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PSI Receives Four More CRO Leadership Awards in 2024

Seventh consecutive year of recognition for Swiss-based global CRO based on research conducted by ISR Reports

PSI CRO, 13 May 2024 — PSI CRO, a leading full-service, global contract research organization (CRO), has received CRO Leadership Awards in the categories of Expertise, Quality, Compatibility, and Reliability in the Overall (combined Big and Small Pharma) respondent group. 2024 marks the seventh consecutive year that PSI has received leadership awards as presented by Clinical Leader and Life Science Connect based on research conducted by ISR.

For the 2024 awards, ISR assessed 42 contract research organizations on over 20 performance metrics in five core categories in its annual CRO Quality Benchmarking survey. Survey respondents evaluated only those companies with which they worked on an outsourced project within the previous 18 months to ensure survey responses are based on actual involvement with CROs and clear experiential data.

PSI has received CRO Leadership Awards in multiple categories each year since 2018.

“Each year, PSI looks to the results of the CRO Leadership Awards as one indication of success in our ongoing mission to be the best clinical research organization in the world as measured by our employees, clients, investigative sites, and vendors,” said Nick Sinackevich, President of PSI. “We are only as good as our last performance, if that. Our continuing recognition by our sponsors speaks to the unwavering commitment to excellence that defines PSI.”

“For 12 years, Life Science Connect has been working alongside ISR Research to develop our annual CRO Leadership Awards. It’s a big endeavor that provides essential data to any size sponsor seeking help with the daunting task of finding the right CRO partner for their clinical studies,” said Dan Schell, Chief Editor, Clinical Leader. “Receiving one of these awards is testament to a company’s relentless pursuit of providing the highest standard of service to the clinical research industry, and we congratulate the winners on all their hard work.”

To learn more about ISR Reports and the research behind the CRO Leadership Awards, please visit ISRreports.com.

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 Collins, Marketing Specialist

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

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Clarity and PSI Kick Off SAR-bisPSMA Phase III

PSI CRO, 26 October 2023 — Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG (“PSI”), a global contract research organisation committed to on-time enrollment in radiopharmaceutical clinical trials, have entered into an agreement and have commenced work towards Clarity’s Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY (NCT06056830)1.

CLARIFY derives from “Positron Emission Tomography using 64Cu-SAR-bisPSMA in participants with high-risk prostate cancer prior to radical prostatectomy: A prospective, single-arm, multi-centre, blinded-review, Phase III diagnostic performance study”. It is a non-randomised, open-label clinical trial in 383 participants.

The aim of the Phase III trial is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect prostate cancer within lymph nodes located in the pelvic region. Evaluation will take place over 2 imaging timepoints, Day 1 (day of administration) and Day 2 (approximately 24 hours post administration). CLARIFY is expected to begin recruitment in late 2023.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to move one step closer to initiating our first registrational Phase III trial. With recent positive and valuable guidance from the US FDA in relation to our 64Cu-SAR-bisPSMA program, we look forward to commencing recruitment into the CLARIFY trial shortly and to gathering more data on this next-generation product to confirm the compelling preclinical and clinical trial results to date.

“The positive results from our completed PROPELLER2 trial showed that 64Cu-SAR-bisPSMA is safe and its uptake in PSMA-expressing cancer lesions was significantly higher compared to an approved standard-of-care PSMA imaging agent for prostate cancer in Australia and the US. This may enable diagnosis of additional and smaller lesions, which we observed in our PROPELLER2 trial, and we are eager to investigate the further benefits of delayed imaging, particularly in this patient population, a characteristic not available to the first generation of PSMA diagnostic agents. Furthermore, we believe that the additional shelf-life of up to 48 hours will not only allow clinics greater flexibility in scheduling of the scans, but also improve patients’ access to care in clinics and geographic areas where the short half-life of current PSMA PET tracers restricts the use of radiopharmaceuticals.”

