Press Release Archives

PSI CRO Announces Launch Of VISIONAL™ Study Modeling Tool

Leave a Comment / Press Release / By Paul Mirek

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

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

PSI Named a 2022 CRO Leadership Award Champion in Three Categories

Leave a Comment / News article, Press Release / By Paul Mirek

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

In 2021, PSI Earns Five More CRO Leadership Awards and a Champion Award

Press Release / By Brian Barrier

PSI CRO, 03 MAY 2021 – PSI CRO has again received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Science Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations. In addition to the five leadership awards, PSI CRO has been named as a Champion in the category of Expertise in 2021.

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For the 2021 selection round, 60 CROs were evaluated on more than 20 performance metrics in the annual Benchmarking Survey.

“Industry Standard Research continues to consider it an honor to provide the primary market research data for Life Science Leader and Clinical Leader’s CRO Leadership Awards. 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.”

In 2020, PSI CRO received leadership awards in the same five categories across both respective respondent groups. The 2020 award repeated the awards earned in 2019, which were a level above the 2018 award. In 2021, the addition of the Champion Award is a new recognition of our dedication to expertise. “Yet again, the tireless work of our teams around the world won the hearts and minds of our customers who gave us this resounding vote of confidence. Being recognized as a Champion in Expertise, in addition to receiving the Leadership Awards, is both gratifying and exciting; it is also a lot to live up to,” says PSI’s President, Nick Sinackevich. “We now have a new benchmark to improve upon.”

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 is known to be highly selective about the work that they pursue. 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 customers and its employees.

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

For Media Inquiries:
Kayt Leonard, Public Relations Manager
919-972-9572 | Kayt.Leonard@psi-cro.com

PSI CRO Continues Growth, Expands into New Office in Israel

Leave a Comment / Press Release / By Brian Barrier

PSI CRO, 08 March 2021: PSI CRO has announced opening a new office in Ra’anana, Israel, at 2 HaNufar Street, 10^th floor. The office relocation allows PSI to continue to expand its growing team in the region, and further support the on-time delivery of clinical trials.

In light of the Coronavirus pandemic, moving during this time had added difficulties. However, it also had added benefits. “As part of the move to the new office and the desire to maintain the health of employees, we decided to examine a number of systems for improving and purifying the air,” states Ronit Pakula, Country Manager of Israel. “While we have worked remotely through much of the pandemic, companies in Israel are returning to in-person workplaces. Employee safety is and has always been a top priority for PSI, no matter what.”

With health and safety as the top priority, PSI Israel added the Electra UV light purification system to its air conditioning systems. The system has shown remarkable success in air purification to help fight and eliminate harmful bacteria and viruses, such as COVID-19. When considering what extra safety option PSI could take, Ronit noted, “After a comprehensive examination of the alternatives presented to us, I was convinced that Electra’s solution with the UV bulb, developed and manufactured in Israel, is the option that provides the best solution for air purification throughout the office. The system integrates naturally into the existing air conditioning system.”

About Electra UV: Electra presents the most advanced and safe air purification technology in the world. UV technology has been a proven technology for many years in water purification, operating rooms, food packaging, air conditioning and more. The use of a UV lamp harms viruses, bacteria, germs and microorganisms and neutralizes their reproductive capacity.

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 is known to be highly selective about the work that they pursue. 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 customers and its employees.

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

For Media Inquiries:
Kayt Leonard, Public Relations Manager
919-972-9572| Kayt.Leonard@psi-cro.com

PSI CRO selected by POINT as preferred partner to lead clinical trial program

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POINT Biopharma Announces Phase 3 Prostate Cancer Trial, Selects PSI as Preferred Partner to lead Clinical Trial Program

TORONTO, May 12, 2020: POINT Biopharma Inc. is pleased to announce the selection of PSI CRO to manage its phase 3 clinical study of PNT2002, a ¹⁷⁷Lu-PSMA radiotherapeutic for the treatment of metastatic castrate-resistant prostate cancer.

“PSI CRO is a leading, full-service, global clinical research organization, and is excited to be selected as the preferred provider to POINT to lead this important study,” says Tibor Kovacs, Head of North American Operations, PSI CRO.

POINT Biopharma is working to revolutionize radiopharmaceutical drug development and commercialization. “Choosing the right CRO partner is crucial to the success of any trial, but even more so in nuclear medicine studies,” stated POINT Biopharma’s Chief Commercial Officer, Michael Gottlieb. “PSI CRO has a proven track record of delivering radiopharmaceutical studies on time and on budget, and that means getting our product to market quickly and introducing new competitive oncology therapies to the Novartis radioligand portfolio.”

“POINT is excited to partner with PSI CRO and launch a phase 3 registration trial of PNT2002 in prostate cancer patients,” says Joe McCann, CEO of POINT Biopharma. “This ground-breaking trial design will offer physicians and patients new options. Enrollment is expected in the fourth quarter of 2020.”

