Contact
Submit RFP

Paul Mirek

downtown chicago at night over the river

DDW 2023: PSI Team Spotlight

Leave a Comment / Events / By

Digestive Disease Week 2023 is coming up May 6-9, and our team at PSI is excited to join the conversation with IBD and GI sponsors and partners like you. Stop by Booth #4511 for a chance (or schedule a meeting here) to speak with PSI experts helping to support IBD innovators across the globe. Here’s a closer look at two of our team members who are packing their bags for Chicago.

Alex Gilfanov
Project Director, Project Management

Dr. Alex Gilfanov, M.D., Project Director, has worked in the clinical research industry since 2006, including thirteen years with PSI. Specializing in gastrointestinal (GI) trials for the last seven years, he is responsible for supervising multiple large Crohn’s disease and ulcerative colitis programs.

As a project director, Alex provides general study supervision for investigators, sponsors, vendors, and functional departments at PSI, focusing on critical processes.

During his career, Alex has served in different roles across the clinical trial process, including treating physician, sub-investigator, and monitor, before managing and supervising clinical trials for the last 10+ years. This breadth of experience allows him to better understand the needs of patients and caregivers as well as all other stakeholders involved in clinical trials. A frequent guest at Digestive Disease Week, European Crohn’s and Colitis Organization Congress, United European Gastroenterology Week, and other large GI congresses, Alex is passionate about exploring all the current developments in gastroenterology to better understand the latest treatment options available to patients as well as the challenges they face along the way.

Heather Thompson
Site Support Specialist

Heather Thompson, Site Support Specialist, is focused on helping PSI to meet the growing demand for technical and operational expertise in gastroenterology in clinical research. A board-certified nurse practitioner with more than 15 years of gastroenterology experience (focused heavily on Crohn’s disease and ulcerative colitis), she has provided a wide range of patient-centered gastroenterology care in outpatient, emergency department, and inpatient settings and primarily managed a large population of inflammatory bowel disease patients (most of which were on biologic therapy), including routine office visits, medication selection, tracking laboratory testing, and procedure follow-up to track patient progress and disease progression/remission. She also has five years of experience conducting training, discussing disease processes, and providing education on clinical trials for the medical community. She served as the regional nurse practitioner speaker in the pharmaceutical industry from 2017 to 2022, focusing on biologic therapy.

Heather assists Project Management with study design and the creation of manuals, training materials, and study forms, as well as presenting at Investigator Meetings. Throughout the study, she is responsible for developing technical project tools, including site and project team training tools; identifying and tracking critical project issues; and assisting assigned CRAs with technical issues. Heather utilizes her clinical knowledge in working with multiple departments across the study lifecycle and is a critical resource for scientific and operational expertise to our Business Development, Project Management, and Clinical Operations Departments.

Meet us at DDW 2023

Alex, Heather, and the rest of our team are excited to discuss your upcoming IBD study at DDW 2023. Click here to reserve your spot today.

PSI Publishes New Report on the Future of Oncology Clinical Research

Leave a Comment / News article / By

PSI CRO AG, a full-service global CRO specializing in pivotal Phase 2 and 3 trials for oncology, hematology, and other select therapeutic areas, has published a new report on the current landscape of oncology research and its impact for future trials. Preparing for the Future of Oncology Clinical Research, co-authored by PSI’s Dr. Maxim Kosov, Senior Medical Advisor, Operations, and Dr. Victor Zenzola de Toma, Medical Monitor, provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Preparing for the Future of Oncology Clinical Research cover

Kosov and Zenzola de Toma reviewed data from over 2,200 poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting to develop the comprehensive overview. Topics include:

  • General trends in oncology, including insights into concomitant medications’ impact on immune checkpoint inhibitors and emerging biomarkers such as ctDNA
  • Therapeutic advances in the most challenging indications, including “HER2-low” breast cancer and resectable stage IIIA NSCLC
  • Additional research highlights in gastrointestinal, gynecological, and genitourinary cancers as well as pediatric oncology and rare disease

“Oncology studies face unique challenges due to their expansive geographic footprints, lengthy screening and treatment durations, and massive amounts of clinical data,” said Dr. Kosov. “As the need for oncology clinical trials persists and grows, PSI CRO is committed to keeping abreast of the latest scientific advances and partnering with the companies and investigators doing the most exciting work across the wide range of oncology diseases.”

