The cost of developing a drug is staggering and the situation can be quite problematic and fraught with challenges if your clinical team is inexperienced in Clinical Project Management /Clinical Operations. Specifically, if they are having difficulties with subject recruitment, site initiation, Investigative staff collaborations, data collection and analysis, database lock, timeline management, vendor management and regulatory compliance. These can be overwhelming if you do not have a clinical team or if you do not have the expertise to address the challenges and can maneuver through the drug development maze.
I can be your solution. I can be your team. I can offer you my experience and "hands on" knowledge of the Clinical Drug Development process from study initiation through study closeout including database lock. I have a wide range of clinical experience which will be the answer to an organization's problems especially when experience is the key to getting to the market without costly mistakes.
I have extensive experience in solving complex problems in the both a medium and large Pharmaceutical and a small or emerging Biotech setting.
I deliver value through my solid understanding of the clinical development process, my passion for clinical operations, my focus on compliance and overall quality improvement, as well as my ability to think strategically.
What sets me apart from other consultants is my ability to be a critical thinker and, my ability to devise simple common sense solutions to complex problems. I provide high quality development, management and oversight of global clinical trials. This results in greater accuracy, quality, higher efficiencies, quicker turnaround and cost savings.
Reasons to Choose Me
- Experience with Phase 1, Phase 2, and Phase 3 Global Clinical Trials
- Primary theraputic area -- Oncology
- Deadline driven based on FPFV and LPLV and database lock
- Meet Senior Management Goals and Objectives