News article

3 Steps for Transitioning Ongoing Studies to the EU Clinical Trial Regulation

After being adopted by the European Parliament in April 2014, the European Union’s Clinical Trials Regulation (Regulation (EU) No 536/2014) officially takes effect on January 31, 2022. The regulation aims to improve the harmonization of the approval process for clinical trials and make the region more attractive as a destination for clinical research.

If you are a sponsor of active clinical trials in the European Union, you may have additional responsibilities under the new Clinical Trials Regulation. But don’t worry. Here are the steps for transitioning an active clinical study in the European Union to the new requirements under the EU Clinical Trial Regulation. For a more in-depth look at the changes, you can read our new white paper A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies.

Steps for Transitioning Ongoing Studies

  1. Sponsor Evaluation
    • Evaluate your clinical trial’s current compliance with the Clinical Trial Regulation and identify the need for transition
    • Determine whether the dossier needs to be harmonized between Member State Committees
    • Confirm if the clinical trial is eligible for transition (no pending/ongoing assessment in any EU or EEA countries)
  2. Harmonization
    • Harmonize dossiers via SA application according to CTD
  3. Transition
  • Make formal application for transition (simplified dossier, no re-assessment!) in the new Clinical Trial Information System
  • A new cover letter and new application form module are required to be completed in CTIS (see Figure 1)
  • For multinational clinical trials: Sponsor’s declaration that part I/part II documents do not contain significant differences/are identical to the versions approved by each Member State (as applicable)

Figure 1. Documents required to be uploaded in the CTIS for transition

The standard timeline for the review of the transition application is 60 days. During this period, the trial cannot be amended. If and when the trial undergoes the next substantial modification following the date of applicability, the full requirements of the new CTR will apply.

As a privately owned and operated contract research organization headquartered in Switzerland, PSI CRO has continuously monitored and adapted to the changing European regulatory landscape over the last 25 years. Drawing on this experience, we can offer a unique perspective on preparing for this shift in how clinical trials are conducted in the EU. Click here to read our new white paper and get in touch with one of our regulatory affairs experts.

A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies

With the European Union’s Clinical Trial Regulation coming into effect on January 31, 2022, we know there are many questions when it comes to what’s changing and what you need to do to comply. That’s why PSI CRO, drawing on our 25 years of experience managing studies across the globe, is sharing our insights in a new white paper.

In A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies, you’ll learn:

  • The new elements introduced by the EU CTR
  • The applicability for current studies
  • How to transition your study to the new requirements

Click the image below to start reading or download a copy.

Case Study: Cutting Startup Timelines in Half on a Global HemOnc Study

The world is changing rapidly, but some things are as stable as ever—like our preoccupation with growing a network of productive study sites across oncology and hemonc indications.

Each dot is so much more than just a data point: it’s PIs and site staff showing up and supporting our studies every step of the way, from planning to execution, all around the world. We couldn’t do it without them.

Picture this: you need to enroll a 900-patient hemonc study on a tight timeline. You want a CRO that’s absolutely obsessed with getting it right. And that’s how we did it here. 

Finding the right sites and completing site identification for such an extensive study in half the time was only possible through the dedication and perseverance of our feasibility, site identification, and startup teams. They’re the backbone of making projects like this happen, working alongside our global sites supporting the study startup process to ensure we avoid costly delays—even amidst an ongoing global pandemic.

“When the pandemic first arose, PSI quickly set up a COVID task force that included tracking the ongoing status of all our sites,” said Diana Fowler, Head of Study Startup:

“We knew which sites were open to recruitment and onsite visits, which were allowing remote monitoring visits, and which were completely shut down. With a planned first site activation date of April 2021 for this study, we worked closely with sites to understand how the pandemic affected their ability to meet the planned dates. We also offered them several technical options that allowed us to conduct site selection visits remotely.”

In addition, the regulatory activities were closely monitored to ensure that no time was lost between receipt of approval from one agency to the submission of the next.  With this close oversight, PSI not only managed to meet first site activated as planned but, within six business days, also activated a total of four sites in two countries.

We’re grateful for recognition, and we appreciate our sites, our employees, and our vendors, for the dedication and support they give us, day in and day out.

In the end, it’s all about how patient enrollment pushes forward—actual vs. planned. The story begins with startup. Every day we can save on site identification and startup activities brings patients that much closer to potential treatment. One patient at a time, we’re here to add predictability to your enrollment timelines, no matter what.

#EveryPatientCounts is your vaccine against uncertainty.

