Ashley Stufano

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 »

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 »

outlines of people in blue paint with a magnifying glass over one of them

Using Data & Safety Monitoring Boards: From Planning to Execution

Is a DSMB right for your study?

The randomized clinical trial (RCT) is the gold standard for evaluating the benefits and harms of new medical interventions. Safety surveillance is one of the core objectives of every RCT, and one such body is a Data and Safety Monitoring Board (DSMB) – also known as a Data Monitoring Committee (DMC). 

A DSMB is an independent group of individuals with relevant expertise external to the study sponsor, charged with a periodic review of clinical trial conduct, efficacy, and participant safety and recommending trial continuation, changes, or termination when appropriate. However, the role of DSMBs has evolved since their initial creation, making their management more challenging and complicated. 

Read our new white paper to learn about: 

  • How the role of the DSMB has evolved in recent years and current challenges in DSMB management 
  • When a DSMB is needed  
  • The primary considerations for committees to maintain eligibility, credibility, and high-quality outcomes 

About Us

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

Case Study

Antibiotic development is notoriously underfunded, but PSI meets enrollment rates 23% higher than the industry average. See how PSI supported this sponsor by leveraging site relationships for the most pragmatic site selection.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Using Data & Safety Monitoring Boards: From Planning to Execution Read More »

marks in sand around rocks

Putting the Focus Back on Site Relationships Part 3: The Patient Journey

This is the third in a series of posts based on PSI’s new white paper, Putting the Focus Back on Site Relationships in Clinical Trials. Part 1 focused on the common challenges sites encounter while running clinical trials, while Part 2 discussed strategies to help ease the burden of sites, which ultimately supports sponsors in meeting trial timelines and milestones. In this final post in the series, we’ll explore why considering the patient journey first is an essential – and often overlooked – element of the relationship between CROs, sponsors and sites..

Considering the patient journey

Evaluating study procedures from the perspective of the patient can help minimize patient burden and the overall impact on sites. Providing site training and materials to smooth patient transitions and processes can improve the likelihood of meeting enrollment and retaining patients. These materials offer guidance and reassurance to patients after they leave the site. This makes it easier for sites to develop meaningful and valuable relationships with patients because less time is spent on repetitive tasks such as reviewing basic study information and processes.1

PSI charts out the patient’s journey for each study, allowing site teams to understand the needs of the patient and study requirements more clearly. For example, suppose the patient needs to have a lab specimen taken eight hours after the investigational product administration. In that case, the site team can plan for the patient needs, such as space for the patient or food vouchers. In turn this reduces the potential protocol deviations, ensuring the quality of the study endpoints.

psi patient journey chart

Concluding thoughts: Why site relationships really matter

In addition to boosting engagement, making sites feel heard, and reducing turnover, there are many other benefits to building strong site relationships. As PSI has learned, when we can understand and even predict the needs of each site, we can provide sites with self-awareness about which trial programs are right for them. In turn, this allows us to provide our future sponsors with insight into how to identify the optimal sites for their particular trials, further reducing operational waste.

When it comes down to it, sites want to work with CROs and sponsors with whom they have positive experiences. Making them feel heard, reducing project team turnover, optimizing change management, and providing support are all part of improving site relationships.

If you’re looking to expand the horizon of your next clinical trial, partner with the CRO with global reach, Swiss quality, and on-time delivery. At PSI, we understand your needs and what it takes to help your product achieve global success. Learn more about how PSI prioritizes our sites by downloading the full white paper or get in touch with our team to discuss your feasibility needs.

1WCG CenterWatch. (2023). 2023 WCG CenterWatch Global Site Relationship Benchmark Survey Report for Sponsors. Falls Church, VA. WCG CenterWatch.

About Us

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

Case Study

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.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Putting the Focus Back on Site Relationships Part 3: The Patient Journey 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 »

man sitting behind a pile of paperwork

Putting the Focus Back on Site Relationships Part 2: 3 Strategies for Mitigating Trial Site Burden

This is the second in a series of posts based on PSI’s new white paper, Putting the Focus Back on Site Relationships in Clinical Trials. In Part 1, we discussed three of the most common challenges sites encounter while running clinical trials with sponsors and CROs. A lack of communication, resources, training and support can impact sites’ ability to enroll patients, in addition to complicating the patient journey. In this post, we share three of PSI’s strategies to help ease the burden of sites, which ultimately supports sponsors in meeting trial timelines and milestones.

When aiming to improve site relationships, there is no better place to start seeking feedback than the sites themselves. In a recent survey by WCG CenterWatch,1 the top 10 CRO attributes most valued by sites are:

  • Quality of communication with study team/site staff
  • Responsiveness to site staff inquiries
  • Organization and preparedness
  • Professionalism, knowledge, and training of monitors/CRAs
  • Access to staff for escalation and resolution of issues
  • Professionalism of staff in clinical operations functions
  • Ongoing help/support provided in running the study
  • Ability to effectively work with sponsors
  • Professionalism and efficiency of administrative staff
  • Efficiency in contract and budget negotiation
While the list of attributes has remained largely consistent over the past few years, attributes seven through ten were added this year, reflecting a shift in site priorities when working with CROs toward “overall project support, study monitoring, and contracts and budget handling.”1

Strategies for successful site relationships

When considering how to build strong site relationships, look to the qualities considered most important to sites, yet which received low actual rankings in terms of delivery.

Flexibility and openness when dealing with protocol and budget modifications, practicing open communication, and reducing staff turnover are among the top concerns for sites.2

Prioritizing technology and process integration can ease the technology burden of site staff, keeping training and retraining to a minimum.