For the past 25 years, PSI CRO has worked with sponsors to advance their research in oncology by proactively cultivating long-term relationships with sites around the world and applying advanced technology for data-driven feasibility and enrollment forecast, including through its proprietary technology platform, INTELIA™.

VISIONAL™, the latest addition to the platform, allows project managers and sponsors to model and compare hundreds of country and site combinations, their budgets and probability of success within just a few minutes. In the end, it recommends the most optimal enrollment scenario in line with sponsor key objectives.

Preparing for the Future of Oncology Clinical Research is available now. For more information about how PSI plans and executes seamless oncology clinical trials with novel designs, click here.

PSI CRO Announces Launch Of VISIONAL™ Study Modeling Tool

Leave a Comment / Press Release / By

ZUG, SWITZERLAND, September 29, 2022  – PSI CRO AG announces the launch of VISIONAL™, a study modeling tool that is part of the company’s proprietary technology platform, INTELIA™, used for clinical trial planning, budgeting and tracking of clinical trial finances.

“Now, more than ever, biotech sponsors need to see study budgets that are realistic, reliable, and predictable. Sponsors are tired of CROs change-ordering them at every turn, and CROs need to improve their predictions of what it would take to complete a clinical trial on time,” says Alla Smyshlyaeva, PSI’s Senior Director of Proposals. “With the help of leading software development company DataArt, we have created a technology platform that offers a suite of study planning tools and is indispensable to the efficient planning of global pivotal clinical trials.”

VISIONAL™ HELPS ACCURATELY PREDICT STUDY ENROLLMENT TIMELINES

VISIONAL™ , the latest addition to PSI’s INTELIA™ platform, is a machine-learning-powered system for data-driven feasibility and enrollment forecast. It models and compares hundreds of country and site combinations, their budgets and probability of success within just a few minutes. In the end, it recommends the most optimal enrollment scenario in line with sponsor key objectives

PSI-CRO-Visional-Study-Modeling-Tool

HOW IT WORKS

VISIONAL™ is a cloud-based module that integrates and processes feasibility data tailored to a specific protocol, taking into consideration local medical practices, available patient populations, clinical trial experience, and other variables.

It collates historical enrollment rates in the given patient population from both internal and external data sources.

VISIONAL™ integrates historical startup timelines across more than fifty countries where PSI operates, as well as specific site knowledge data.

Sophisticated constraint-based algorithms are then applied to these data sets to model hundreds of country- and site-specific enrollment combinations to find the ideal scenario. Within minutes, clients have access to:

  • the fastest possible patient enrollment scenario
  • cost-effective enrollment options
  • optimal patient enrollment scenarios that balance out associated costs and study duration

VISIONAL™ can also be used to validate the client’s requested specifications, to estimate probability of success for the expected scenarios, and to recommend alternatives.

IMMEDIATE AND LONG-TERM BENEFITS

  • Modeling Beyond Human Abilities VISIONAL™ is extremely fast: it has the capacity to model and compare hundreds of possible enrollment scenarios and suggest the most optimal scenario within only a few minutes

  • Predictions without Human Errors and Bias VISIONAL™ de-biases enrollment projections: scenarios are automated and data-driven

  • Probability Projections VISIONAL™ estimates the probability of enrollment projections using historical data

  • Up-to-date Algorithms VISIONAL™ is up to date: the algorithms are based on the latest data and are being “retrained” on an ongoing basis to capture the latest insights

  • Live Budget Simulations VISIONAL™ incorporates costs in the decision-making process

“We are very excited about VISIONAL™,” says Kasia Moscicka, Global Head of Feasibility Department at PSI. “Reliable planning of clinical trials has always been PSI’s core expertise. Now, with the addition of this powerful tool, we are fully equipped to produce highly dependable, protocol-specific enrollment scenarios that consider the many intrinsic strategic needs of our customers.”

ABOUT PSI’S INTELIA™

INTELIA™ is PSI’s proprietary cloud-based platform created with the help of a leading global software development company DataArt.

The platform brings together a suite of clinical trial planning tools:

  • VISIONAL™, study modeling tool

  • CLARITY™, study budgeting and forecasting tool

  • CADENCE™, study budget tracking tool

  • INSITE™, investigator grant calculator

ABOUT PSI CRO

PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors.

