A member of Avoca’s integrated consulting and Avoca Quality Consortium workstreams, Kristen Bennett provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca.

Kristen has 15 years of clinical trial experience with expertise in clinical trial execution, process development, and strategic management. Her previous professional roles include project, data, and site management.

Kristen’s clinical research career began as a clinical research coordinator at a large academic oncology institution where she was responsible for the recruitment, intervention, data collection, laboratory, and data analysis for studies across multiple therapeutic areas. Kristen transitioned into a research supervisory role with the primary responsibility of developing and providing education, orientation, and continuing education programs relative to conducting research protocols. Kristen has also co-authored several scientific abstracts/poster presentations.

As project manager at various CROs, Kristen ensured operational excellence within the project management group across a portfolio of studies. She participated on the Steering Committee of each study to analyze trial progress and mitigate newly identified trial risks. She also developed and evaluated study performance metrics against agreed-upon budget deliverables and timelines. Additionally, Kristen managed and coordinated the efforts of cross-functional project teams to support milestone achievement while implementing continuous improvement activities for internal and external risk mitigation.

Kristen holds a bachelor’s degree in Biology from Kutztown University of Pennsylvania.

As a team member of Avoca’s integrated consulting solutions and the Avoca Quality Consortium workstreams, Trevor Cole partners with subject matter experts to provide consulting services to clinical research sites, pharmaceutical, biotech, and contract research organizations of all sizes.

Trevor has 15 years of experience in health care delivery and management with 10 years in clinical trial development, execution, and monitoring. As a site and participant advocate, Trevor brings a passion for connecting the industry to a common mission of improving global health and wellness through equitable, meaningful, and high quality clinical trials.

Trevor’s clinical research career began as a laboratory research assistant and clinical research coordinator at a large academic institution, he then became a CRA in pediatric oncology before developing, leading, and growing a quality monitoring, management, and regulatory affairs program. Trevor’s other relevant experience includes emergency medicine and management of a multi-specialty innovative health center. Trevor is a registered nurse with a masters degree in business focused on health care administration and project management. Trevor holds his project management professional certificate from PMI and maintains certification as a clinical research coordinator through ACRP.

Michael has played a pivotal role implementing technologies and establishing processes and policies to enable Avoca’s growth since 2006. He oversees Avoca’s technology infrastructure, ensures organizational efficiency and security, and contributes to contract and administration processes across business areas. He has an integral role in technical execution and planning for Avoca Summits.

Michael has over 35 years of experience as an IT professional in the Telecommunications, Biotech, and Consulting industries.

Karen Harvey has 25 years of experience in healthcare and in the clinical research industry. As the Senior Director of the Avoca Quality Consortium, Karen has a focus on building strong client relationships, content creation, and expanding client knowledge of Avoca solutions.

Prior to joining Avoca, Karen’s previous professional roles included work as a Registered Nurse and then diverse roles within the clinical research industry at the site level and at CROs in Quality Assurance and Quality Management Oversight with focus on Sponsor/CRO oversight and strategic relationships.

Caryn Laermer is Head of Member Engagement for Avoca. She oversees strategies, initiatives, and communications; manages member engagement and recruitment; and plays an integral role in organizing Avoca Summits and AQC Member meetings.

Prior to joining Avoca in 2006, Caryn served as Vice President, Derivatives Group at Donaldson, Lufkin & Jenrette (now Credit Suisse), where she specialized in the sales and trading of stock options, foreign currency derivatives, and futures.

Ms. Laermer graduated from Tufts University with a BA in Economics. She is a member of Omicron Delta Epsilon, Economics Honor Society and holds an MBA in Finance from New York University.

Ann Linder is a Sales Manager on Avoca’s Client Development team. Ann provides leadership and support in maintaining healthy client relationships with AQC Members and consulting clients.

Ann’s previous experience includes providing life science consulting services and managing inside sales teams. She received her BA in Communication Arts from Washburn University.

Beth Listhaus is responsible for maintaining healthy client relationships and cultivating new business opportunities at Avoca. She also conducts client research. Prior to joining Avoca, Beth served as Associate Professor of Psychology at Dominican College where she chaired the Psychology Department.

Beth holds a PhD from Fordham University and a Bachelor’s degree from State University of NY at StonyBrook.

Jenn Loaiza joined Avoca in 2005 and is responsible for coordinating communications and engagement with Avoca’s clients and Avoca Quality Consortium Members. She also assists with client deliverables related to the company’s Research and Consulting services.

Jenn earned an MBA and BSBA with a dual major in Marketing and Management from Kutztown University of Pennsylvania, and holds an Associate’s degree in Visual Communications from Lehigh Valley College.

Lisa McKay is Head of Member Services for Avoca. She oversees the Survey Research project management team and works with AQC Members in a Client Engagement role.

