Paul Mirek

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

 

 

 

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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 »

Caring doctor and patient

What to Know About Brazil’s New Clinical Research Law

On May 28, 2024, Brazilian President Luiz Inácio Lula da Silva approved new Law No. 14.874, containing new rules for human research. This milestone is the culmination of nearly a decade of negotiations since the original bill, PLS 200/2015, was presented in April 2015.

The new legislation, which takes effect on August 26, 2024, is set to provide a significant boost to sponsors conducting clinical trials in Brazil, offering enhanced security and certainty. Here’s a comprehensive look at the key aspects of this legislation.

  1. A streamlined review process: In the past, Brazil’s approval process was complex, often requiring double approvals by both local ECs and a federal review board, the National Research Ethics Commission (CONEP). The new law simplifies this process by stipulating that ethical analysis be conducted in a single instance by the EC, thereby reducing the number of review steps.
  2. More predictability for startup timelines: The legislation establishes new mandatory timelines for review by Ethics Committees and the National Health Surveillance Agency (Anvisa). Ethical review cannot exceed 30 business days from the date of acceptance of all research documents. If the EC requires additional information or documents from the sponsor, this deadline can be suspended for a maximum of 20 business days. Anvisa’s analysis of primary petitions for trials with human beings is not to exceed 90 business days, except in the cases of certain complex products such as those involving cell or gene therapies. In the latter case, the deadline for review is 120 business days.
  3. Revisions to the mandatory post-trial access requirement: The law provides greater clarity on conditions for access to the investigational drug post-trial, and when needed, provision will not be required after the product is made available by the National Health System.

With the approval of this new legislation, clinical development activity in Brazil is likely to increase, providing greater access to trials for patients within the country and accelerating the availability of new treatments.

PSI CRO has a long history of conducting trials in Brazil, including administering the country’s first gene therapy. Due to our site relationships, our startup timelines for many countries in Latin America are already comparable to those in Europe. To learn more about Law No. 14.874 and whether Brazil makes sense for your pivotal trial, contact us today.

Reviewed by:

Oscar Podesta, Head of Latin America, Country Management

Julia Begalli, Head, Regulatory Affairs, Latin America

Livia Constantini, Regional Project Lead, Latin America

What to Know About Brazil’s New Clinical Research Law 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 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 »

downtown chicago at night over the river

DDW 2023: PSI Team Spotlight

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

Alex Gilfanov
Project Director, Project Management

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

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

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

Heather Thompson
Site Support Specialist

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

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

Meet us at DDW 2023

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

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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 »

PSI Publishes New Report on the Future of Oncology Clinical Research

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

Preparing for the Future of Oncology Clinical Research cover

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

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

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

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

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

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

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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

PSI CRO Announces Launch Of VISIONAL™ Study Modeling Tool Read More »

How to Boost Patient Enrollment in a Global IBD Trial

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

Details:

Therapeutic Area: IBD

Geography: 40 countries

Sites: 400

Patients: 800 (planned)

Current Status:

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

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

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

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

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

3 Steps to Empower Your Sites

  1. Create a compelling, inclusive campaign to motivate sites

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

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

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

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

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

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

  1. Build on a long-standing partnership

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

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