News Article

Moving Your Trials To The USA? Here’s What You Need To Know.

As the biggest market under one regulation, the US is always at the top of our clients’ lists. However, not all trials are designed for US regulations. We’re here to help you decide whether the US is the best fit for your trial, and where else you might consider running your trial for the best chance of success. 

Before diving into a US-based trial, you should know these five things about getting an IND in the USA: 

  1. Start with the end in mind. Where do you want to end? Be certain of the product labeling claims, efficacy, and safety data needed for approval. With this information, you can determine the most efficient route to plan your overall development pathway and achieve your end goal. Even if you aren’t planning to take the product across the finish line yourself, it is still worth outlining the development program as if you are to help predict challenges along the way. 
  2. Hold a pre-IND meeting. You are typically granted a finite number of Type B meetings (e.g., one pre-Investigational New Drug (IND) application meeting, one pre-New Drug Application (NDA)/Biologics License Application (BLA) meeting). Be sure to avoid open-ended questions.  You should have a fleshed-out plan to present and ask the appropriate approval agency if they agree with that plan. 
  3. Go Phase 3-2-1: Outline the ideal phase 3 study or studies in the target patient population. After designing the phase 3 study (or studies), outline the early-phase studies necessary to establish the initial safety and proof-of-concept data needed before embarking on a phase 3 program. 
  4. Be strategic—utilize plans. Use strategic development plans such as a target product profile (TPP) or an integrated product development plan (IPDP) to organize your strategy. Remember, the TPP is a roadmap of a development program and the basis for annotated product labels (for marketing applications) and intended labeling claims. The IPDP includes detailed plans for clinical, nonclinical, and Chemistry, Manufacturing, and Controls (CMC) programs. 
  5. Be brave. Don’t follow the usual path. It’s easy to fall into the same strategy and game every other trial runs through. Be sure to step outside the box. Are you working with a site because it’s the best site to work with, or is it because the site is well known? Are you working with vendors that can deliver effectively and on time, or are you sticking with the same vendors that everyone else is using? Seek advice, research, and don’t be afraid to try something new. 

Looking for help planning your trial in the US? I’m here to help. Please visit my page to schedule a meeting.  

About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.  

Moving Your Trials To The USA? Here’s What You Need To Know. Read More »

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FDA Seeking Comment on New Draft Guidance on Diversity Action Plans

Increasing diversity within clinical studies, especially for historically underrepresented populations, is one of our industry’s most critical challenges today. The U.S. Food and Drug Administration (FDA) has released a long-anticipated draft guidance to assist sponsors in developing detailed strategies for reaching this key goal. Released on June 26, the draft guidance Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies is now open for comment for 90 days.

What is the purpose of the draft guidance?

The guidance provides clarity for sponsors, researchers, and stakeholders in developing Diversity Action Plans, underscoring the importance of their role in this vital initiative. “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

The guidance also encourages sponsors to consider dimensions of diversity beyond the usual definitions, such as age, ethnicity, sex, and race. Studies should seek to enroll and retain populations that are representative of the patients who will be treated if the drug is approved.

What does the draft guidance include?

The guidance covers such topics as:

  • The format and content of Diversity Action Plans, including data-based rationale and goals for study enrollment separated by population and how the sponsor plans to meet those goals and measure progress
  • The types of medical products and clinical studies that require a Diversity Action Plan
  • Timing and process for submitting plans to the FDA
  • The agency’s criteria and process for evaluating waiver requests for required plans

Which trials does the guidance cover?

As required by recent provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA), the requirement to submit Diversity Action Plans applies to phase 3 clinical studies and, as appropriate, other pivotal clinical studies of a drug or biological product. The requirement also applies to certain device trials, including those intended to serve as the FDA’s primary basis for evaluating safety and effectiveness and benefit-risk determination. Where not required, the FDA strongly recommends that sponsors implement a diversity strategy whenever possible, including in early-phase studies.

When will the guidance be in effect?

These new requirements will apply to all relevant trials that start enrollment after 180 days from the final guidance publication date. However, sponsors should begin planning early to ensure compliance.

