have seen what are often conflicting requirements from all parties and how best to resolve them.
Alanna Stewart – Client Relationship Manager
Alanna joined Klinikos in 2019 working as part of the Business Development team and providing administrative support in managing RFPs and contracts. Now, as Client Relationship Manager, Alanna is the first point of contact for our Clients and manages the interactions between Klinikos CRAs and our Clients to provide a smooth collaboration and regular contact between all parties.