Maximizing Your Success In Pharmaceutical Trials Through Strategic Consulting
Partnering with you to achieve your success
Services Provided
Offering tailored solutions designed to meet your specific needs and contribute to the overall success of your clinical trials.
Clinical Trial Execution and Management
- Comprehensive project management and clinical operations services from study start-up through close-out for Phase 1 - 3 clinical trials.
- Expertise in navigating the complexities of biomarker-driven therapies and cell therapy trials.
- Specialization in cohort-driven studies including dose escalation and expansion, single-ascending dose, and multiple ascending dose trials.
- Development of project specifications for clinical trial costing strategies including review of costs and providing recommendations for vendor selection based on submitted proposals and bid defense presentations.
Development of Clinical Operations Infrastructure
- Support in establishing and/or enhancing clinical operations departments.
- Gap assessments to identify resource and process needs, including the development of workforce planning strategy and job descriptions.
- Creation of role-based training and RACI matrices.
- Development of Standard Operating Procedures (SOPs) including forms, templates, and work instructions.
- Provision of training sessions on the conduct of clinical trials
- Implementation, including vetting, selection, and set-up of eTMF, RBQM, CTMS, and eISF platforms.
- Inspection preparedness.
Clinical Trial Operational Strategy
- Provision of costing strategy and strategic text for proposals highlighting enrollment, feasibility, site selection, alternate scenario considerations, and competitive landscape based on therapeutic area and mechanism of action of the investigational product.
- Assessment of innovative technology solutions related to decentralized clinical trial strategies, trial participant identification and recruitment through EHR/EMR mining and use of claims data, site feasibility, laboratory sample management platforms, and risk-based monitoring from a business point of view to identify risks, benefits, and impact to processes.
- Development of Diversity and Equity Plans including strategies to address DEI initiatives.
Comprehensive Advice
Support throughout the entire process, including identification of strengths, weaknesses, and potential for improvements.
Manage & Development
Providing valuable insights and strategic guidance in the clinical research landscape
Customized Services
Tailored consulting services to address the unique needs of each client
Innovative Solutions
Passion for providing solutions that enhance operational excellence and overall trial success
About Me
Hello there! I'm Megan Liles, a seasoned professional with a rich and diverse background in the clinical research industry. My journey began in 1997 as a Research Coordinator in Detroit, MI, where I worked to recruit and follow persons living with HIV/AIDS into clinical trials. This was during a time when treatment options were significantly limited - the resilience and hope exhibited by these patients left an indelible mark on my professional outlook.
My career path has been a dynamic evolution, taking me from the role of Clinical Research Associate to Clinical Team Lead and Project Manager. With each step, I delved deeper into the intricacies of clinical operations, eventually assuming roles such as Director of Project Management, Global Head of Clinical Operations and Project Delivery, and then Vice President roles in Operational Strategy and Clinical Operations.
It has been my expertise in operational strategy and clinical trial management that have been a cornerstone of my career. I have led initiatives across CROs and pharma companies focused on applying innovative strategies and leveraging technology to optimize patient recruitment and engagement in clinical trials. In recent years, my focus has honed in on oncology trials, specifically in biomarker-driven and cell therapies.
Drawing from direct interactions with patients and my roots in a small US Midwest town, I've witnessed firsthand the challenges faced by individuals who must travel extensive distances to access critical clinical trials. This personal experience has ignited my passion for making clinical trials more accessible to patients and making them true stakeholders.
With a career spanning diverse roles, I am excited about the prospects of continuing to shape the landscape of clinical trials, ensuring that putting patients first remains at the heart of our endeavors.