A key reason for enrollment slow-down at the site level (as well as overall timeline delays and additional costs for sponsors) is excessive protocol amendments. To help guard against this risk, sponsors should seek to optimize protocols as much as possible during the trial design phase.2

Scientific Advisory Boards are often valuable for assessing patient burden and suggesting improvements to study design and inclusion criteria during early review. Through PSI’s SAB protocol review and recommendations, future protocol amendments are minimized. When protocol and budget amendments occur, there should be thorough guidelines and clear communication of all necessary changes and processes to the site.

The patient journey is another element to consider during trial design and implementation. We’ll dive into this further in our third and final post in this series.

Site support solutions for pivotal Phase 2 and 3 trials

Understanding how to navigate the needs of individual trial sites is crucial for the success of your trial. With a global database of more than 4,000 sites and a unique approach to site support, including our dedicated Site Support Specialists, PSI excels in delivering studies on time and on budget.

Download the full white paper here, or contact us to learn more about running your pivotal Phase 2 and 3 trials with PSI.

1 WCG CenterWatch. (2023). 2023 WCG CenterWatch Global Site Relationship Benchmark Survey Report for Sponsors. Falls Church, VA. WCG CenterWatch. https://www.centerwatch.com/products/587-2023-wcg-centerwatch-global-site-relationship-benchmark-survey-report-for-sponsors#:~:text=The%202023%20Global%20Site%20Relationship,more%20than%203%2C600%20site%20representatives.

2 Malloy, M., & Cammarata, N. (2022, July 18). Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites. Clinical Leader. Retrieved November 21, 2023, from https://www.clinicalleader.com/doc/tips-for-clinical-trial-sponsors-to-cultivate-meaningful-relationships-with-sites-0001

About Us

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

Case Study

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.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Putting the Focus Back on Site Relationships Part 2: 3 Strategies for Mitigating Trial Site Burden Read More »

woman looking into a microscope

Putting the Focus Back on Site Relationships Part 1: Top Site Challenges 

Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints. Yet fostering deep site relationships is often overlooked because many CROs are simply unable or unwilling to put in the effort, resources, and time necessary to do so.   

While historic challenges like staffing shortages, trial complexity, and issues related to site startup have intensified, they are now joined by the need to often learn and implement unfamiliar new technologies with little support and training. Our new white paper, Putting the Focus Back on Site Relationships in Clinical Trials, digs deeper into the evolving challenges sites face as well as PSI’s real-world strategies for supporting our site partners – and our sponsors in turn. 

3 Top Challenges for Sites

Site relationship management is challenging no matter what, whether managing dozens of sites for a global trial with tight enrollment timelines, providing support and training for complex molecules, or building site-specific patient pathways. Understanding each site’s pain points is often a monumental task requiring a highly tailored approach, yet doing so is essential to overcoming these obstacles. It’s likely that many CROs neglect this critical step due to what is often perceived as a time-consuming and costly process. 

In addition to hands-on experience, there is a growing collection of existing data and real-time feedback from sites to help sponsors and CROs make more effective decisions about site support from the beginning. Sites report similar challenges across therapeutic areas, including: 

1. Lack of Resources

In a recent survey, sites identified staffing, study budgets, and protocol complexity as the top areas that have become increasingly difficult over the last five years.1 Specific challenges sites may encounter in the current clinical trial landscape include navigating vendor arrangements, the impact of the COVID-19 pandemic, and addressing regional conflicts that affect normal operations and the patient population. 

2. Lack of Communication

Sponsors often wonder what they can do to help sites struggling to meet patient enrollment goals. While the answer may seem simple, executing it is anything but: communication. Establishing clear lines of communication and providing the space for open conversation and feedback, including regular calls and face-to-face meetings to address questions and concerns, helps sites mitigate waste and handle change management more effectively. In addition, sites consistently mentioned a lack of communication before, during, and after the close of a trial as directly impacting their optimism and willingness to work with a sponsor or CRO again.2 

3. Lack of Training and Support

CROs and sponsors should aim to create as seamless an experience as possible for sites. Many sites have shared that they often feel they are participating in a “pilot” mode where sponsors or CROs are testing new combinations of technology tools or processes without consistency across the organization or even the therapeutic team, often leading to additional workflow disruption due to retraining and unfamiliarity. 1 A lack of support during trial operationalization, including training on study design (and redesign), budgets, and data management and handling, can add further complexities.

Learn more from PSI’s site relationship experts

The success of clinical trials hinges on the quality of the relationship between CROs, sponsors, and sites. At PSI, we know a thing or two about providing site support and meeting enrollment goals. With more than 4,000 sites worldwide that love working with us, we specialize in providing sites with the tailored resources, training, and support they need to deliver our sponsors’ pivotal Phase 2 and 3 studies. Stay tuned for tips on how to mitigate site burdens in part 2 of our series. Discover more about how to navigate these challenges and the value of site relationships by reading the complete white paper here. To learn how PSI can support your next study, contact us today.

1 Clinical Leader. (2023, April 18). Strengthening the Sponsor-Site Relationship in Clinical Trials . Clinical Leader. https://www.clinicalleader.com/doc/strengthening-the-sponsor-site-relationship-in-clinical-trials-0001

2 Hosely, M. (2021, March 23). Improving site-sponsor relationships leads to transparent clinical trials. Advarra. https://www.clinicalleader.com/doc/strengthening-the-sponsor-site-relationship-in-clinical-trials-0001

About Us

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

Case Study

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.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Putting the Focus Back on Site Relationships Part 1: Top Site Challenges  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 »