Site Relationships

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 »

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 »

medical staff running in a hallway

Putting the Focus Back on Site Relationships in Clinical Trials

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. 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.

This task has only grown more complex in recent years. 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.

Download our new white paper to learn about:

  • Top site challenges and how sponsors can help mitigate site burdens
  • How PSI’s experienced team navigates and strengthens site relationships
  • How strengthening site relationships helped one sponsor get their enrollment back on track

About Us

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

Case Study

A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of 300 global radiopharmaceutical sites. 

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 in Clinical Trials Read More »

doctor speaking with pharmaceutical sales rep, blurred background, shaking hands

PSI FAQs: How does PSI use Robotic Process Automation (RPA) to support sponsors’ clinical trials?

Recent years have spurred the clinical trial industry to embrace innovative new solutions and technologies as a way to streamline processes and continue bringing trials to patients. However, the digital transformation started long before then. PSI CRO has consistently been a leader in applying sophisticated digital solutions to pivotal phase 2 and 3 clinical trials to optimize study modeling, budgeting, and operationalization, including developing our proprietary cloud-based suite of clinical trial planning tools, INTELIA™.

This forward-thinking approach also led to PSI’s early adoption of Robotic Process Automation (RPA) as a digital solution to standardize high-volume tasks and conduct them efficiently in an error-free manner. “While doing so, it builds quality control and compliance into the processes, cutting costs by 35 to 70%,” explained Doug Shannon, RPA Technology Lead at PSI CRO, in an interview with Labiotech.

PSI uses RPA to reduce processing time, human error rate, and the amount of routine work in several areas. For instance, automating the querying of abnormal laboratory values in EDC increased on time query processing by 100%. Other functions where RPA can support clinical trials include tasks that are heavy in documentation management, such as finance and accounting, supply chain, inventory management, and back-office processes like human resources and information technology services.

RPA offers several benefits for you as a sponsor, including:

  • Freeing up PSI team members’ time to focus on your trial’s most critical tasks
  • Capturing a sequential record of each step in every process, streamlining regulatory and drug safety data, and easing the burden of regulatory submissions preparation
  • Supporting PSI’s therapeutic area subject matter experts as part of a cross-functional approach to clinical data collection, analysis, and management

To learn more about how PSI incorporates RPA and other industry-leading technologies into our global CRO services, 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. 

Case Study

A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of 300 global radiopharmaceutical sites. 

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. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How does PSI use Robotic Process Automation (RPA) to support sponsors’ clinical trials? Read More »

doctor speaking with pharmaceutical sales rep, blurred background, shaking hands

PSI FAQs: How do PSI CRAs support clinical site relationships?

At PSI, your last patient in is our first priority. Keeping this goal in mind is only possible with dedicated Clinical Research Associates (CRAs) that support your trial from end to end. This stability not only streamlines communication and transparency with your team but also with the sites who are critical to the success of your trial.

Each site on your study will have a single point of contact with one of our highly qualified CRAs, who serves as a site manager. This CRA’s responsibilities include:

• Ensuring sites are up to date and have all the essential documents
• Maintaining a deep working knowledge of the latest protocol version
• Confirming standards of care and investigator interest
• Ensuring a streamlined process of reporting
• Liaising with investigators and clinical research personnel
• Responding to site questions and providing regular remote follow-up in between visits

With experience working with 4,000 sites worldwide, we recognize that building relationships with investigators and site teams takes time. To ensure the success of each site relationship, our CRAs receive extensive project-specific and soft skills training. This difference between managing site relationships and simply monitoring sites can have a direct impact on the success of your current trial as well as a site’s willingness to work with a sponsor or CRO again in the future.

At PSI, we recognize that every patient counts. That’s why our CRAs go the extra mile to ensure our sites receive the support they need so that your study enrolls on time. Contact us today to learn more.

“I would like to thank you from the bottom of my heart for working so diligently for this patient. I know it was a lot of hard work by everyone but if you could have seen the patient’s face when I told her our site was activated it was worth it.”

About Us

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

Case Study

A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of 300 global radiopharmaceutical sites. 

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. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How do PSI CRAs support clinical site relationships? Read More »

african american doctor standing in front of other doctors

PSI FAQs: How does PSI reduce CRA staff turnover on your project?

Project team turnover can have a severe impact on your study’s timelines, leading to delays in everything from patient recruitment and site activation to data collection and study management. Clinical Research Associate (CRA) turnover rates in particular have climbed in recent years due to the COVID-19 pandemic and shifting economies, being reported as high as 30% in the US.

