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PSI Receives Four More CRO Leadership Awards in 2024

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

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

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

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

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

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

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

About PSI: PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and specializes in the planning and execution of global pivotal registration clinical trials. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors.

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

For Media Inquiries:

Ashley Collins, Marketing Specialist

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

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

woman with cancer looking at the viewer

Enrolling a Rare Ovarian Cancer Trial 2 Years Ahead of Schedule

At a Glance

The sponsor of a Phase 2 trial in rare ovarian tumors knew enrolling on time with an exceedingly small patient population and a wide global spread would be challenging. PSI worked with the sponsor and leveraged our strong site relationships around the globe, to not only meet but exceed enrollment goals. Ultimately, we supported the sponsor by completing enrollment in nine months, more than two years ahead of schedule, and enrolling ten more patients than initially planned.

enrollment graph with red and blue lines

Phase 2 Rare Ovarian Cancer Study

Sponsor Challenges

As with many rare disease trials, one of the greatest challenges was that there had never been a study that enrolled this specific population, and epidemiology data was likewise scarce. There is also a high administrative burden for rare disease trials that are slow to enroll; locating enthusiastic investigators who will stay motivated throughout the trial is vitally important.

PSI Strategy

1) Finding the right sites and patients

PSI turned to our network of more than 4,000 oncology sites, and positive working relationships with investigators active in gynecological cancer research around the world. This allowed us to identify the ideal sites with a high volume of ovarian cancer patients and key opinion leaders specializing in rare ovarian tumors. Many of these centers met our ideal site profile, as the sites are large institutions that see a high flow of ovarian cancer patients. The data from other countries was perfectly acceptable.

2) The value of site relationships

Because our CRAs understand each site’s organizational structure and can anticipate their needs, PSI was able to provide tailored site support to ensure consistent enrollment. In order to screen and enroll every patient possible, our team worked with the investigators to track and monitor patients with eligible criteria, so that upon relapse, patients could be screened for potential entry into the study.

3) Every patient counts

Enrollment was often a literal race against time. A last-minute eligible patient was scheduled to travel to a site to enroll in the study, but the IRB (Institutional Review Board) required additional changes to the ICF (Informed Consent Form) for this particular study the day before the patient’s arrival. The team was able to get the consent language finalized and resubmitted the same day. The approval came in the day of the patient’s arrival, and PSI worked simultaneously with the sponsor to get the IP-RED approved in time.

Results

  • 25% more patients enrolled than targeted
  • LPI achieved in 9 months
  • Enrollment completed 2 years ahead of schedule

Learn how PSI can support your oncology study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Oncology Experience

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, and other Oncology indications. 93 percent of PSI’s oncology studies meet or beat projected enrollment timelines.

The Future of Oncology Clinical Research

This white paper provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Enrolling a Rare Ovarian Cancer Trial 2 Years Ahead of Schedule Read More »

nurse holding the hand of an older man

Winning the Biosimilar Race: Trastuzumab Biosimilar Phase III Breast Cancer Study

At a Glance

A sponsor of a global Phase 3 study of a trastuzumab biosimilar came to PSI after falling behind schedule with their current CRO. Drawing on PSI’s biosimilar experience going back to the first such product ever approved by the FDA, we supported the sponsor in recruiting the required 800 patients in just over a year, leading to an EMA approval. Before getting there, though, we had to navigate additional challenges, including an unexpected delay that led to late site activation – just before the summer slow-down.

Phase 3 study in a Trastuzumab biosimilar

Sponsor Challenges

Speed and cost are key for biosimilar development, but development is not necessarily less complex than for a reference biologic. It requires state-of-the-art manufacturing expertise to ensure the biosimilar is “highly similar” with no significant clinical differences in safety profile, efficacy, and potency. Competition for patients against other studies with novel therapeutics often amplifies these challenges.

For PSI’s transition of a global Phase 3 study of a trastuzumab biosimilar in HER2+ early breast cancer patients, it was critical to understand the patient flow from surgery to chemotherapy and back. An additional challenge was that the sponsor’s previous CRO had placed the study primarily in Western countries, where higher standards of care and availability of trastuzumab are common.

How our team made a difference

1) Understanding the landscape

PSI started by thoroughly assessing the country landscape and the product’s reception by sites from our vast oncology network. We selected 100 sites in 10 countries in Eastern Europe, Asia-Pacific, Latin America, and South Africa. The US was also included due to prior expectations from the FDA. The data from other countries was perfectly acceptable.

2) Ready for the green light

Our startup roadmap had to be adjusted when the sponsor put the study on hold for internal reasons, leading to almost half a year of delay in site activation. While waiting for the go-ahead to resume activation, the PSI team prepared contracts ahead of time and had vendors and sites in standby mode. The preparation paid off: as soon as PSI was notified, our teams activated the remaining sites almost simultaneously.

