Press Release

PSI Bulgaria office

Great Move: PSI CRO Expands to New Offices in Bulgaria

PSI CRO, 25 June 2024 – PSI CRO has moved its base of operations in Bulgaria to a new office in Sofia at 1 Atanas Dukov St. This new location allows PSI to continue expanding its presence in the region, combining local expertise with on-the-ground support for sponsors and sites.

The new office is located in one of Sofia’s most dynamic areas, highlighting the company’s commitment to staying agile and providing the highest level of quality for sponsors at the forefront of clinical research.

The PSI Bulgaria Team celebrated the opening of the new office with a tour and toast, surrounded by PSI colleagues from near and far in a welcoming environment. “The offices, the conference rooms, the collaboration areas, any place in the new office here is calm, beautiful, modern, airy, colorful, green, and cozy,” said Genka Rizova, Country Manager. “And that fills us with even more energy and drive to achieve even better performance across our clinical trials in Bulgaria. Our unchanging goal is predictable, reliable patient enrollment across our pivotal trials. Achieving it is never easy. Having a conveniently styled, beautiful, welcoming office space helps uphold the team’s spirit, collaboration and productivity. We are incredibly proud and excited about this new chapter!”

To learn more about the new Bulgaria office or PSI’s full-service CRO capabilities, connect with us here.

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

 

 

 

Great Move: PSI CRO Expands to New Offices in Bulgaria Read More »

PSI CRO Broadens Global Reach by Further Expanding in Greece

PSI CRO, 11 June 2024 – PSI CRO has moved its base of operations in Greece to new offices in the heart of Athens. Located at Ermou 56, Athens 105 63, this new location expands PSI’s presence in the region while allowing the team to broaden site relationships and local expertise.

PSI opened its first Greek office in 2019 and remains committed to the growth and success of its team in the country. The company is dedicated to offering additional support and patient enrollment benefits with its expanded presence, maintaining its focus on on-time, on-budget and on-quality delivery of global pivotal trials across a variety of therapeutic areas.

We invite you to explore PSI’s unique CRO offering here.

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

PSI CRO Broadens Global Reach by Further Expanding in Greece Read More »

PSI Shanghai Office Expands Global Support for Local Biotech & Pharma

PSI CRO, 28 May 2024 – PSI CRO is investing in its operational capabilities in the Asia-Pacific region with a focus on its Shanghai headquarters located at Units 02 and 06, 10th Floor (actual 9th floor), Ascendas Innovation Place, No. 686 Jiujiang Road, Huangpu District. The global full-service CRO relocated to the premises in 2022 and recently welcomed team members to the office for an official celebration.

PSI’s journey in Shanghai has been one of remarkable growth. From its beginnings in the WeWork Tengfei Building in People Square, PSI has quickly expanded its operations. At the end of 2020, the company moved to the 17th floor of the ZhongHai Building, marking another milestone in its growth trajectory.

PSI’s new office is strategically located in the heart of one of Shanghai’s traditional business districts, offering easy access to the metro station, airports, and high-speed train station. This prime location is a testament to PSI’s ongoing commitment to combining local support with global expertise for sponsors of pivotal Phase 2 and 3 trials.  

“The philosopher Lao Tzu said a journey of a thousand miles begins with a single step,” said Lisa Lu, PSI’s Country Manager, China. “At PSI, we are committed to being a trusted companion for our sponsors throughout the challenges of their clinical development journey. With this new move, we have taken another step forward in supporting the exciting future of biotech in China.”  

To learn more about the new Shanghai office or PSI’s full-service CRO capabilities, connect with us here.

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

PSI Shanghai Office Expands Global Support for Local Biotech & Pharma Read More »

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

PSI Receives Four More CRO Leadership Awards in 2024 Read More »

PSI CRO Continues Asia-Pacific Growth, Expands into New Office in Bangkok 

PSI CRO, 7 May 2024PSI CRO is continuing to expand its clinical research operations in the Asia-Pacific region with the opening of a new office in Bangkok, Thailand, at Park Silom, Unit 1407-1408, 1 Convent Road, Silom Bang Rak. The new Thailand location will add to PSI’s expansion in the region, further supporting the on-time delivery of clinical trials through local relationships and broadened operational capabilities. 

In Asia, PSI is already fully operational with a long-standing presence in South Korea, China, Hong-Kong, Taiwan, Singapore, Australia and New Zealand.  Barrie Koh, PSI Head of Asia Pacific, said, “Operational Expansion to Thailand marks a significant milestone for us, reinforcing our continued growth across Asia Pacific. The strategic location of our new office underscores our commitment to serving our clients with excellence, achieving reliable and predictable patient enrollment across the region. Every Patient Counts has been our mantra across PSI globally; here in Thailand it resonates with a great deal of significance and meaning. We are excited to add another high-enrolling country to PSI’s portfolio.” 

