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Benefits of PSI Global Support for Chinese Biotech Sponsors  

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Deciding where to run your study can determine the success of a trial; from meeting patient enrollment and providing a positive patient journey to ensuring site expertise and a broad eligible patient population, choosing the right sites and countries to run clinical trials is crucial.

For Chinese biopharma companies sponsoring global trials, the US is an obvious choice for running clinical trials due to the ability to collect vast amounts, and in some cases, the majority of study data, very quickly and in one place. In addition, the US is often a top choice for smaller biotechs seeking potential investors due to the visibility of trials.

However, sponsors should also consider the benefits of adding European countries to their geomix. Because many European countries have startup timelines similar to the US, adding these sites can further enhance overall timelines due to faster recruitment over a wider geographical area with additional patient populations.

PSI is a full-service CRO based in Switzerland that’s ready to support your global clinical trials with over 3,000 team members across 55 countries, spanning Asia, Europe, Africa, and the Americas. PSI has been continually recognized for excellence, including receiving CRO Leadership Awards in the categories of Expertise, Quality, and Reliability* for the past six years in a row.

Below are some additional ways PSI can provide support for Chinese sponsors as you plan your next trial:

  • Minimizing your budget: Many countries in Europe may be less expensive to run trials, with timelines just as fast as US sites. PSI uses VISIONAL™, our advanced feasibility tool, to harness the power of machine learning to provide accurate enrollment forecasting, comparing hundreds of country and site combinations and their probability of success within just a few minutes.
  • Overcoming regulatory hurdles: With our expansive European footprint and local teams, PSI can assist in navigating language and regulatory concerns such as data privacy (GDPR) from the European Union that may impact data robustness across international lines. Our regulatory experts in US and Europe have successfully supported more than 20 drug approvals in the last five years.
  • Trial design and protocol review: Designing clinical trials with the patient journey in mind and providing a plan for globalizing a trial is crucial to mitigate slowdowns further in the process. PSI’s Scientific Advisory Board can help sponsors gather detailed feedback on the overall trial design and protocol to minimize protocol amendments down the line.
  • Facilitating startup and recruitment: PSI’s Patient Recruitment and Site Support Specialists, along with our extensive vendor and site relationships, ensure tailored startup and enrollment plans at every site, especially when managing patient recruitment materials.
  • Ensuring the quality of clinical data: PSI strictly follows Good Clinical Practice (GCP) principles to run clinical trials, ensuring high quality clinical data as well as the protection of subjects. We exhibit validated quality with more than 130 FDA and EMA inspections to PSI sites, with additional successful inspections this year.

Click here to learn more about how PSI provides global support for biotechs around the world. Contact us today to schedule a meeting at ChinaTrials 15 or an introductory call with PSI about how to take your trial to the next level.

* Overall (combined Big and Small Pharma) respondent group.

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ASH 2023: PSI Team Spotlight

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ASH 2023 is coming up December 9 – 12, and our team is excited to join the conversation with hematology sponsors and partners like you. Stop by Booth #3352 for a chance (or schedule a meeting here) to speak with PSI experts helping to support hematology-oncology and hemophilia innovators across the globe. Meet our team members who are packing their bags for San Diego.

Vince Calderon
Director Project Management

Vince serves as a Director and supervisor of Project Management, overseeing PSI’s team of Project Management staff and several studies in oncology and hematology. Vince has been with PSI since December 2019, and is based in Texas. He has over 19 years’ clinical research experience, 15 years of project management experience, and has delivered 20+ oncology studies in both solid tumors and hematology-oncology.

Vince has professional affiliations with the Project Management Institute in the US and has been a certified Project Management Professional since 2012.

Rhonda Critchlow with teal circle border
Meet Rhonda

Rhonda Critchlow
Senior Director, Operations

Rhonda Critchlow, Senior Director of Therapeutic Strategy, currently oversees all of PSI’s core indications, and specializes in operational strategy within oncology and radiopharmaceuticals. With over 25 years of research experience, she provides valuable leadership and management working both regionally and globally.

Overseeing the therapeutic strategy department, which includes our Site Support Specialist, Rhonda brings guidance and oversight to specialty vendor management, patient recruitment and retention for our sponsors.

Prior to working at PSI, her experience includes working within oncology research as a Coordinator and Director, CRA, Clinical Trial Manager, Head of Monitoring and Vice President of Early Phase Oncology before joining PSI. Rhonda also has experience working with general radiology and nuclear medicine in large hospital organizations, providing valuable input for clinical development, study management and operational considerations.

Colleen Ring
Associate Director, Feasibility

Colleen Ring, PhD, Associate Director, Feasibility, has worked in the clinical research industry for the past 12 years. Prior to transitioning to the clinical research field, Colleen was a senior research scientist, specializing in multiple signaling pathways (e.g. TGFb, Tyrosine Kinases, Rho/Rac GTPases) across a broad range of areas, including oncology. As a leader within PSI’s global feasibility team, Colleen specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecasting that models and compares hundreds of country and site combinations, their budgets and probability of success, Colleen develops recommendations for optimized enrollment in line with each sponsor’s key objectives.