Three Years Strong – PSI Awarded Best Place to Work

We’ve done it again: For the third year in a row, our team in King of Prussia, Pennsylvania, has qualified and won the title of Best Place to Work by the Philadelphia Business Journal.

We were honored with this title in 2019 and 2020. Even through the changes and challenges that came with the COVID-19 pandemic, our King of Prussia team was able to grow and nurture a welcoming culture that promotes teamwork and personal growth.

Winning in this region is no small feat. King of Prussia is home to several of the top clinical research, healthcare, and biotech companies.

We’re inspired by the employees that embody our company’s values each day and build a culture that welcomes new talent and encourages constant professional growth. Having a team willing to step up to each challenge with enthusiasm and a positive outlook allows PSI to make a difference by delivering quality clinical trials on time and on budget.

To learn more about the award, and the meaning behind this local badge of fame, click here. And to join the team that truly is among the best of the best, search our careers page and submit your application today!

To our entire team in KOP, and to the global team who helps make this recognition possible, congratulations! We’re #PSIProud of the work you do each day.

Hear From Our Team: #WhyIPSI

Have you ever thought of joining the team here at PSI CRO? In the past few months, we started asking our teams: what’s your favorite part about PSI CRO? In a world where options are endless, and talent is in high demand, we know that we have experts on staff that are best-of-the-best. And they’re telling us why they’re #PSIProud to be part of the team through our series of #WhyIPSI posts this year! To kick things off, take a look at a few of our testimonials below. Each month, check back to see more testimonials, and even a few familiar faces!

Hear some of the stories of the individuals who we’re lucky to call teammates: “I was fresh out of university and studied Human Genetics and Clinical Pharmacology when I was exposed to clinical trials. The opportunity arose at PSI where I could start my career in the field. I love how close the teams are throughout the company, regardless of where you are. I have transferred from South Africa to Australia, and the company still feels like home. It’s #WhyIPSI.”

Charlotte has been with PSI since 2014 and has been instrumental in building up our team in Australia. We’re lucky to have her.

“I always wanted to get into the CRO industry. Five years ago, a friend recommended PSI for their culture, but I was hesitant because I would have to move. But in the end, while leaving my family and city was difficult, the whole team was so friendly, helpful, and solution-driven that they have become my family. It’s #WhyIPSI.”

Brenda has been an instrumental member of our PSI South African team since her joining in 2015. We’re lucky to celebrate almost 6 years of her hard work.

“I wanted to work for an organization that has a strong company culture. I love that PSI is supportive of their employees, and I enjoy working cross-departmentally to grow PSI’s workforce. It’s #WhyIPSI.”

Madeleine hit the ground running when she joined our team in 2018 recruiting top talents. She’s as busy as ever as we continue to grow rapidly in the USA and across the globe. Interested in joining the PSI team? Reach out to Madeleine!

Thank you to all our employees for sharing #WhyIPSI. Stay tuned for additional stories from our team members.

Thank you to all our employees for sharing #WhyIPSI. Stay tuned for additional stories from our team members.

If this sounds like a team you’d like to be part of, check out our careers page. We’re hiring all across the globe in multiple departments. From clinical trial administrators to data managers, grow your career with us.

PSI Celebrates Rare Disease Day 2021

Each year on the last day of February, EURORDIS partners with organizations globally that specialize in rare diseases to celebrate Rare Disease Day. The day aims to bring attention to the more than 6,000 rare diseases that affect over 300 million people each year.

According to EURODIS, rare diseases currently affect 3.5% – 5.9% of the worldwide population. That’s over 30 million people in Europe alone but still research and quality information on the diseases are lacking and result in a delay of diagnosis. For a majority of rare diseases, there are no existing cures.

PSI works in the rare disease space regularly with trials in Hemophilia, Willebrand Disease, Paroxysmal Nocturnal Hemoglobinuria (PNH), and many more. We dedicate the work we do every day to improving the lives and treatment options for those battling against these diseases.

To show our continued support to researchers, patients, and caretakers alike, we asked our PSI team to share why promoting research in rare diseases was important to them:

