Affinity Virtual TrialsTrials without Limitation
Clinical Trials without Boundaries
Affinity has a history of using techology and out-of-the-box thinking to improve efficiency and quality of clinical trials. Our company has been set-up in a way that we are not reliant on any one physical location. Affinity has the ability and infrastructure to conduct trials anywhere in Australia*.
Affinity advocates minimal site numbers utilising satellite locations to increase the range of recruitment and the efficiency of trial conduct while decreasing admin time and overall cost.
Investigator Site Files are stored electronically with access available to all study staff from anywhere with a secure internet connection. Source Documentation is recorded and stored in deidentifiable format via a credible eSource platform. Both systems are FDA CFR Part 11 and ICH-GCP compliant and meet Australian Privacy Law requirements.
On-site monitoring visits are no longer required as Clinical Research Associates have access to our study systems remotely. This enables Sponsors to reduce the number of on-site visits or move to risk-based monitoring. Site staff receive instantaneous feedback from the Sponsor which is particularly helpful in the early stages of a research project to ensure correct interpretation of the study protocol.
Because Affinity is not restricted to any particular geographical location, we are able to expand our participant recruitment area to include rural and regional areas*. Local study nurses conduct participant visits under the supervision of the Principal Investigator with assistance from a local Sub-Investigator or the participant’s General Practitioner.
Physicians who wish to refer participants have the option to join a trial as a Sub-Investigator. This has dual benefits:
- Participants have continuity of care whilst accessing new therapies
- Physicians receive training and practical experience as clinical research investigators under the mentorship of an experienced Principal Investigator
Affinity caters for a wide range of outpatient clinical trials including Phase 1, 2 and 3. We have experience in a wide range of therapeutic areas including oncology, haematology, neurology, cardiology, respiratory, gastroenterology, hepatology, psychiatry and infectious diseases.
Affinity conducts inpatient clinical research in similar therapeutic areas at a limited number of locations within the Perth Metropolitan Area. We can assist with inpatient trials at other hospitals in Australia that do not have their own clinical research staff.
FIND OUT MORE
If you wish to find out more information about virtual trials, please phone our Business Development Manager on 0474 769 593 or book a call.
*Location for participant enrolment and study conduct may be limited by the requirements of an individual research project.