How can I learn more?

For more information on whether your study requires a Diversity Action Plan and what should be included, schedule a meeting with PSI. PSI specializes in pivotal Phase 2 and 3 trials and has a global regulatory team to help you ensure compliance with the FDA and other key regulatory bodies. In addition, our machine-learning-powered tool VISIONAL™ makes it easy to model the optimal scenarios for enrolling key populations by comparing hundreds of country and site combinations, their budgets, and the probability of success within just a few minutes. To learn more, contact us today.

FDA Seeking Comment on New Draft Guidance on Diversity Action Plans Read More »

Pioneering Progress in Cancer Treatments [MURR Joint Publication]

This article is a collaboration with the University of Missouri Research Reactor (MURR) team and was originally published on the MURR website. Co-authors on this article are Jared Hager, Associate Director, Feasibility, PSI, and Uriah Orland, Associate Director, MU News Bureau.

From its research reactor to revolutionary therapies, Mizzou’s innovations are shaping the future of precision medicine.

Bringing a new medicine to market can be a long journey, but the potential to save lives makes it worthwhile.

Twenty years ago, the University of Missouri helped research and develop a little-known radioisotope called lutetium-177 (Lu-177). That innovation laid the foundation for clinical trials and Food and Drug Administration (FDA) approvals for a new class of drugs known as radiopharmaceuticals, resulting in thousands of successful cancer treatments.

More than 2,000 clinical trials for cancer treatments using radioisotopes like Lu-177 are now underway. In this burgeoning field, Mizzou is the essential first stop — because the University of Missouri Research Reactor (MURR) is the only supplier in the United States creating the part of these drugs that destroys cancer cells while sparing healthy ones.

“Our research reactor has been at the forefront of the development and production of radioisotopes that are saving lives every day,” said Matt Sanford, MURR’s executive director. “MURR’s innovative design and year-round operating cycle allow us to reliably produce the active pharmaceutical ingredients in multiple FDA-approved drugs. What we produce today has a direct impact on the lives and well-being of patients around the world.”

Even though only two approved radiotherapies for cancer are on the market today, these treatment possibilities represent one of the fastest-growing fields in oncology research and testing.

What is a radiopharmaceutical?

Radiopharmaceuticals use highly targeted radiation to treat or diagnose a disease. To develop these therapies, a radioactive isotope, such as those produced at MURR, is linked to a targeting molecule that seeks out certain cellular features on a tumor. The isotope, linker and targeting molecule will form a radiopharmaceutical.

“The advancement of radiopharmaceuticals has created one of the most effective forms of precision medicine to date,” said Dylan Stoy, director of Therapeutic Strategy at PSI, a CRO with over a decade of experience working with these therapies. “With applications in diagnostics, therapeutics, or ideal theranostic pairings, radiopharmaceuticals give patients and providers a great option in an ever-growing list of cellular targets and indications — and I think we are just starting to see the tip of the iceberg.”

Leading-edge science and medicine meet when the radiopharmaceutical is administered to the body and sticks to cancer cells. The radioisotopes release energy that acts as a wrecking ball to cancer cells, eventually destroying them while leaving healthy cells unaffected, unlike the radiation therapies traditionally used in cancer treatment. As a result of this advanced treatment, used either on its own or in combination with existing therapies, patients typically face fewer side effects and have greater opportunities to resume a vibrant and healthy life.

Making radioisotopes

The singular design, power and operating schedule of MURR allow the irradiation of stable isotopes to create the desired active pharmaceutical ingredient for treatments.

The center of the reactor has the highest concentration of neutrons, and these neutrons change less than one percent of a sample of ytterbium-176 to ytterbium-177 (Yb-177). Through radioactive decay, Yb-177 becomes Lu-177 in a matter of hours. A chemical process is then carried out under the FDA’s good manufacturing practices (GMP) to separate the lutetium from the ytterbium.