3) Relentless focus on patient enrollment

Because of the delay, site activation occurred just before the summer break, leading to a slow start to patient enrollment. PSI and the sponsor decided to implement several enrollment-boosting measures and organized local investigator meetings for open discussion. A common concern we heard from sites was time and resources, so we optimized site processes to make their work more efficient and focused on the personal relationships of our CRAs and Medical Monitors with investigators and site staff. By optimizing our SDV strategy, close cost control, and the implementation of a blinding system that allowed us to perform drug accountability without the need for a whole unblinded team, we obtained important cost efficiencies.

Program Successes and Outcomes

  • 800 patients enrolled in just over a year
  • Last patient enrolled only 2 months later than initial goal, despite 6-month startup delay
  • Successful FDA inspection and EMA approval

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Oncology Experience

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, and other Oncology indications. 93 percent of PSI’s oncology studies meet or beat projected enrollment timelines.

The Future of Oncology Clinical Research

This white paper provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Winning the Biosimilar Race: Trastuzumab Biosimilar Phase III Breast Cancer Study Read More »

Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study

At a Glance

Antibiotic development is notoriously underfunded, so running a pivotal phase 3 study can be a challenge. From the beginning, PSI supported the sponsor by leveraging our global site relationships and experience with pivotal antibiotic trials for the most pragmatic site selection. This helped us enroll the trial at a rate 23% higher than industry metrics in the same indication, with Last Patient In (LPI) occurring during the peak of the first COVID-19 wave. It wouldn’t have been possible without our investment in building close site relationships – because our CRAs act as site ambassadors, sites want to work with PSI and prioritize our studies, even in the midst of a pandemic. 

Antibiotic CS enrollment

Phase 3 study in cUTI - Enrolled 23% above industry metrics in the same indication

Sponsor Challenges

Where did anyone see an easy Phase 3 trial lately: timelines slip, vendors get acquired, standards of care change, interest dwindles, competition doesn’t stand still…the list goes on and on.  These studies are meticulous and require a great amount of time and attention.  With a study of this magnitude, ensuring the quality of data globally was also critical.

PSI Strategy

1) Antibiotic Experience

PSI’s strategy for delivering these studies has been tried and tested, ensuring our sponsors the most effective way to deliver antibiotics to market. We also have experience working with BARDA, so we were able to manage the complexities of working with them on this study.

2) The Right Team

PSI invests time and resources to build close site relationships; we empower our CRAs to go further than is typical across the industry. This means sites want to work with PSI, they prioritize our studies, and we understand their preferred methods of working and individual quirks.  

3) Commitment to Quality

The team understood that delivering the data on time was crucial for the study’s success. PSI used a network of regional microbiology labs to ensure the quality of data globally. Despite COVID-19 lockdowns and limited access to sites and patients, our CRAs were able to work closely with site staff to understand each sites individual needs and processes and ensure that all necessary data was collected and cleaned in time to meet key trial milestones.

Results

  • Enrollment rate 23% higher than industry metrics in the same indication 
  • More than 95% of sites enrolling patients 
  • Enrollment of 1,370 patients delivered in 11 months  
  • Screen failure rate of only 5% 

Learn how PSI can support your antibiotic or infectious disease study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Infectious Disease Experience

We are an antibiotic powerhouse. 8 out of 12 novel antibiotics approved by the FDA since 2010 used pivotal clinical data generated by PSI sites.

White Paper

Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial? Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints 

Overcoming Global Challenges and Meeting Enrollment on a Phase III cUTI Antibiotic Study Read More »

nurse holding the hand of an older man

Fast Start-Up & Beating Enrollment Milestones on a Phase II UC Study

At a Glance

When a small biotech approached PSI to run a complex UC study, the sponsor’s concerns were clear: streamline initial set-up, avoid complex vendor management, and overcome multiple operational challenges. PSI was up to the challenge, helping the sponsor achieve 50% enrollment five weeks before their goal and complete enrollment more than five months ahead of schedule.

Phase 2 study in UC - Achieved 50% enrollment five weeks before their goal

Sponsor Challenges

Clinical trials are inherently uncertain, and this study highlighted the inevitability of unforeseen challenges more than most. Along with the impact of the COVID-19 pandemic, this sponsor encountered challenges such as poor performance of a central lab, issues with their IP supplies vendor, medical staff turnover, site activation delays due to equipment set-up, and the greatest challenge of all, a major study redesign and update post startup following FDA feedback.