PSI’s Senior Director of Operations, Rhonda Critchlow, commented, “Using our global database of over 400 radiopharmaceutical sites, we will be able to identify sites with the best resources and capabilities for the CLARIFY trial. We are excited to begin our collaboration with Clarity and will focus on the startup of high-performing sites to achieve the first patient in, in the shortest time possible. We believe that a myriad of clinical, logistical and manufacturing benefits of Clarity’s Targeted Copper Theranostics platform holds promise of improving treatment outcomes for patients with cancer and look forward to working together on achieving this important goal.”

lymph node scans
Concordant lesions on 64Cu-SAR-bisPSMA (200 MBq) and 68Ga-PSMA-11 PET/CT consistently showed higher SUVmax, SUVmean and tumor to background ratio with 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11. SUV: standardized uptake value. PROPELLER study.
Readers did not detect uptake in pelvic lymph nodes on the 68Ga-PSMA-11 PET/CT (Top). PET/CT demonstrated uptake of 64Cu-SAR-bisPSMA (Bottom) in a left pelvic lymph node according to both Readers. Prostate cancer was confirmed via histopathology. Arrows highlight the node detected on 64Cu-SAR-bisPSMA PET/CT. PROPELLER study.

About SAR-bisPSMA: SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer: Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide3. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease4.

About Clarity Pharmaceuticals: Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.

www.claritypharmaceuticals.com

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.

References

1Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study – CLARIFY. ClinicalTrials.gov ID NCT06056830.

2Lengyelova E, Wong V, Lenzo N, Parker M, Emmett L. 64Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO 2023. Poster available at: claritypharmaceuticals.com/pipeline/scientific_presentations

3Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660

4American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

For more information, please contact:

Clarity Pharmaceuticals
Dr. Alan Taylor
Executive Chairman
ataylor@claritypharm.com

Catherine Strong
Investor/ Media Relations
cstrong@citadelmagnus.com
+61 406 759 268

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icon of philadelphia skyline with five years in a row

King of Prussia Office Receives Prestigious Best Places to Work Award for 5th Year in a Row 

PSI CRO is excited to announce that its King of Prussia office has been recognized as one of Philadelphia Business Journal’s Best Places to Work for 2023. This prestigious accolade acknowledges PSI’s exceptional company culture, strong leadership, and unwavering commitment to its employees, as voted on by the dedicated professionals within the organization.   

This achievement marks the fifth consecutive year that PSI’s King of Prussia team has been honored with this esteemed award, reflecting the office’s consistent dedication to fostering an environment where employees can thrive and excel. 

“We are very proud to be named one of Philadelphia’s Best Places to Work for a fifth year in a row,” says Tom Flud, Director of Operations in PSI’s King of Prussia office. “During the last five years, PSI’s King of Prussia office has experienced substantial growth and transformation, while overcoming challenges posed by a global pandemic. Throughout this journey, our dedicated employees have continued to flourish, demonstrating unwavering resilience and a commitment to our belief that Every Patient Counts.” 

The selection process for the Best Places to Work award involves a partnership between Philadelphia Business Journal and Quantum Workplace. The public nominates companies, and employees at these nominated companies are then invited to complete an online survey that assesses various aspects of company culture, including compensation, benefits, and trust in senior leadership. 

At PSI CRO, cultivating a strong culture is a top priority, both in the King of Prussia office and across all global locations. The company’s foundation is built on stability and longevity, with a group of managers who founded PSI a quarter of a century ago still actively involved in the organization today. This enduring stability has fostered a unified global culture that spans six continents. 

The company adheres to seven core values that guide its business practices, and serve as the bedrock of PSI’s growth and unwavering commitment to providing exceptional customer service for more than 25 years. With a workforce of more than 2,700 employees worldwide, these values ensure that PSI maintains its unique path of organic growth and customer-centric dedication.  

For more information and to explore opportunities to join the dynamic PSI team, please visit our careers page

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PSI Receives Three More CRO Leadership Awards in 2023 

Global CRO continues track record of success with sixth consecutive year of awards based on research conducted by ISR Reports

PSI Receives 3 CRO Leadership Awards
PSI CRO, 7 June 2023 – For the sixth year in a row, PSI CRO, a leading full-service, global contract research organization (CRO), has received CRO Leadership Awards in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small Pharma) respondent group.