After the GMP process is complete, the active pharmaceutical ingredient — Lu-177 — is shipped to a pharmaceutical company for inclusion in its drug. With a half-life of 6.6 days, the entire process is designed to ensure radioisotopes produced this week will be administered to patients next week.

The long road of clinical research

Researchers join a radioisotope such as Lu-177 with two other components: a targeting molecule, which will guide the radioisotope to a specific cancer cell, and a linker, which connects the two. Each combination is tested to determine its viability. Once proven in the lab, the treatment is ready for clinical trials.

Although the timeline is lengthy and the results are not guaranteed, research and clinical trials to identify new radiopharmaceuticals are ongoing. These studies require highly specialized expertise and face many challenges — something Stoy and PSI know well. Today, PSI manages 50% of the industry’s pivotal radiopharmaceutical studies, which generate the data for drug approvals by regulatory authorities around the world.

“As the space continues to grow, it will be important to work closely with regulators across the globe to ensure reasonable access and availability,” Stoy said. “Although mapping for these products has improved significantly throughout the course of development, there are still challenges. In addition, many regulatory authorities, including the European Medicines Agency and FDA, are now working with groups dedicated to ensuring the safety of these treatments, meaning that an in-depth understanding of each specific country’s requirements is essential.”

This can be a challenge for large global studies like those PSI runs, as can the complexities of transporting radioactive materials such as Lu-177 with very short half-lives across borders in time to reach patients. Only a few nuclear pharmacies can provide the needed expertise and support for such trials.

In such cases, it’s often passionate individuals who drive this important research forward. PSI has built strong relationships around the world with more than 1,000 clinical research sites with experienced nuclear medicine teams. It has even created specialized roles to help overcome common delays during the clinical trial process. Reliable sources of manufacturing, such as MURR, will be the keystone to scalability as the field continues to progress.

Looking to the future

The success of drugs like Lutathera® and Pluvicto® has opened the door for new treatments, and researchers and pharmaceutical companies are looking at different radioisotopes and radiopharmaceuticals that can be used to treat and diagnose other types of cancer as well as diseases such as neurodegenerative disorders. Potential isotopes include terbium-161, actinium-225, lead-212, among others.

The demand for radioisotopes is rapidly increasing, and the University of Missouri is meeting the challenge. The university plans to build a new, larger, state-of-the-art reactor — NextGen MURR — which will expand the university’s capacity to produce medical isotopes that will be used in advanced cancer medicines for decades to come.


For more information, visit murr.missouri.edu or contact:

Uriah Orland
uriah.orland@missouri.edu
573-884-5139

Pioneering Progress in Cancer Treatments [MURR Joint Publication] Read More »

Top 4 Challenges in Data Monitoring Committee Management 

Managing DMCs doesn't have to be complicated.

When investigating a new drug, device, or procedure, clinical trials encounter risks to participant safety and well-being and data validity and integrity. A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is a powerful mechanism to manage these risks.

PSI defines a DMC as:

  • A multidisciplinary group set up by the study sponsor
  • Comprised of individuals with expertise in the specific indication of a clinical trial
  • Charged with regular review of clinical study data to monitor a clinical study’s safety and/or efficacy parameters.

A DMC should be independent of the sponsor and the clinical trial’s conduct. DMCs play a unique role in ensuring the safety of human subjects enrolled in clinical studies. During the past 30 years, the use of DMCs increased significantly – from 210% of trials reported in high-impact journals in 1990 to 25% in 2000 and 35% of industry-sponsored clinical trials in 2007-2010.1,2 The use and role of DMCs have also evolved, and their management has become more challenging and complicated. Among these challenges, four are particularly important for the DMC’s functioning and, in turn, the whole investigational program.

Challenge #1: Defining the need for a DMC

While there are no strict criteria for when a DMC is required, and the decision to establish a DMC in the clinical trial is ultimately the decision of the study sponsor, there is a consensus that a DMC is practical for long-term clinical studies when there is limited experience in a therapeutic area or when participants are from a vulnerable population. The FDA strongly recommends establishing a DMC if trial subjects are at risk of serious morbidity or mortality.3

PSI Solution:

PSI’s approach is that sponsors should evaluate the use of a DMC regardless of study size or study phase. When determining whether to recommend a DMC, we analyze the potential for a high overall study risk, the intervention’s complexity, and the study population’s vulnerability.