The new office is located in the heart of the Silom Bang Rak business district. It offers outstanding connectivity with its excellent transportation options, ensuring convenient access for employees. Additionally, the office space can accommodate a growing team of both operational and clinical local staff, allowing PSI teams to maintain a strong local presence and relationships with the clinical sites in the region.  

With a uniquely modern look and feel, the atmosphere of PSI’s Bangkok office is a testament to the distinctive dedication and partnership that PSI provides for employees and clinical trial sponsors alike. The team celebrated the official opening on April 4 with a ribbon-cutting ceremony and blessing performed by Buddhist monks. 

“Our team is dedicated to delivering exceptional service and solutions, and we are confident that our presence at Park Silom will enable PSI to better meet the evolving needs of our clients,” says Koh. “We extend our gratitude to our employees, sites, and clients for their continued support!” 

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 

 

PSI CRO Continues Asia-Pacific Growth, Expands into New Office in Bangkok  Read More »

PSI Partners With Medidata to Expand Data-Driven Feasibility Capabilities

PSI CRO, 30 April 2024PSI CRO, a leading full-service, global contract research organization (CRO), today announced a partnership with Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, to expand PSI’s data-driven feasibility solutions for pivotal Phase 2 and 3 trials. PSI’s use of the Medidata AI Intelligent Trials solution builds on a long-standing collaboration between the two companies and will add another data source to VISIONAL™, PSI’s proprietary machine-learning-powered study modeling platform.  

VISIONAL™ helps PSI accurately predict study enrollment timelines, beyond human ability, by using historical clinical trial performance data from both internal and external data sources. The collaboration with Medidata will provide PSI with access to the industry’s largest performance dataset for unmatched site-level granularity.  

“PSI is using Intelligent Trials to gain access to aggregated and anonymized global enrollment data,” says Kasia Moscicka, Head of Feasibility, PSI. “A critical process in powering a successful clinical trial is site selection. With a clearer understanding of previous enrollment performance, spanning the industry, a more comprehensive understanding of a site’s capabilities can be developed. PSI is now able to understand a site’s performance outside of trials powered by our organization, which will aid in more concise profiling and selection.”  

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 Collins, Marketing Specialist 919-972-9572 |ashley.stufanocollins@psi-cro.com 

 

PSI Partners With Medidata to Expand Data-Driven Feasibility Capabilities Read More »

PSI CRO Strengthens Global Presence by Opening New Office in Toronto

PSI CRO, 4 April 2024 – PSI CRO has expanded its full-service clinical research capabilities in Canada with the opening of a new Toronto office. Located at 5353 Dundas Street West, Suite 510, in the Etobicoke area, a west-end district of Toronto, the new location builds on PSI’s long-standing presence in the region while strengthening its site relationships and local expertise.

With a convenient location very close to train and bus stations, Etobicoke offers easy access to Lake Ontario and the Toronto Pearson International Airport. The building is modern, open, and welcoming, conveying PSI’s unique culture of excellence, communication, and a friendly atmosphere where colleagues can collaborate effectively.

At the office’s grand opening, the team celebrated with a toast and opening presentations by Doreen D’Souza, Canada Country Manager, and Tibor Kovacs, Head of Operations, North America, to highlight local expertise in the industry.

Doreen D’Souza said of the day’s event, “Canada has a strong history in clinical research with an equally strong ecosystem, world-renowned key opinion leaders, and diverse population for conducting clinical trials, so it is wonderful to see a growing PSI presence in Canada.”

To learn more about the new Toronto office or PSI’s full-service CRO capabilities, connect with us here.

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

PSI CRO Strengthens Global Presence by Opening New Office in Toronto Read More »

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

Clarity and PSI Kick Off SAR-bisPSMA Phase III Read More »

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

PSI Receives Three More CRO Leadership Awards in 2023  Read More »

PSI CRO Expands Operations in France With New Paris Location 

PSI CRO, 22 February 2023 – PSI CRO has relocated its office in Paris, France to a new space at 50 Boulevard Rabelais, CS 50021, 94106 Saint-Maur-des-Fosses, Cedex. This is the second time PSI has expanded its operations in France in the past four years, having moved to its previous Paris location in September 2019.

PSI is the sole occupant of the new three-story building located in the center of Saint-Maur-des-Fosses, a commune in Val-de-Marne, the southeastern suburbs of Paris, in the region of Île-de-France. Located near the train station and a bustling downtown hub, the new space positions PSI to continue broadening its operational capabilities and site relationships to support sponsors of pivotal trials.

To celebrate the space’s opening, PSI hosted an open house event to welcome in-area representatives from the community. The inauguration included a red ribbon ceremony, champagne, a buffet, and an official guided tour of the office.

To learn more about the new Paris office or PSI’s full-service CRO capabilities, connect with us here.

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

PSI CRO Expands Operations in France With New Paris Location  Read More »