About PSI CRO: PSI CRO is a privately-owned, full-service clinical research organization operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and is known to be highly selective about the work that they pursue. 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 customers and its employees.

About POINT Biopharma: POINT Biopharma is a globally focused radiopharmaceutical company with a growing portfolio of best in class pharmaceutical assets. POINT is combining a seasoned management team with strategic partnerships in radio-isotope supply, manufacturing technology and novel direct to patient targeting to revolutionize theranostic drug development and radioligand commercialization. Working closely with its scientific advisors, the Company anticipates commencement of its clinical trial programs in 2020.

For POINT Biopharma Investor or Media Inquiries:

Michael Gottlieb, CPA

647-268-4160 | Michael.Gottlieb@pointbiopharma.com

For Media Inquiries:

Kayt Leonard, Public Relations Manager

919-972-9572| Kayt.Leonard@psi-cro.com

In 2020, PSI Earns Five More CRO Leadership Awards

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After Receiving Honors in 2018 and 2019, PSI Continues Top Performance

PSI CRO, 01 May 2020 – PSI CRO has again received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Sciences Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For the 2020 selection round, 60 CROs were evaluated on more than 20 performance metrics.

“When talking to clinical operations executives, I’m told the CRO selection process can be one of their most stressful and time-consuming chores,” says Ed Miseta, Chief Editor, Clinical Leader. “Anything we can do to help steer our readers to those partners that best meet their needs can significantly reduce the burden of their search. That is why we are once again proud to partner with Industry Standard Research to produce our annual CRO Leadership Awards. We applaud these companies for their hard work in meeting the needs and expectations of their pharma and biotech clients.”

In 2019, PSI CRO received leadership awards in the same five categories across both respective respondent groups. The 2019 awards raised the bar from the four awards that were received in 2018 across the same respondent groups. “A sincere and heartfelt thank-you goes to our loyal customers who have continued to cast their vote in our favor and partner with us, and, even more so, to the PSI employees who continue to ‘wow’ customers year over year,” says PSI’s President, Nick Sinackevich.

For Media Inquires:

Kayt Leonard, Public Relations Manager

919-972-9572| Kayt.Leonard@psi-cro.com

PSI CRO Opens New Office in RTP, Continues Record Expansion

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PSI CRO, Durham, NC, 12 December 2019 – PSI CRO has officially opened its new office space in Research Triangle Park, located at 10 Laboratory Drive. This news comes after the earlier announcement that PSI CRO purchased the property at the end of 2017.

The newest space in RTP is a testament to the continued growth of the company, which caused PSI CRO to expand operations faster than originally anticipated when they launched in North Carolina three years ago. “We outgrew our projections and opened our interim space at Laboratory Drive in Q2 of 2018. For the following year, we worked across two locations until our main building on the property was completed,” says Director of North Carolina Operations, Sabine Kroher-Debuschewitz. “With the opening of our completed space, we’re able to accommodate a rapidly growing team in a region stocked with great biotech and pharmaceutical partners.”

The RTP office is just one of many that PSI CRO has opened in 2019. Since January, new locations have opened in Paris, Sydney, Tbilisi, and Shanghai.

To celebrate the opening of the RTP space, PSI CRO hosted an open house event on November 12^th to welcome in area representatives from the local RTP community. During the opening, Rhonda Critchlow, Senior Director Operations at PSI CRO, presented on Basket Studies and shared PSI’s expertise in running basket, platform, and umbrella trials globally.

“We’re fighting each day to bring drugs to market that are saving lives, and the basket trial and adaptive study approach is a must,” says Critchlow.

To learn more about the new office in RTP, and to learn more about PSI’s full-service CRO capabilities, connect with us here.

About PSI CRO: PSI 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 is known to be highly selective about the work that they pursue. 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 customers and its employees.

For Media Inquiries, Contact:

Kayt Leonard, Public Relations Manager

Kayt.Leonard@psi-cro.com

PSI Earns Five CRO Leadership Awards

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PSI CRO, ZUG, SWITZERLAND, 15 March 2019 – PSI CRO has received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Sciences Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI’s President Nick Sinackevich said, “Receiving the CRO Leadership Award for the second year in a row is immensely gratifying. Collecting top rankings in as many as five categories — compatibility, expertise, quality, reliability, and capabilities – makes it sweeter still. A heartfelt thank-you goes to those loyal customers who have cast their vote in our favor and, even more so, to the PSI employees who wowed the customers with their superb effort and commitment in the first place.”

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For this round, 60 CROs were evaluated on more than 20 performance metrics. “We believe the CROs receiving an award this year are truly at the top of their class and are deserving of this recognition. Being a top performer in any of these categories shows a level of expertise and commitment to clinical trials and serving the needs of biopharmaceutical companies and their patients.” Ed Miseta, Executive Editor, Life Science Leader.