Global headquarters are based Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com

For Media Inquiries:

Ashley Stufano, Marketing Specialist

919-972-9572 | ashley.stufano@psi-cro.com

How to Boost Patient Enrollment in a Global IBD Trial

Case Study / By

For one of the largest-ever global IBD trials, we knew our sponsor’s success depended on identifying the right sites and keeping them engaged.

Click to read How a Global IBD Program Boosted Enrollment & Strengthened Site Relationships Partnering WIth PSI CRO

Download the case study as a PDF.

Details:

Therapeutic Area: IBD

Geography: 40 countries

Sites: 400

Patients: 800 (planned)

Current Status:

  • Patient enrollment on schedule
  • PSI is on track to enroll 500 patients by year-end

How to Engage Investigators & Patients in the Highly Competitive IBD Landscape

After a large pharmaceutical company delivered enrollment 60 days ahead of schedule for a Phase 2 inflammatory bowel disease (IBD) study with PSI CRO, the sponsor faced a new challenge: one of the largest-ever IBD programs in the same indication. Competition for IBD patients is fierce, and we knew success depended on not only identifying the right sites but also keeping them engaged throughout the duration.

The sponsor engaged PSI to manage 400 sites and enroll 800 patients across 40 countries. With the length and size of the study, many sites went silent after the initial excitement. The onset of the COVID-19 pandemic introduced a whole new set of extraordinary challenges, which was especially noticeable during the summer months – already a typically slow period, but also when many countries implemented additional restrictions to slow the spread of new variants that made enrollment even more difficult.

To re-energize the study team and keep enrollment on track, the sponsor introduced a new incentive campaign with PSI modeled after the Summer Olympics to foster a sense of friendly competition.

3 Steps to Empower Your Sites

  1. Create a compelling, inclusive campaign to motivate sites

PSI divided the study teams to stand for their respective countries and introduced the following scoring system:

  • Gold medal: Awarded for every subject randomization
  • Silver medal: Awarded for every subject screening
  • Bronze medal: Awarded for every subject rescreening

The project team developed creative materials and branding to engage the teams during the campaign and made sure that countries of all sizes stayed visible within the competition thanks to an averaged rating system.

  1. Invest time into building close relationships with the site teams

To be truly patient-centric, a CRO needs to first be site-centric. Our mission is to make the site’s life in clinical trials as trouble-free as possible. It’s not easy, because clinical trial protocols are typically overcomplicated by all sorts of requirements that add work to the site staff already exhausted by routine medical practice. That’s why we are focused on building site support processes, working closely with the site staff to prevent and fix any signs of screening and enrollment delays.

PSI works carefully with each investigator to increase the percentage of patients entering the study, providing training and resources so the site teams understand the best moment to screen patients for the study and that screen failure patients could be reassessed. The project team provides extra support to sites and patients with personal protective equipment, implements additional procedures for direct shipment of the drug to patients’ homes, identifies a big network of local labs to minimize trips during the pandemic, and arranges comfortable and safe conditions for patients’ travel or travel reimbursement.

  1. Build on a long-standing partnership

With the same leadership team in place since 2015 for the program, including the same Global PM and Co-Manager from the Phase 2 Study, the PSI teams draw on their experience from previous studies for this client during the competition. PSI Country Managers and Clinical Operations colleagues are also engaged to help the project teams come together to meet a common goal. It’s great to have a stable global team on such a complex project.

Sign up for more IBD insights from PSI CRO.

 

Best Places to Work 2022: PSI CRO Honored for Fourth Year in a Row

Leave a Comment / News article / By

As one of Philadelphia Business Journal’s Best Places to Work for 2022, PSI CRO has once again earned recognition for its company culture, leadership, and values as voted on by its employees. This is the fourth year in a row that PSI’s King of Prussia team has been honored with this award.

The Business Journal partnered with Quantum Workplace to identify Greater Philadelphia’s Best Places to Work. Companies are first nominated by the public, and employees at those companies are then asked to complete an online survey measuring the company culture and taking into consideration compensation, benefits, and trust in senior leadership.

Winning in this region is no small feat. King of Prussia is home to several of the top clinical research, healthcare, and biotech companies. In total, this year’s list includes 76 companies from across the region.

“The way many of us work has been fundamentally altered over the past two-plus years.” says Philadelphia Business Journal Associate Editor Lisa Dukart. “As work – and where we work – continues to evolve, one thing remains constant: Employees want to work for companies whose values and culture align with their own.”