As an Associate Director, Colleen provides leadership for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Meet us at ASH 2023

Vince, Rhonda, Colleen, and the rest of our team are excited to discuss your upcoming oncology study at ASH 2023. Click here to reserve your spot today.

If you would like to work with PSI as an investigator, submit an inquiry through our contact form here.

SNMMI 2023 Annual Meeting: PSI Team Spotlight

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The SNMII 2023 Annual Meeting is coming up June 24 – 27, and our team at PSI is excited to join the conversation with nuclear medicine and molecular imaging sponsors and partners like you. The team will be walking the floor, ready to speak with you about your upcoming study. Schedule some time to speak with PSI experts helping to support innovators across the globe. Meet two of our experts packing their bags for Chicago below!

Dylan Stoy with pink circle border
Meet Dylan

Dylan Stoy
Associate Director, Therapeutic Strategy

Dylan Stoy, PSI’s Therapeutic Strategy Director, is dedicated to conducting and executing better clinical studies in PSI’s core therapeutic areas. Dylan has worked in radiopharmaceutical research for about 9 years, with research interests in targeted drug delivery systems and optimizing the conduct of studies. Dylan has overseen radiopharmaceutical research from various roles including onsite research, design and trial conduct, clinical operations oversight, project management, and therapeutic strategy.

Dylan and his team are devoted to making participation for sites and patients in complex radiopharmaceutical studies more attainable and ensuring that PSI teams are highly trained and equipped to handle any challenges your program might encounter. Dylan works closely with the core business units within PSI, overseeing research throughout the study lifecycle, providing strategic leadership to our teams and collaborators (both internally and externally), and delivering corporate-wide trainings to make PSI your full-service CRO for all things radiopharmaceutical development.

 
Wes Ross with teal circle border

Wes Ross
Site Support Specialist

Wes Ross, Site Support Specialist, is one of PSI’s keys to addressing the complexities that lie in the conduction of radiopharmaceutical trials. Wes has a BS in Radiologic Sciences and an AS in Radiology and is also a licensed nuclear medicine technologist with over 22 years of hands-on experience working in the field. He has worked as a nuclear medicine technologist, working on the development and oversight of nuclear medicine research, and has worked in the creation of testing and controls for digital PET/CT technology. Wes uses his breadth of experience to drive PSI ahead of the curve for conducting successful research in the industry, developing new and exciting ways to get radiopharmaceutical studies up and running.

Wes manages the site qualification process for imaging studies and manufacturing radiopharmaceutical products, oversees the process of image acquisition and quality control, and is responsible for training trial sites, project teams, and vendors to deliver meaningful research in the requirements and strategies for the programs he works on. Wes works closely with other core units both within PSI and sponsor companies, such as project management, clinical operations, CMC, and supply chain to help design studies, project plans, and training materials in the radiopharmaceutical space.

Meet us at SNMMI 2023

Dylan, Wes, and the rest of our team are excited to discuss your upcoming study at SNMMI 2023. Click here to reserve your spot today.

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ASCO 2023: PSI Team Spotlight

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ASCO 2023 is coming up June 3 – 5, and our team at PSI is excited to join the conversation with oncology sponsors and partners like you. Stop by Booth #19020 for a chance (or schedule a meeting here) to speak with PSI experts helping to support oncology innovators across the globe. Meet our team members who are packing their bags for Chicago.

Vince Calderon with teal circle border

Vince Calderon
Director Project Management

Vince serves as a Director and supervisor of Project Management, overseeing PSI’s team of Project Management staff and several studies in oncology and hematology. Vince has been with PSI since December 2019, and is based in Texas. He has over 19 years’ clinical research experience, 15 years of project management experience, and has delivered 20+ oncology studies in both solid tumors and hematology-oncology.

Vince has professional affiliations with the Project Management Institute in the US and has been a certified Project Management Professional since 2012.

Emily Mcinturf with pink circle border

Emily McInturf
Director, Feasibility

Emily McInturf, Director Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives.

As a Director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Rhonda Critchlow with teal circle border
Meet Rhonda

Rhonda Critchlow
Senior Director, Operations

Rhonda Critchlow, Senior Director of Therapeutic Strategy, currently oversees all of PSI’s core indications, and specializes in operational strategy within oncology and radiopharmaceuticals. With over 25 years of research experience, she provides valuable leadership and management working both regionally and globally.

Overseeing the therapeutic strategy department, which includes our Site Support Specialist, Rhonda brings guidance and oversight to specialty vendor management, patient recruitment and retention for our sponsors.

Prior to working at PSI, her experience includes working within oncology research as a Coordinator and Director, CRA, Clinical Trial Manager, Head of Monitoring and Vice President of Early Phase Oncology before joining PSI. Rhonda also has experience working with general radiology and nuclear medicine in large hospital organizations, providing valuable input for clinical development, study management and operational considerations.

Meet us at ASCO 2023

Vince, Emily, and the rest of our team are excited to discuss your upcoming oncology study at ASCO 2023. Click here to reserve your spot today.

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