Getting a drug to market used to be relatively simple and straightforward. That is not the case anymore. Clinical trials, from first-in-human to post-submission, face new challenges every day, including those related to clinical sample collection. Whether it is the treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there seems to be a massive rise in complexity.
Most Phase II and Phase III studies have multiple endpoints and procedures per patient generating millions of data points from a single study, and with the exponential rise in technology and capability, these numbers are only going to go up. Not only is this more burdensome for patients and sites to recruit patients, but it also increases the complexity of the logistics and sample handling for trials since data associated with sample collection comprises the majority of data for any submission.
Investigator sites are collecting and handling more laboratory specimens than ever before in support of clinical trials. Laboratory procedures continue to increase in complexity because personalized medicine and customized drug development rely on robust biomarker and genetic data. Highly specialized assays require more customized specimens which often require added processing and more critical procedures for controlled handling. A greater number of biomarkers included in today’s protocols also require more sample aliquots to be created and managed. Taken together, this higher complexity translates to more work for the sites and more opportunities for errors in sample collection, processing, packaging and shipping. One lost or non-viable sample can hamper the ability to enroll a subject in a clinical trial or include data from an enrolled subject in the regulatory submission.
In this 4-part series, attendees will gain new insights and learn best practices from technical and scientific experts on ways to accelerate clinical trials to meet objectives faster. This webinar will address concerns regarding the speed and efficiency of labs involved in complex studies and provide solutions to ensure that they are not getting bogged down. The experts will discuss methods for ensuring that labs are moving fast enough to meet the needs of the patients whose lives depend on them.
Register now to learn more about how to accelerate clinical trials by addressing the challenges of sample collection and sample accuracy.
Kristine Kuryla, Vice President, Project Management, LabConnect
Kristine Kuryla brings three decades of central laboratory experience with prior leadership roles in global project management, data management and clinical trials information systems. Kris’s research interests include neurology, oncology and infectious diseases. In her current role, she is responsible for the oversight of central lab project management services offered by LabConnect, aligning project service strategy to patient care, investigator site support and client needs while ensuring excellence in project delivery. She served as the Chair for the Western New York Chapter of the Association of Clinical Research Professionals (ACRP) from 2011-2017.
April Peltier, Director, Clinical Trial Materials, LabConnect
April Peltier has been with LabConnect for 2 years. She brings global cross-industry production experience in life sciences, aviation and automotive to our team. She holds an MBA from King University in Bristol, TN, and has specialized training in production, lean process design, implementation and sustainment, project management, marketing, and sales. She aspires to acquire her DBA in leadership to continue to grow personally, and to give back to her community.
During her time with us she redesigned the production flow process for improved efficiencies and throughput for our kit build operation. April and her team have worked to strengthen supplier relationships enabling us to deliver clinical trial kits faster, with high quality standards. Over the past two years April and her team have increased clinical trial kit production by >60% to meet growing business needs. She is also a key leader in starting our kit building operations in the Netherlands as we continue to grow our global footprint.
April and her team are committed to carrying out the noble LabConnect mission: We create healthier communities by accelerating the development of new medicines for patients around the world.
Neha Mohun, Project Manager, Project Management (PRM), LabConnect
Neha Mohun is a clinical trial project manager with over 15 years of experience in the medical field ranging from pediatric endocrinology, neurology, ENT/facial plastic surgery to dermatology. Neha currently works as an Operational Project Manager overseeing clinical trials from initiation to close out. While excelling in project planning and execution, Neha continues to exceed expectations set forth by her sponsors. Prior to joining LabConnect, Neha worked as a clinical trial coordinator at an independent investigative site that has been nationally recognized for high enrollment and quality data. Neha has demonstrated skills in clinical data management, operations management, operations development & implementation and medical compliance.
Taylor Byram, Biology, Project Manager, LabConnect
Taylor Byram has been working in the research industry contributing over eight years’ experience managing teams, providing leadership and solutions to maximize company values. She employs a systematic and analytical approach to problem-solving with demonstrated ability to manage projects from initiation through execution/completion within fast paced, time-sensitive environments. Taylor worked with sites as a lab director and study coordinator before making the shift to project management in order to maximize change effectiveness with clear and defined milestones that effectively communicate benefits to clients. She is striving to push the boundaries of healthcare through research.
Who Should Attend?
- Senior professionals working in Translational Medicine
- Clinical Operations Team Managers and Executives
- C Level Managers
What You Will Learn
Attendees will learn about relevant ways to support:
- Translating their complex protocol to the simplest possible specimen collection kits for site convenience
- Designing streamlined kits to minimize site storage requirements
- Identifying the optimal strategy for supplying materials in central lab kits vs. site-procured materials
- Reducing waste from unused kits
LabConnect improves lives by partnering with pharma/biotech companies and clinical research organizations (CROs) to accelerate the development of medicines around the world. An independent, global, one-stop-shop focused on delivering central laboratory services that are tailor-made, timely and flexible to meet the evolving study demands of traditional and increasingly complex trials. With deep and unmatched experience, LabConnect’s team of scientific experts serves as an extension of our clients’ clinical teams, quickly coordinating all laboratory related needs and providing end-to-end analytical and logistical solutions.
Leading the evolution in central laboratory services since 2002, our services are tailored to fit the unique needs of your trial. Connect with us at www.labconnect.com or via email at [email protected].