Angie Edwards
Founder & Director of Project Delivery, Bubble Clinical Research Services, NZ
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Starting her career in the UK, Angie’s 23 years in the clinical trial industry has seen her achieve PharmaTimes CTA of the Year in 2004 and complete CRA training at a global pharmaceutical company. Angie then emigrated to New Zealand in 2006 and performed CRA and start up activities for 7 years in CROs for commercial Phase I-III studies, including devices and diagnostics, across many different therapeutic areas, working under a CCRA qualification. Angie then progressed to project management from 2012, where her most significant contributions were in early Hepatitis C studies, a global maternal vaccine study for paediatric RSV and early phase / healthy volunteer trials, whilst obtaining a PMP certification.
Often, as the main point of contact for internationally sponsored clinical trials, Angie is adept at informing study operational teams on the NZ-specific processes and timelines maximising efficiency for both client and sites in delivering high quality data, whilst keeping our participant needs front of mind. This year, Angie has founded Bubble Clinical Research Services, a company that strives for excellence in the clinical trial services they deliver and driving new business into New Zealand enhancing our ever-growing, impressive reputation. |
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Decreasing Noncompliance Issues: Working Together from the Start
- What is a protocol deviation (PD)?
- How can PDs be avoided?
- Do the number of PDs reflect badly on the site / operational teams?
- Do CRAs get paid to find protocol deviations?
In order to obtain dependable, robust, good quality data, the protocol must be designed in a way that study assessments are performed consistently across time, staff, participants, sites and countries. One method to measure that consistency is to measure the number of times the actual assessment data have deviated from the plan.
Angie will cover:
- the fact that the definition of a PD can vary slightly between sponsors and CROs, and hence strategies to overcome.
- Whether PDs can be completely avoided or whether they are to be accepted, fait accompli, given there are many stakeholders which impact this target, including sponsor, CRO, site, vendors and participants.
- An unclear protocol, an uncooperative participant or a complacent vendor all have equal responsibilities in the number of PDs, as well as the site’s performance.
- CRA and Data Manager, friend or foe?
Join this session to hear a project manager’s perspective on how we can work wiser together to improve the quality of data provided to our clients.
