MDVS Clinical Pty Ltd
Pharmaceuticals - Melbourne, Victoria, Australia
MDVS Clinical Pty Ltd Employees
MDVS Clinical Pty Ltd Details
An independent consulting service for the biotechnology/pharmaceutical sector offering technical expertise in clinical development & operations minus the overheads.Michelle is an exemplary leader in the delivery and execution of clinical trials with over 25 years of industry experience and a proven ability to oversight, manage and execute clinical trials across Australia and New Zealand, China and Bangladesh. She has worked across various clinical operations' business models for clinical execution and delivery.Michelle has collaborated with key medical researchers in diverse therapeutic areas to bring clinical trials to patients. She is a unique personality with strengths in engaging leadership, teams, sites and patients alike to connect, educate and deliver clinical trials to the highest standards.Services include:- Protocol and ICF development- KOL/site identification & feasibility assessments- Regulatory advice, applications and submissions (Ethics & TGA/Medsafe)- Study start-up including regulatory approvals and budget development & negotiation- Clinical monitoring and co-monitoring from site initiation to close-out- Project and trial management- Vendor and CRO oversight- Patient engagement & recruitment strategies- Site engagement and training- Quality improvement initiatives- Market feasibility of pipeline products- Cross-functional and cross-geographic alliance for early and late phase drug development, post-trial access and commercial planning- Risk assessment and issue mitigation across clinical programs- Change agent in supporting business needs- Financial management of functional budget- Relationship management of CROs, research institutions and clinical service providers/vendors ensuring timely and quality deliverables- Patient advocacy engagement to support awareness and recruitment strategy- Line management & development- Resource management- Coaching and mentoring- Team building and development
