Press Release Archives

Clarity and PSI Kick Off SAR-bisPSMA Phase III

Leave a Comment / Press Release / By Ashley Stufano

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.”

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

PSI Receives Three More CRO Leadership Awards in 2023

Leave a Comment / Press Release, Video / By Ashley Stufano

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

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.

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

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

Press Release / By

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

Press Release / By

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