To me, it is a bit personal as I have some stories of rare diseases among my very close friends. And I want people with rare diseases to feel that they are not alone and, we’ll find a solution altogether.
Yuri Titov
Country Manager, Hungary
Helping to find cures for rare diseases means everyone has a shot at a better quality of living. Many rare diseases are based on genetics. As a person with a large family, finding out how genetics play a role in rare diseases is important to me.
Kelly Spaulding
Digital Strategist
I worked in rare disease research for over six years in former monitoring and project management jobs. I am grateful for the laws passed previously for orphan drugs to ensure pharmaceutical companies can bring these products to testing and the market while still staying viable as a business. However, I saw firsthand the importance of giving individuals and their families hope. One of the things that get me up every day and coming to work is that research and the treatments we help facilitate gives people options and gives them and their families hope and a way forward.
Ladonna Mullins
Senior CRA
Rare disease research is important to me because everyone deserves to have the chance for a cure or improvement in their quality of life.
Joseph Mullen
Business Development Associate
Because everyone needs to have the same opportunity!
Iara Souza
Office Management Specialist
Research into rare diseases is important to us in order to give hope to those who need it most.
PSI Italy
There are many people suffering from the lack of diagnostic tools and treatments!
Oscar Podesta
Head of Latin America
Until there is a cure, there need to be different treatment options, and we need to help the patients through research.
Adriana Macia
Senior CRA
Because life is rare!
Maria Blasco
Regulatory Officer
As a survivor of cancer that is treatable, it is important to me that we find cures and treatments for all disease, and rare is no exception!
Carrie Gable
Director of Business Development
Finding the cure for rare diseases is important to me, as it should be for everyone, because we, as humanity, are all intertwined, like a living, breathing chain. As such, we are only as strong as our weakest link - make that link better, and all of humanity benefits. Cure that single branch, and the tree will thrive.
Avi Gibly
Senior CRA
We can do such amazing things with medicine that it's only right that we fight to improve every life.
Allison VonCannon
Events Coordinator

Rare Disease Day might only last 24 hours but aim to provide 24 hours support to those battling against a rare disease. To learn more about rare diseases, Rare Disease Day events near you, and ways that you can get involved, visit www.rarediseaseday.org. To learn more about current research efforts, orphan drugs, and rare disease policies, visit www.eurordis.org.

Celebrating World Cancer Day 2021

Each year on February 4th, The Union of International Cancer Control (UICC) partners with organizations across the world to celebrate World Cancer Day. With a global reach and an audience far and wide, this day is the leading initiative to raise awareness, improve educational outreach efforts, and encourage collective action to work towards a cancer-free world. During World Cancer Day, the UICC encourages everyone to share the driving passion behind why they are dedicated to ending cancer.

We asked the PSI team to share their stories – what’s their personal experience with cancer? What inspires them to work towards a cancer-free world? As a team truly committed to the mantra of “Every Patient Counts,” we knew responses would flow. We knew that our PSI team was, and is, deeply connected to the industry we work in. The responses we got were humbling and heart-warming:

“World Cancer Day is very important to me as I remember my dear friend, Adam Krief, of blessed memory. He fought and subsequently lost a battle against Primary Myelofibrosis at the tender age of 33. In the process, he inspired thousands to join the Global Bone Marrow Registry – which has led to over 180 matches and 20 transplants. May his memory continue to be a blessing!”  – Jeremie Braun, California, USA. 

“My mum lost the battle to breast cancer after fighting it for seven years. Having witnessed the pain that she endured with the disease and treatment, I do not wish that upon anyone else. Until a cure is found, I will continue to be an advocate for cancer research and education on preventative actions.” – Justine Lee, Sydney, Australia. 

“I lost a very dear friend to cancer three years ago. She was such a fighter, and I saw the pain she had to endure every day for two years. Unfortunately, she lost the battle, but she is remembered for the courage and strength she had. I need to be part of any Cancer awareness campaign — supporting the Fighters, admiring the survivors, honoring and remembering the taken and to those that are still fighting never give up hope!” – Odenda Joubert, Pretoria, South Africa. 

“My dad was diagnosed with stage 4 prostate cancer when he was 54 and fought like a trooper taking part in two clinical trials which brought his PSA levels down significantly extending his life expectancy. Sadly the disease took hold, and he didn’t make his 60th Birthday. Being a witness to the pain and suffering that no one should go through, I am a huge supporter in the fight against the dreaded C word! “– Hayley Greenaway, Oxford, United Kingdom.

“To me, World Cancer Day is a day to celebrate cancer research and help increase awareness for cancer screenings. Through early screenings, my guardian is winning his decade’s long fight with testicular cancer, along with many of my aunts and uncles. Early and frequent screenings save lives, so know the signs and get screened! “– Joseph Mullen, North Carolina, USA. 

At PSI, we’re proud to be part of the battle against cancer. But it’s on all of us to learn more, get involved, and do our parts to further education and research. Learn more about World Cancer Day. Together, we’ll end this disease.