Before joining Avoca, Lisa held executive level roles in Marketing and Business Planning both as an employee of entrepreneurial companies and as an independent consultant and mentor to early stage technology companies.

Lisa earned a BS in Biology from Bowling Green State University and holds an MBA from the University of Connecticut.

Patricia Leuchten is Founder of Avoca. She has more than 30 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing, strategic alliances and driving change in clinical trial execution through collaboration.

In 1999, she founded The Avoca Group, a consulting and research firm focused on the elevation of quality in clinical trial execution. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical research and clinical outsourcing and to measure the health of relationships between sponsors and CROs. In 2011, Patricia launched the Avoca Quality Consortium a member-based, pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers. Since its inception, the rapidly growing Avoca Quality Consortium is transforming clinical development by driving efficiency, improving quality, and mitigating risk in clinical trial execution.

Patricia is a frequent speaker and writer on topics surrounding clinical outsourcing, strategic alliances, quality management and relationship management in the pharmaceutical industry.

After receiving her Bachelor’s degree in Biology from Harvard University and her MS and PhD from Princeton, Dr. Denise Calaprice entered the world of clinical research as an NIH fellow at Columbia University’s College of Physicians and Surgeons in 1994. Over the subsequent decades, she acquired extensive experience in directing clinical research programs and in creating innovative development and operational strategies in a variety of settings, including academia, government, a CRO, a large global pharmaceutical company, and a small biotechnology company.

In her 14 years with Avoca, Denise has provided support to pharmaceutical companies, clinical service providers, university investigators, industry consortia, and government agencies engaged in clinical research, with a focus on partnering strategies, relationship management, metric development, protocol quality, patient engagement, risk management, “lean” development strategies, and business data analysis. Among her many accomplishments, Denise has developed a novel quality metrics taxonomy that has been adopted by top pharma organizations, and led development of the Avoca Patient Engagement Playbook.

Keith is a Senior Consultant with Avoca. He facilitates and provides thought leadership for AQC Metrics initiatives. As a qualified Master Black Belt of many years Keith has a solid background in the practical use of process improvement, business process re-engineering and metrics in clinical trials. He specializes in critical thinking and root cause analysis in clinical trials and is a frequent speaker at industry conferences.

Brigid Flanagan is a research professional with 20+ years in clinical operations. In her role as Senior Consultant for Avoca, Brigid provides input on operational plans, vendor qualification, and oversight for pharmaceutical clients conducting trials in the US and EU. She is passionate about research and the benefits it offers to participants.

Brigid has been an active member of ACRP since 1998 and most recently was Vice Chair of their Professional Ethics Committee.

She has an undergraduate degree in Sociology, trained as an RN in the UK, and completed a Masters in Bioethics at Union Graduate College/Mount Sinai School of Medicine in New York, NY.

Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO, and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting, and supplier alliance management.

As Senior Consultant with Avoca, Janis developed many of the quality oversight tools within the Avoca Quality Consortium Knowledge Center. She is the mastermind behind the Oversight Capability and Maturity Model (OCMM) and Provider Qualification work streams.

Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.

Helen Harlow has more than 30 years of experience in pharmaceutical drug development. Her knowledge spans human and veterinary Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), pharmacovigilance, medical devices and animal welfare requirements. She has conducted audits in Europe, USA, India and Japan. Helen’s career has taken her from conducting clinical studies for Pfizer Animal Health to Clinical Monitoring, Quality Management (where she designed the QMS), Quality Assurance (where she co-designed the QA program) to Departmental Management roles, and onto Pfizer’s Corporate Audit group. Helen then moved to the CRO Quintiles/IQVIA where she worked in Process QA, supporting Clinical Site Monitoring, Project Management and Records Management. Helen has been working as a Senior Consultant with Avoca since 2020, where she leads the Risk-based Quality Management Leadership Advisory Board and contributes to consultancy projects.

Helen has a BSc in Agricultural Zoology and a Diploma in Research Quality Assurance.

Dr. Irene Michas acts as a subject matter expert for the Avoca Quality Consortium and as a consultant on pharmaceutical quality. With a background in the pharmaceutical, biotech, and CRO industries, she brings extensive experience to diverse pharmaceutical development activities, including regulated business process development, business process and systems training, audits and regulatory inspections, product licensing agreements, clinical research and development, data management, personnel and contractor recruitment and onboarding, and the management and implementation of global projects and initiatives. Until March 2017, Irene was a senior leader within Pfizer’s pharmacovigilance organization, where she held the role of Regional Safety Lead.

Irene holds a PhD in Psychology and an MSc in Research Methods in Psychology from the University of Reading in the United Kingdom, as well as a Bachelor’s degree from the University of Pennsylvania.

Steve Whittaker is a Senior Consultant with Avoca and former Executive Director of the Avoca Quality Consortium. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies, and execution plans. His experience through years of drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.