Despite this, PSI’s turnover has remained historically low with a company-wide staff turnover rate of only 14%. This kind of employee retention doesn’t just happen – it’s part of our commitment to stability for our biotech partners over the past 25 years.

While PSI offers competitive benefits and opportunities for employee recognition, we also support our CRAs in a number of other ways. We launched a CRA Academy to provide to help our team members develop therapeutic expertise as well as soft skills to manage key relationships with sites.

PSI also ensures that your study is effectively resourced by CRAs with manageable workloads by being selective about the projects take on. We are a specialized global CRO committed to pivotal Phase 2 and 3 clinical trials in select therapeutic areas, including oncology, hematology, gastroenterology, multiple sclerosis, and many rare diseases. This allows a more focused approach to resourcing, including providing additional study-specific training for CRAs on all new projects.

To learn more about how PSI ensures stability on your pivotal trial, 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. 

Case Study

PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. 

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. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How does PSI reduce CRA staff turnover on your project? Read More »

Strategies for Working with NGS Testing on Site in China

Did you know that NGS testing in China can be expedited with the right site relationships? 

As treatment options move towards enhanced personalization, NGS testing, or specific gene mutation testing, has become increasingly common as part of modern oncology and hematology clinical trials. When PSI Shanghai was contacted about a specific oncology trial requiring NGS testing, the team was able to contact 24 sites with relevant indication experience, and within 3 days, received interest from 15 of those sites to participate. 

In order to accelerate patient enrollment, PSI engages a trusted network of highly qualified sites to ensure that each trial’s needs are met with specific experience. Learn more about NGS testing in China with Lisa Lu, Country Manager.

If you have a phase 2/3 clinical trial requiring NGS testing, consider clinical trial sites in China. Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Discover more about our oncology and hematology experience here or contact us to speak with an expert today.

Transcript:

Did you know the NGS testing status in China?
Modern Oncology and hematology trials often require specific mutation testing, as we all move to a more personalized
medicine in time.
While this NGS technology is well established in China, it is not used in every study yet.
We still have capacity here. Let me share with you some recent cases.
We recently had a request for a specific oncology trial to be run in China. The protocol required sites being able to run the
NGS testing in screening phase. PSI’s Shanghai team contacted 24 sites with study experience in this indication.
Overall, the sites’ attitude was positive.We only had 3 days to check our sites. Among all of them, 15 sites expressed immediate interest and had the relevant
NGS experience and equipment.
The results show that NGS testing is not a show stopper for any modern trials which need this measured in China.
Looking forward to seeing you in Shanghai.

Strategies for Working with NGS Testing on Site in China Read More »

How to Boost Patient Enrollment in a Global IBD Trial

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

Details:

Therapeutic Area: IBD

Geography: 40 countries

Sites: 400

Patients: 800 (planned)

Current Status:

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

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

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

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

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

3 Steps to Empower Your Sites

  1. Create a compelling, inclusive campaign to motivate sites

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

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

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

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

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

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

  1. Build on a long-standing partnership

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

Sign up for more IBD insights from PSI CRO.

 

How to Boost Patient Enrollment in a Global IBD Trial Read More »

Strategies for Expediting Study Startup in Australia With Barrie Koh

Did you know that Phase 2 and 3 study startup times in Australia can be expedited with the right site relationships? In order to accelerate the first patient in, PSI engages private sites and medical centers to ensure an average startup timeline of only five months. Learn more about study startup in Australia with Barrie Koh, Country Manager.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, I’m Barrie. Did you know that Australia is quick to start up?

Everyone in the industry knows that it is easy to get an approval for an early-phase study in Australia. It is supported by streamlined regulatory processes, and you just need fewer documents for submissions. What most don’t realize is that startup in Phase 2 and Phase 3 isn’t that different.

The challenge is that most clients have a habit of going back to the same key opinion leaders or the huge institutions. they have lots of studies and they are heavily bureaucratic. To get to the first patient in quickly, PSI has been engaging the private sites, which are much more agile, only working with four to five huge private medical centers and a dozen more smaller sites.

With this particular approach, five months is feasible and it is consistent across all phases, all therapeutic areas and drugs classes. To cite you an example, in a recent microbiome study, we actually managed to achieve the first patient in in five and a half months at a private site down in Sunshine Coast. And this came in two weeks ahead of our planned first patient in.

Another example is a gene therapy study that we’re currently running. We were the first CRO to apply for a gene therapy license (in Australia). So we actually worked with each other to try to move this forward and this was done under four months itself and ever since then, we’ve completed four more gene therapy studies.

Strategies for Expediting Study Startup in Australia With Barrie Koh Read More »

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