“Cancer took my best friend of 32 years. There isn’t a day that goes by that I don’t think about her and wish for one more hug. I am in this fight and will continue to be until no one else has to endure the heartache of losing their best friend. Love & miss you, Mom.” – Chris Budny, RTP, NC, USA

“My best friend and hero passed away last year after two bouts with breast cancer.  My Mom was determined to beat this disease and in her honor, I will continue her fight against cancer until we can find a cure.” – David Cass, Boston, MA, USA

“My mother passed away from breast cancer nine years ago. She remains my rock even now. In the back of my mind, I always hear her voice urging me onward. She was my best friend and I lost her too soon. So in her honor, I will always strive to make a difference in the fight against cancer.” – Susan Griffith, RTP, NC, USA

“Just a few weeks after her 50th birthday, my mom was diagnosed with an advanced form of ovarian cancer. The news came as a huge shock – but cancer doesn’t discriminate. Cancer doesn’t care how old you are, how active you are, or who you are. She’s a fighter, but not everyone has the opportunity to fight. It’s on all of us to raise awareness, advocate, and push research ahead. And until there’s a cure, we can’t slow down.” – Kayt Leonard, Raleigh, NC, USA

“After the loss of my dear old dad to colorectal cancer two years ago, I have been struck by the number of stories I hear about the increasing number of younger people being affected by the disease. I am determined to do my bit, to support the development of effective treatments so that we can stop the suffering of patients and their families and friends.” –   Helen Nelson, Oxford, United Kingdom

“Dr. Phillip M. Carter is a professor of Linguistics and a powerhouse of social justice in Florida.  He is also a cancer survivor and a light for anyone who has the honor of knowing him.  I do the work I do know thing that the quality of people’s lives are made better because of who he is and the work he does.  This would not have been possible if he had not survived testicular cancer. ” – Kelly Spaulding, RTP, NC, USA

“My daughter Ireland was diagnosed with a brain tumor at 14 months.  She was lucky as the tumor was very rare, and benign. Since this time, I have had many family members and friends who were not so lucky and lost their life far too early.  Cancer doesn’t stop in the midst of a pandemic! I’m thankful to work at PSI, they are committed to oncology research and live the motto #everypatientcounts especially in oncology trials.” – Brenda Reese, CA, USA

“My best friend and hero passed away last year after two bouts with breast cancer.  My Mom was determined to beat this disease and in her honor, I will continue her fight against cancer until we can find a cure.” – David Cass, Boston, MA, USA

“I am proud to be part of the fight against cancer.  This terrible villain has caused so much heartache to my family.  It has attacked family members of all ages.  For those loved ones I’ve lost and to those loved ones still fighting a good fight, I am honored to belong to a group that is dedicated to finding a cure.  My two cousins and a friend are currently in remission due to the progress we have made.” –Nicole Legler, Tampa, FL, USA

“Back in 2008 I had an excruciating headache and ended up going to the ER to receive a spinal tap and CAT scan.  The ER Doc told me that my spinal fluid was clear and he couldn’t see anything remarkable on the scan.  Luckily, my dear friend was a neurologist and insisted I have an MRI.  I soon came to find out that I have a brain tumor called an acoustic neuroma and it wasn’t small.  I ended up receiving radiation from a wonderful technology called Cyberknife and the tumor is slowly collapsing.  I am thankful every day for the research and brilliant minds that work every day to find an answer and as such, I have had many more years with my two sons.” – Carrie Gable, San Diego, CA, USA

At PSI, we’re proud to be part of the battle against cancer. But it’s on all of us to learn more, get involved, and do our parts to further education and research. Learn more about World Cancer Day. Together, we’ll end this disease.

Our Vaccine Against Uncertainty

Are you tired yet of reading about what “unprecedented times of uncertainty” we’re living in? Me too. As if there have ever been times of certainty. Though, admittedly, 2020 has been provocatively forthcoming with multiple uncertainty reminders.

Whenever anyone of us gets worked up about it – too much COVID, too much work, too little time – we have to turn back to the PSI mantra. It has now gained a whole new meaning.

“Every Patient Counts” is PSI’s vaccine against uncertainty.

It has served us well over the years, and it’s been serving us well in 2020. Some things don’t change, not yet, anyway. People still need their pivotal trials to complete on time, now, perhaps, more than ever.

Here’s this month’s patient enrollment graph in onco-hematology: 22 countries around the world, with the enrollment of 469 patients completing slightly ahead of schedule. Not surprisingly, this returning customers is returning again with a new study. Many years together and many more to come, we’ll make sure of it.

What is happening with your pivotal trial? Reach out to discuss, because every patient counts, and so does every minute of every day that goes by without improvement.

#EveryPatientCounts #Oncology #Hematology #OnTimeEveryTime #Onwards

 

 

PSI CRO Named Best Place to Work in Philadelphia Business Journal

 

What’s better than being named a Best Place to Work? Well, only one thing: receiving that same title two years in a row.