Additionally, PSI placed in attribute awards for Data Quality, Meeting Overall Project Timelines, Technology for Access to Data, Operational Excellence, and Responsiveness.

In 2018, PSI received four CRO Leadership Awards across Compatibility, Expertise, Quality, and Reliability. The bar was raised high, and it is exciting that the company continues to grow and excel in every aspect of its operational performance.

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 is known to be highly selective about the work that they pursue. 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 customers and its employees.

For Media Inquires:

Kayt Leonard, Public Relations Manager

919-249-2671 | Kayt.Leonard@psi-cro.com

Organizations Raise Awareness of Blood Cancer at ASH, Announce 2019 Innovation Teamwork

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Organizations Raise Awareness of Blood Cancer at ASH, Announce 2019 Innovation Teamwork

Durham, North Carolina, 30 November 2018 PSI CRO and Gift of Life Marrow Registry are teaming up to recruit ASH attendees to join the bone marrow registry this year during the American Society of Hematology (ASH) Annual Meeting in San Diego, California. In addition, PSI CRO is also announcing the support of the Gift of Life Apheresis Center launching in 2019.

The ASH Annual Meeting hosts more than 25,000 hematology professionals in San Diego during a four-day conference. PSI CRO is excited to partner with the Gift of Life Marrow Registry at ASH 2018 to bring awareness to blood cancer and the life-saving possibilities of the marrow registry.

At the conference, PSI CRO will announce and share details of their partnership with Gift of Life to support their Apheresis Center launching in 2019. The in-house Apheresis Center is the first of its kind, and will support donors in South Florida and surrounding areas to make stem cell collections more convenient, comfortable, and available to all.

Gift of Life Marrow Registry specializes in engaging the public to build and increase the marrow registry to end blood-related cancers and diseases. “At PSI, we’re proud to support Gift of Life. Our long-standing experience in hematology clinical trials means we have a deep understanding of the patients’ experience,” said PSI CRO Senior Director of Operations Rhonda Critchlow. “Supporting an organization dedicated to finding an end for blood cancer is close to our hearts.”

“PSI CRO has been an enthusiastic partner in our mission to save lives, inviting their own employees to join the registry for the opportunity to save a patient’s life,” said Gift of Life Marrow Registry CEO and Founder Jay Feinberg. “They are taking that commitment even further by supporting our new Stem Cell Collection (Apheresis) Center. We will open our registry-integrated state-of-the-art collection center in April 2019, which will improve efficiency, streamline operations and increase service level to patients, transplants centers and donors.”

To learn more about Gift of Life, join PSI CRO at ASH booth 118 or visit the website at www.giftoflife.org. To learn more about the teamwork between PSI CRO and Gift of Life, visit the newsroom at www.psi-cro.com/newsroom.

About Gift of Life Marrow Registry:

Gift of Life Marrow Registry is a 501(c)(3) non-profit organization headquartered in Boca Raton, Fla. Gift of Life is dedicated to saving lives and facilitating bone marrow and blood stem cell transplants for patients with leukemia, lymphoma and other blood-related diseases. For more information, visit www.giftoflife.org.

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 is known to be highly selective about the work that they pursue. 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 customers and its employees.

Teaming Up: Headbands of Hope, North Carolina Children’s Hospital and PSI CRO

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PSI CRO, Durham, NC, 29 October 2018 PSI CRO is partnering with Headbands of Hope to donate more than 200 headbands to children at North Carolina Children’s Hospital, one of the world’s leading children’s hospitals.

“We are very excited about this donation with Headbands of Hope,” says Sabine Kroher-Debuschewitz, PSI Director of Operations in North Carolina. “Headbands of Hope has made an incredible impact in the lives of so many children battling cancer, and their focus is close to our hearts at PSI. As a team, we’re thankful to have the opportunity to give back to the communities that we’re dedicated to.”

Headbands of Hope has donated headbands to every children’s hospital in America and in 13 different countries. Together, PSI and Headbands of Hope are hosting the donation event at North Carolina Children’s Hospital on October 30^th. In addition to this event, the two organizations will coordinate donations in both San Francisco and Philadelphia at later dates. These locations are chosen based off of proximity to additional PSI offices in the US.

About Headbands of Hope: Headbands of Hope LLC is an organization founded by Jessica Ekstrom who wanted to make a difference in the lives of children battling cancer. For every item sold, a headband is donated to a child battling cancer. Since launching in 2012, Headbands of Hope has donated over 285,000 headbands to every hospital across the United States and in thirteen countries. Headbands of Hope is carried in thousands of stores across the world. They’ve been featured on the TODAY Show, Good Morning America, Vanity Fair, Seventeen Magazine, and even supported by celebrities like Lea Michele, Lauren Conrad, Kelsea Ballerini, Lili Reinhart and more.

About PSI CRO: PSI 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 is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is on a mission to be the best CRO in the world as measured by its employees, customers, study sites, and vendors.