Culture is something we take very seriously, both in King of Prussia and across the globe. PSI is privately owned by a group of managers who created it a quarter of a century ago and still come to work every day. This stability has helped nurture the global PSI culture that unites us across six continents.

Seven core values guide the way we do business:

  • Delivering Wow Service
  • Being a Teammate
  • Practicing Accountability
  • Delivering Results
  • Excelling in Communication
  • Being Excellent & Humble
  • Staying Lean

As we continue to grow each day with more than 2,600 employees around the world, these values help ensure that PSI remains on the unique path of organic growth and dedication to customer service that we’ve followed for more than 25 years. To learn about each of our values and see how you can join the growing PSI team, visit our Careers page.

Strategies for Expediting Study Startup in Australia With Barrie Koh

Leave a Comment / Case Study, Video / By

Did you know that Phase 2 and 3 study startup times in Australia can be expedited with the right site relationships? In order to accelerate the first patient in, PSI engages private sites and medical centers to ensure an average startup timeline of only five months. Learn more about study startup in Australia with Barrie Koh, Country Manager.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, I’m Barrie. Did you know that Australia is quick to start up?

Everyone in the industry knows that it is easy to get an approval for an early-phase study in Australia. It is supported by streamlined regulatory processes, and you just need fewer documents for submissions. What most don’t realize is that startup in Phase 2 and Phase 3 isn’t that different.

The challenge is that most clients have a habit of going back to the same key opinion leaders or the huge institutions. they have lots of studies and they are heavily bureaucratic. To get to the first patient in quickly, PSI has been engaging the private sites, which are much more agile, only working with four to five huge private medical centers and a dozen more smaller sites.

With this particular approach, five months is feasible and it is consistent across all phases, all therapeutic areas and drugs classes. To cite you an example, in a recent microbiome study, we actually managed to achieve the first patient in in five and a half months at a private site down in Sunshine Coast. And this came in two weeks ahead of our planned first patient in.

Another example is a gene therapy study that we’re currently running. We were the first CRO to apply for a gene therapy license (in Australia). So we actually worked with each other to try to move this forward and this was done under four months itself and ever since then, we’ve completed four more gene therapy studies.

PSI Named a 2022 CRO Leadership Award Champion in Three Categories

Leave a Comment / News article, Press Release / By

Leading full-service, global CRO continues record of success with awards in all five core categories for the fourth year in a row

PSI CRO, 14 JUNE 2022 – PSI CRO, a leading full-service, global contract research organization (CRO), has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is also the fourth year in a row in which PSI CRO received CRO Leadership Awards in all five categories, also including Expertise and Capabilities, across two respondent groups.

The CRO Leadership Awards are presented by Life Science Leader and Clinical Leader based on research conducted by ISR Reports. For 2022, 50 contract research organizations were assessed on 20+ performance metrics in five core categories in ISR’s annual CRO Quality Benchmarking survey. Winners in these categories are judged by their customers as having exceeded their expectations. Those companies that scored one standard deviation or more above the weighted average in each of the core categories are also recognized as the top performers or Champions.

“ISR’s stringent screening process ensures that only highly qualified industry decision-makers participate in our CRO benchmarking market research,” says Kevin Olson, CEO of Industry Standard Research. “This is paramount as we ask the research participants to provide experiential, not perceptual, feedback on their involvement with contract suppliers over the past 18 months. The data enable users of ISR’s market research to make confident business decisions based on the experiences of their industry peers.”

When the CRO Leadership Award Champion Awards were presented in 2021, PSI was named a Champion in the category of Expertise. The company has received leadership awards in the same five categories across both respective respondent groups since 2019 and also earned four awards in 2018.

“Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors,” says Nick Sinackevich, President of PSI. “Our continuing success in the CRO Leadership Awards is an important benchmark for this goal and a testament to the tireless work of our teams around the world.”

About PSI: PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors. 

Global headquarters are located in Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com

For Media Inquiries:

Ashley Stufano, Marketing Specialist

919-972-9572 |ashley.stufano@psi-cro.com

“One Huge Night” for Patients and PSI: The Gift of Life Gala

Leave a Comment / News article / By

Last week, we were honored to receive the 2022 Corporate Partner Award from the Gift of Life Marrow Registry at its annual One Huge Night Los Angeles Gala at the SLS Hotel in Beverly Hills. In addition to raising funds for the organization, the Gift of Life Gala offers a chance for transplant recipients and their donors to meet in person for the first time.