In 2019, our team in King of Prussia, Pennsylvania qualified for and won honors as a Best Place to Work by the Philadelphia Business Journal. Based in a region stocked with top companies and rockstar talent, this recognition was a true honor for our #PSIProud employees who approach every day with the mindset to make a difference and deliver clinical trials on time, on budget, and on quality.

And in 2020, that mindset, and the actions around that mindset, remained strong. For two years in a row, the KOP office is ranked as a Best Place to Work!

 

To learn more about the award, and the meaning behind this local badge of fame, click here. And to join the team that truly is among the best of the best, search our careers page and submit your application today!

To our entire team in KOP, and to the global team who helps make this recognition possible, congratulations! We’re #PSIProud of the work you do each and every day.

 

 

Of Course Your Clinical Trial is Delayed: Ready for a Divorce?

Even if your trial wasn’t already delayed before COVID-19, it probably is now. And although the world is slowly going back to “normal”, it’s going to take a new kind of resilience to catch up and get back on an acceptable track. In light of the pandemic and looming revenue plunges, many CROs started reduced their workforces early on, making steep cutbacks, and introducing hiring freezes.  With so many CRO folks laid off or fearing for their jobs, who and how is going to step up and to take care of the enormous backlog? The authorities did their best to jump in and ease up the stringency on protocol deviations during the pandemic. Tech providers came up with a few on-line solutions to substitute physical presence. And yet the bulk of the make-or-break work to spike up that patient enrollment graph is in the hands of CRO clinical teams and their tenacity and result-oriented style of working with the sites. All this is to say, it’s the perfect time to question whether your CRO has the grit, the stable study team, and a trust-worthy plan to transition from a delay to a more-or-less timely LPI without sending the cost of your trial through the roof. No surprise that these days we are seeing a considerable uptick in requests to transition or rescue entire pivotal studies and phase III programs away from former CROs. And there is a lot more observable agility about making CRO transition decisions.  Just like divorce rates spiked after the weeks of lock-down, sponsors have become much more resolute about making CRO changes here and now.

It’s hard, but not as hard as you might think

Just like a divorce, it can be an emotionally draining experience, though it doesn’t have to be. If your new CRO has well-established transition processes, checklists, per-country requirements, ample support from in-house regulatory and legal staff savvy in CRO transition particularities in each of the involved countries, and a good plan for how to communicate with the sponsor and former CRO for the next few months, you’ll be fine. Having taken part in hundreds of rescues and dozens of major full-service take-overs we have established SOPs, detailed processes and smooth communication techniques to facilitate the transition. Our 7-Step CRO Transition Program has been run and tested on several pivotal transitions just in the last few years, resulting in increased enrollment rates and reduction of the overall study timeline every single time.

Your CRO keeps changing people?

Great enrollment should be largely attributed to great site relationships – specific people at the CRO having built trust and rapport with specific people at the trial site, and these specific CRO people being available to work on your study. No amount of expensive technology or promised access to patient banks can replace the good old power of a strong human connection. If the investigators are not excited about working with your CRO (meaning CRO’s specific people visiting, calling on, talking to their site staff), chances are they may not be that excited about enrolling patients in your study. When we are asked to assess the enrollment potential of a lagging study, we would always take into account whether the right sites had been chosen to begin with and, if so, have they been nurtured enough to produce results. You’ll be surprised how easy it is to tell after a careful glance at the site list and a few conversations with the site staff why enrollment hasn’t been quite happening. Often, just like Sponsors, the sites point at the unfortunately high turnover of people they are dealing with on the CRO side. It doesn’t have to be the lasting fate of your study. And if it is, come talk to CROs who are known for exactly the opposite: very low staff turnover rates and top investigator ratings. I bet these two are somehow connected.

Where does one find a stable CRO these days?

In Switzerland… Just kidding. Well, maybe not. Everything is stable in Switzerland, they might as well have stable CROs! Look for someone who’s privately owned by management and doesn’t have to report to anyone but themselves, never borrowed a dollar, has always been fully self-financed through clinical project work, has grown into a global organization by meticulous hiring, training, and cultivation of company culture, has a great reputation (you find that out by talking to their clients) and are known for uncompromised focused on delivery and service. If you find them, chances are you are finding a partner for life. About the author: Olga Alfonsova has been with PSI from day one and has overseen launches of dozens of CRO transitions. If you’re a sponsoring company considering a CRO change, you can reach out to her for a free consultation by leaving a comment here or through her LinkedIn page.