PSI Strategy

1) Identifying the Perfect Geomix and Ensuring Fast Startup

To ensure fast site startup in the US, PSI identified the central IRB sites with both the right experience and the shortest contract finalization timelines from our database of more than 4,000 global sites. Our Site Qualification Specialists also confirmed sites were properly equipped to use study equipment before the Site Initiation Visit to avoid slowdown during activation. Using VISIONAL™, PSI’s proprietary data-driven feasibility and enrollment forecasting tool, the team identified the best country mix and site profile by collating historical enrollment rates in the given patient population from both internal and external data sources.

2) Invested in Communication

Communication with sites was crucial to enroll patients ahead of schedule. The Study Coordinator organized meetings with each site to discuss the study and each site’s immediate next steps. During the startup process, our CRAs began in-depth training and coaching with all relevant site staff on topics such as best practices for patient consent conversations, raising site awareness, study-specific tasks, and developing a site-specific patient flow to understand the referral process. PSI also developed site-facing enrollment boosting materials and contacted sites weekly to maintain investigator motivation, track screening and enrollment, and investigate any challenges with low enrollment.

3) Next-Level Site Support

Dedicated to building site relationships and understanding the dynamics of each site at the local level, PSI’s Site Support Specialists ensured that each site was supported and had the resources necessary to enroll patients effectively and maximize protocol compliance. The team developed and maintained communication pathways between the combination of physicians/departments, lab specialists, and nurses to facilitate the smooth flow of referrals, and utilized a suite of proprietary PSI tools to ensure sites understood individual stakeholder responsibilities and key study strategies.

Results

With the help of our CRAs, site support specialists, and other team members, PSI closed screening due to high volume even while sites had additional patients. We achieved 50% of the enrollment goal five weeks before the sponsor’s goal and completed enrollment more than five months ahead of schedule. The team also worked closely with investigators to ensure activation timelines were met, helping us achieve the first site activation in just 3.5 months.

“You have met and exceeded my hopes and expectations. I have seen so many challenges, and together we work through them. Speaking for myself and the entire team, we are grateful for this partnership and proud of what we have all accomplished together.”

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

GI Experience

As the need for clinical trials in Crohn’s disease and ulcerative colitis grows, partnering with the right CRO matters more than ever. 100% of PSI’s GI and IBD studies have enrolled on time or ahead of schedule.

White Paper

Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial? Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints 

Fast Start-Up & Beating Enrollment Milestones on a Phase II UC Study Read More »

Case Study: Achieving Success in the Largest-Ever Study of a Hemophilia Gene Therapy

At a Glance: Managing a 9-study, 21-year program with over 1,240 patients enrolled

PSI supported the sponsor of a program of studies that allowed hemophilia patients access to a gene therapy product for the first time, including the first gene therapy product to be administered in Brazil. By working closely with sites, building trust, and mitigating staff turnover, PSI was able to achieve FDA and EMA approval for nine studies over the course of a 20+ year program, including the largest-ever study of a hemophilia gene therapy.

HemophiliaCSgraph

Phase 3 study in severe hemophilia A

Sponsor Challenges

The first of its kind to offer gene therapy options to hemophilia patients, this extensive nine-study program required stellar teamwork to mitigate challenges from the outset, including high competition for patients, an intensive patient visit schedule, and complex dosing requirements and lab management. Maintaining consistency in trial oversight over the course of two decades to ensure the highest level of management and governance was crucial for the success of such a trial.

PSI Strategy

  • Strong site relationships: PSI has been building hemophilia site relationships for over 20 years. PSI knows the investigators and invests time and resources to build close site relationships, so sites want to work with us and prioritize our studies.
  • Building trust: From the outset, we worked closely with sites, where possible selecting sites that delivered for us on other studies. Additionally, the team implemented meticulous visit planning and site support, using both the Investigator Meeting and co-monitoring visits to build motivation for investigators and help the client gain valuable insights during the program.
  • Low staff turnover rate: PSI enjoys a low turnover rate – just 15% for the key staff on this portfolio. As we retained our staff, there was significant overlap across the portfolio teams, keeping valuable knowledge of the IMP and maintaining site relationships to deliver recruitment that exceeded the global average.

Program Successes and Outcomes

  • 7 successful FDA Inspections
  • EMA and FDA approvals granted
  • Same Project Manager/Project Director for 5 years
  • Creation of client-specific data and budget tracking system
  • 10+ long-term follow-up studies awarded to PSI based on performance

Learn how PSI can support your hemophilia study at the resources below or contact us today

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Hematology Experience

Multiple Myeloma, Lymphomas, Leukemias, and other oncohematological indications. More than 50% of operational staff has hematology and/or oncohematology experience.

Demystifying Biosimilar Development Regulations

Meet our team of experts at this year’s conference where we will be exhibiting at our booth #3352. 

Case Study: Achieving Success in the Largest-Ever Study of a Hemophilia Gene Therapy Read More »