The CRO Leadership Awards are presented by Life Science Leader and Clinical Leader based on research conducted by ISR Reports. For the 2023 awards, 46 contract research organizations were assessed on 20+ performance metrics in five core categories in ISR’s annual CRO Quality Benchmarking survey. Respondents evaluate only those companies with which they have worked on an outsourced project within the past 18 months to ensure survey responses are based on actual involvement with CROs and clear experiential data.

PSI has received CRO Leadership Awards in multiple categories each year since 2018.

“At PSI, we strive to achieve global excellence, as gauged by the satisfaction of our valued employees, clients, investigative sites, and vendors,” says Nick Sinackevich, President of PSI. “We are proud to be honored in the CRO Leadership Awards for the sixth year in a row, especially in these categories that speak directly to our shared mission: delivering quality clinical trials reliably while earning the continued trust of our sites and clients.”

To learn more about ISR Reports and the research behind the CRO Leadership Awards, please visit ISRreports.com.

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 Collins, Marketing Specialist

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

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PSI CRO Announces Launch Of VISIONAL™ Study Modeling Tool

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

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

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.

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PSI Named a 2022 CRO Leadership Award Champion in Three Categories

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

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A Letter from PSI CRO AG to Teams Globally

Dear all,

For several days now, full-scale military aggression against Ukraine has been unfolding. There is no rhyme or reason for it, no excuse, no justification, no exoneration.

Our friends, colleagues and teammates are in bad trouble, and we are worried sick about their wellbeing. The country is under martial law.  Business operations are disrupted.

Let us now make a few specific points:

  • As of this writing, all our employees in Ukraine are accounted for and physically safe.  Emotionally, people are understandably distressed, but many have shown remarkable resilience and bravery in the face of hostilities playing out on their doorsteps.
  • Our office in Kyiv is now being used as a living quarters for those employees whose apartments are too close to the frontlines. Also, we’re lucky to have an underground garage that can be used as a shelter.
  • The leadership team in Ukraine are showing incredible resilience. Several times a night, they are awoken by the sound of air-raid sirens and they still make themselves available since the early hours of the morning, supporting their teams, alleviating other peoples’ anxiety and making sound tactical decisions. 
  • An task force consisting of the Country Managers of some of the neighboring countries (Hungary, Romania, Poland) have been working on several scenarios for resettling our employees and their families, if they need to leave the country. It looks like Poland will have to do most of the heavy lifting, for which we should be immensely grateful.
  • So far, the Internet and cellular services haven’t been disrupted, so communication hasn’t been compromised. We’re exploring various backup scenarios in case the situation deteriorates.
  • PSI drug supplies warehoused in the region are intact.
  • For obvious reasons, our ability to maintain normal operations in Ukraine is severely reduced, but, importantly, not paralyzed. Onsite monitoring is currently not possible, but our people still attend calls, file documents, write reports, stay in touch with sites and, amazingly, follow up on the status of patients whenever possible.   
  • Needless to say, the company is providing and will continue to provide support to our staff – financial, logistical, psychological. We only wish we could do more.

Many of our team members have been asking themselves, “What can I do to help?” People have offered to donate their salaries, collect warm clothes for their Ukrainian colleagues, and many other noble initiatives. This is very sweet but unnecessary. Whatever money can buy, the company will take care of that. You can do so much more. Since our operations in Ukraine have been impeded, we need to pick up the slack elsewhere. We know that work is already being redistributed within and among project teams, but we want to drive this message home:  if we all do a little more, we can reduce or even cancel out the damage. Every patient we cannot enroll in Ukraine now will have to be enrolled someplace else; every draft visit report that your teammate in Ukraine cannot review will have to be reviewed by someone else; every document that cannot be timely filed by someone in Ukraine will have to be filed by a teammate elsewhere. Every extra mile, meter, foot, inch, centimeter – counts. No extra effort is too small.

Lastly, for the sake of our collective sanity, let me offer a word of caution:  whatever you hear or read on the news or social media, do take it with a grain of salt. Every kernel of accurate information is heavily intermixed with hearsay, unsupported opinions of pseudo-experts, propaganda and deliberate fabrications.  Information can be and is weaponized – it’s the reality of contemporary warfare. Apply critical thinking – you’re good at this.

Thank you all,

PSI CRO AG

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