At PSI CRO, we are guided by a simple, straightforward calling: every patient counts. We’re proud of our longstanding partnership with Gift of Life, a national, public, not-for-profit registry facilitating peripheral blood stem cell and bone marrow transplants for patients in the United States and abroad.

Rhonda Critchlow, PSI CRO’s Senior Director, Operations, and Jeremie Braun, Senior Director, Business Development, were in attendance to accept the award, and more importantly, to meet with the people who make the Gift of Life’s mission possible.

Jeremie was instrumental in connecting PSI to the Gift of Life organization through his involvement in the Hope4Adam campaign in 2016.

The award was presented to Jeremie and Rhonda by Jay Feinberg, Gift of Life’s founder and Chief Executive Officer as well as a 26-year transplant survivor. “It is an honor to play a small part as a corporate partner when we know we are saving lives,” said Rhonda. “PSI will remain committed to Gift of Life and the important work you are doing.  I challenge all of my friends to take up the battle – by doing something so simple as joining the registry with a cheek swab, which ultimately can turn into saving a life.”

Rhonda and Jeremie at One Huge NightAbout Gift of Life

Gift of Life is accredited by the World Marrow Donor Association and is a member of the global registry, Bone Marrow Donors Worldwide. Joining the registry is simple: it requires a mouth swab, making it simple for anyone to help save lives.

The Gift of Life headquarters in Boca Raton, Florida, has been servicing donors and patients alike since 1991. The state-of-the-art apheresis center, which opened in 2019, has made it  convenient for donors to donate stem cells in a relaxing and spa-like facility, and PSI is grateful to be able to sponsor a collection chair at the center to make donors comfortable during the process.

PSI CRO: A Proud Partner for Patients

From the beginning, PSI has worked alongside Gift of Life to gather cheek swabs at conferences like ASH and ASCO, and inspire global employees to get involved during World Marrow Donor Day, held annually on the third Saturday of each September.

But the partnership isn’t exclusive. To meet the needs of patients around the globe, raising more awareness is imperative. Corporate partners aren’t just appreciated at Gift of Life, they’re celebrated.

If your company is dedicated to patients and passionate about saving lives, you, too, can partner with Gift of Life, and help find matches for patients like Aiden, who is fighting a rare blood disorder right now.

How to Apply for Phase 1 and Phase 3 Studies in China at the Same Time With Lisa Lu

Leave a Comment / Case Study, Video / By

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Hear Lisa Lu, PSI CRO’s Country Manager in China, discuss how to determine if your study may qualify and how PSI’s local experts can help.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hello, my name is Lisa Lu. I’m the country manager for PSI in China and I’m located in Shanghai. Let me share with you some relevant aspects for running clinical trials in China.

Did you know that for new drugs coming to China, it is needed to conduct a PK study in a Chinese population locally? One can apply for an IND for Phase 1 and Phase 3 studies at the same time.

Based on NMPA’s feedback, you can potentially run Phase 1 and Phase 3 studies in parallel. Urgent medical needs like hematology studies, and lethal diseases without any drugs available at the moment, have a higher chance in running Phase 1 and 3 studies at the same time.

Usually, a PK study needs 20 to 30 healthy volunteer subjects or patients, depending on the different indication and medicine.

How Do India Study Startup Timelines Compare? With Radhika Bobba

Leave a Comment / Case Study, Video / By

How did we achieve site activation for a radiopharmaceutical study in India in less than 5 months? It turns out India study startup timelines are faster than many European countries.

Learn more in this video with Radhika Bobba, PSI CRO’s Regional Director, India and Far East Country Management.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

India startup timelines are always discussed. “India is so slow, it’s so difficult to set up a study, it’s so difficult to start a study.” Let me give you a recent example.

We submitted a dossier for a radiopharmaceutical molecule in oncology on the 3rd of August, 2021. We received approval for this particular dossier on the 2nd of December, 2021 from a regulatory authority, the DCGI. It took us five months. The first site was initiated on the 14th of December, 2021, and the same site was activated on the 28th of December, 2021.

5 months, is it so long?

Yes, we are definitely not the fastest. We are definitely not the slowest. We can be compared to other countries in Europe. We can be compared to France, Italy, Germany, Switzerland. We are faster than Romania.

Subscribed? Manage your subscription

© PSI, 1995 - 2023. All Rights Reserved.