Challenge #2: DMC composition

Selection of the right DMC members is a critical part of DMC management. A poorly constituted DMC may have little credibility, while a strong committee can perform a review of the highest quality and scientific merit. To select and appoint the right DMC members, one must address such questions as the number of the members, their qualifications and experience with clinical trials and DMCs, geographical location, and independence from conflicts of interest.

PSI Solution: PSI has established a process of DMC member selection with a clear distribution of responsibilities and form templates. This process is formalized in a Standard Operating Procedure (SOP) and a Business Process Description (BPD). We have also created a database of potential DMC members (including independent biostatisticians), comprised of over 800 experts in various therapeutic areas, that can be matched to any particular study.

Challenge #3: Preparation of a DMC Charter

The DMC Charter is a guiding document for the DMC functioning that includes well-defined standard operating procedures.3 A well-developed charter allows for structured consideration of critical concepts, improves effectiveness, and bolsters trial integrity.

PSI Solution: The best practice is to use a standard template modified for the individual study. PSI has developed a DMC Charter template widely used in all clinical trials where PSI is contracted for DMC management.

Challenge #4: Meeting organization

Organization of DMC meetings involves scheduling the meetings; preparation and distribution of statistical outputs and other data required for the DMC review and specified in the DMC Charter; preparation of the meeting agenda; preparation, review, finalization, approval, and filing of the DMC meeting minutes and recommendations; and follow-up actions to the meeting.

PSI Solution: Each of these activities requires well-orchestrated efforts from the team members and should ideally be performed by professionals skilled in such tasks. PSI has established a DMC Support Group, which includes DMC Coordinators who are not involved in any other study-related activities but provide all necessary support to the DMC to which they are assigned.

Summary

Under the expert leadership of Maxim Kosov, MD, PhD, Senior Medical Advisor, PSI will assist with establishing and administrating the DMC as part of our full-service management of your pivotal study.

For more information, download our white paper How to Use Data & Safety Monitoring Boards: From Planning to Execution.

Services

  • Identification of DMC members 
  • Development of DMC charter 
  • Generation of statistical outputs and their distribution to the DMC members 
  • Administrative oversight at all stages of the DMC set-up and functioning 
  • Scheduling and organization of DMC meetings  
  • Preparation, finalization, and archiving of DMC meeting minutes 
  • Filing of all DMC-related documentation and correspondence in the Trial Master File
  • Managing payments to DMC members 

The PSI Difference in DMC Establishment and Management  

20+ years of experience in managing all types of data and safety monitoring committees. 

  • Specially dedicated independent DMC Support Group provides all organizational and logistical support to DMCs. 
  • Strong team of biostatisticians who are highly experienced in DMC statistical support. 
  • Proprietary database of potential DMC members consisting of 800+ experts from different therapeutic areas.  

1 Fleming TR, DeMets DL, Roe MT, et al. Data monitoring committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14:115–23.doi:10.1177/1740774516688915

2 Califf R, Zarin D, Kramer J. et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA, 2012; 307 (17): 1838-1847.

3 Use of data monitoring committees in clinical trials. Guidance for industry. February 2024.

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. 

Top 4 Challenges in Data Monitoring Committee Management  Read More »

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From Asia to the World: 5 Tips From The CRO That Delivers Studies on Time

At PSI, we see an exciting future for pharma and biotech developments in Asia. Smart people are creating smart ideas and innovations to change the world.  

PSI has a reputation for delivering. How do we run trials on time? 

  1. Focusing on a select few indications. This specialized focus allows us to build and maintain reliable site networks, detailed experience portfolios, and optimized process improvement strategies. 
  2. Treating our sites as clients. We believe that patient recruitment is foremost influenced by investigators, study nurses, and local site teams. PSI encourages teams by providing individualized, tailored support to local sites to increase site engagement and patient enrollment. 
  3. Creating stability and consistency. We are privately owned by the same group of people who founded the company more than 25 years ago, and we’re dedicated to delivering unmatched reliability and unparalleled support. Our teams understand that our clients come first and foster a company culture where our employees enjoy their careers and want to stay long-term. That means that the project team you start with will be the team that sticks with you throughout the entirety of your trial.  
  4. Building client loyalty. Our repeat and referral business rate is 95%. PSI focuses on working with biotech and small-to-midsized pharma companies because we understand these clients’ specific needs.  
  5. Staying accountable. 93% of all our trials ended on time or ahead of schedule in 2023. This impressive delivery rate is our claim to fame. Too many CROs fall short of expectations, and we’re working to change that trend.  

Ready to learn more about running clinical trials with PSI? I’m here to help. Please visit my page to schedule a meeting. 

About the Author: With more than 12 years of industry experience, Gavin Li is Director, Business Development, Asia-Pac, at PSI CRO.  

From Asia to the World: 5 Tips From The CRO That Delivers Studies on Time 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.
  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 »

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 »

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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 »

Benefits of PSI Global Support for Chinese Biotech Sponsors  

Deciding where to run your study can determine the success of a trial; from meeting patient enrollment and providing a positive patient journey to ensuring site expertise and a broad eligible patient population, choosing the right sites and countries to run clinical trials is crucial.

For Chinese biotech sponsors running global trials, the US is an obvious choice for running clinical trials due to the ability to collect vast amounts, and in some cases, the majority of study data, very quickly and in one place. In addition, the US is often a top choice for smaller biotechs seeking potential investors due to the visibility of trials.

However, sponsors should also consider the benefits of adding European countries to their geomix. Because many European countries have startup timelines similar to the US, adding these sites can further enhance overall timelines due to faster recruitment over a wider geographical area with additional patient populations.

PSI is a full-service CRO based in Switzerland that’s ready to support your global clinical trials with over 3,000 team members across 55 countries, spanning Asia, Europe, Africa, and the Americas. PSI has been continually recognized for excellence, including receiving CRO Leadership Awards in the categories of Expertise, Quality, and Reliability* for the past six years in a row.

Below are some additional ways PSI can provide support for Chinese sponsors as you plan your next trial:

  • Minimizing your budget: Many countries in Europe may be less expensive to run trials, with timelines just as fast as US sites. PSI uses VISIONAL™, our advanced feasibility tool, to harness the power of machine learning to provide accurate enrollment forecasting, comparing hundreds of country and site combinations and their probability of success within just a few minutes.
  • Overcoming regulatory hurdles: With our expansive European footprint and local teams, PSI can assist in navigating language and regulatory concerns such as data privacy (GDPR) from the European Union that may impact data robustness across international lines. Our regulatory experts in US and Europe have successfully supported more than 20 drug approvals in the last five years.
  • Trial design and protocol review: Designing clinical trials with the patient journey in mind and providing a plan for globalizing a trial is crucial to mitigate slowdowns further in the process. PSI’s Scientific Advisory Board can help sponsors gather detailed feedback on the overall trial design and protocol to minimize protocol amendments down the line.
  • Facilitating startup and recruitment: PSI’s Patient Recruitment and Site Support Specialists, along with our extensive vendor and site relationships, ensure tailored startup and enrollment plans at every site, especially when managing patient recruitment materials.
  • Ensuring the quality of clinical data: PSI strictly follows Good Clinical Practice (GCP) principles to run clinical trials, ensuring high quality clinical data as well as the protection of subjects. We exhibit validated quality with more than 130 FDA and EMA inspections to PSI sites, with additional successful inspections this year.

Learn more about how working with trial sites in China can help support your upcoming global study or contact us today to learn how PSI helps support sponsors around the globe.

* Overall (combined Big and Small Pharma) respondent group.

About Us

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

Therapeutic Areas

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

Applying for Multiple Phase Studies in China With Lisa Lu

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Benefits of PSI Global Support for Chinese Biotech Sponsors   Read More »