CRO industry Archives

In 2021, PSI Earns Five More CRO Leadership Awards and a Champion Award

PSI CRO, 03 MAY 2021 – PSI CRO has again received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Science Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations. In addition to the five leadership awards, PSI CRO has been named as a Champion in the category of Expertise in 2021.

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For the 2021 selection round, 60 CROs were evaluated on more than 20 performance metrics in the annual Benchmarking Survey.

“Industry Standard Research continues to consider it an honor to provide the primary market research data for Life Science Leader and Clinical Leader’s CRO Leadership Awards. ISR’s stringent screening process ensures that only highly qualified industry decision-makers participate in our CRO benchmarking market research,” says Kevin Olson, CEO of Industry Standard Research. “This is paramount as we ask the research participants to provide experiential, not perceptual, feedback on their involvement with contract suppliers over the past 18 months.”

In 2020, PSI CRO received leadership awards in the same five categories across both respective respondent groups. The 2020 award repeated the awards earned in 2019, which were a level above the 2018 award. In 2021, the addition of the Champion Award is a new recognition of our dedication to expertise. “Yet again, the tireless work of our teams around the world won the hearts and minds of our customers who gave us this resounding vote of confidence. Being recognized as a Champion in Expertise, in addition to receiving the Leadership Awards, is both gratifying and exciting; it is also a lot to live up to,” says PSI’s President, Nick Sinackevich. “We now have a new benchmark to improve upon.”

About PSI: PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees.

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

For Media Inquiries:
Kayt Leonard, Public Relations Manager
919-972-9572 | Kayt.Leonard@psi-cro.com

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

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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.

Clinical Trials Are Only Getting More Complex, and Wishful Thinking Has to Go

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It’s getting harder for sites. It’s getting harder for patients. And that’s not the only problem.

If you look at the data trends over the last decade, there’s no avoiding the truth: clinical trials are getting more complex, and every year. According to Tufts’s Ken Getz, “protocol design elements associated with protocol execution have grown rapidly” as demonstrated in a comprehensive study comparing 2010-2005 and 2011-2015. Getz and his team’s research indicated that even with the decline of some routine procedures – like blood tests – overall the cost per volunteer has grown due to a hefty increase in the total number of procedures: a 69% growth in Phase II and a 49% growth in Phase III.

Outside of Tufts, there is little discussion as to what this means for sponsors and, most importantly, for patients. It’s an ugly truth buried in proposals and budgets that many CROs are just willing to gloss over and avoid. We are asking more of patients, more of sites, and as medicine becomes more personalized and integrates more technology, the budgetary bloat easily gets out of hand.

But what does that mean for patient enrollment? Are more complex trials positively impacting patient recruitment? With no end in sight to the constant technological and data-centric “solutions” in the industry, the outcomes should be the best indication.

Getz says that’s not the case at all: “These study findings are striking given research linking protocol complexity to longer cycle times, higher numbers of protocol amendments and lower patient recruitment and retention rates. The collection of excessive and unnecessary clinical data may also compromise data integrity and analysis, lead to higher error rates, drive longer study durations, and delay submissions to regulatory agencies.”

So this steep increase in complexities isn’t actually moving the dial.

The Cost of Big Promises in the Face of Over-Complicated Clinical Trials

From the start, CROs need to be candid with sponsors about trial complexities and their ramifications in the process. It’s easy to fall into a mode of wanting to please everyone. A trial in a promising therapeutic area or with an exciting new molecule might get teams ready to bend over backward to make an appealing proposal and win business. But half-empty promises don’t lead to good relationships, repeat business, or trust. The biggest issue with over-promising and under-delivering is the impact on budgets and, ultimately, lackluster patient enrollment.

Sponsors end up burned when CROs are falling short of tackling challenging protocols, but they’re not the only ones. Patients suffer, too. Due to the collaborative nature of protocol development, it’s easy for each “piece” to fall into place but not work harmoniously as a whole. CROs should be part of the conversation, helping to advocate for protocol clarity aimed at making the enrollment process easier on the patient. Often, overlooked components of a protocol – like considering the burden on the patients from multiple angles – fall by the wayside.

Rhonda Critchlow, PSI’s Senior Director, Operations Oncology at PSI, explains: “We really should be tapping into patient advocacy groups, listening to the key opinion leaders at sites and asking: is this protocol going to be burdensome on the patient? Do we really need to do an 8 hour PK and a 12 hour PK, for example.” This means considering operational, real-world applications. Additional PK infusions mean more staff needed, more attention given to patients who will need more accommodations and a likelihood that many patients will simply feel that the ask is too high. These kinds of ramifications must be addressed early on in protocol discussions, and the right CRO will spot possible pain points.

Too many interventions may make the clinical trial unappealing to the patient who is often already under a lot of medical treatment. Unless the science is truly groundbreaking, it’s a difficult sell to patients and their families who may be on limited time as it is. And although patients receive informed consent documents, they’re often not provided enough information written in lay person’s perspective, presented in a way that clearly outlines the risks and the benefits of the trial. It puts a bit too much of the responsibility to put that information solely in the hands of investigators and site coordinators when CROs can partner with sponsors to provide that level of detail earlier on in the process.

When Technology Becomes Just Another Complication

New technologies crop up in clinical trials every few seconds, it seems, and while innovation is tantalizing – and can help smooth over difficult aspects of running clinical trials – they can also add undue complications. The trouble is that technologies aren’t one size fits all: not for every sponsor, not for every indication, not for every site, and especially not for every patient.

Working in an elderly population, for example, may end up benefiting a vendor but not actually impacting enrollment at all. eDiaries, for example, may be a roadblock for elderly patients with visual or hearing impairment or without access to the internet. Software designed to monitor taking medicine might glitch out and give false positives or negatives, putting the study at risk, when an office visit would have sufficed. The focus should never be on the technology: it should start with the patient.

The same can be said for a wide array of technological add-ons. If they’re not benefitting the patient, if they’re not going to help move the dial toward faster, more efficient enrollment, it’s important to take a very good look at the whys and hows. It’s easy to be distracted by the new and now, but just because the technology is state-of-the-art, it doesn’t mean the impact is measurable or beneficial to the study on the whole.

But Sponsors Need to be Willing to Listen, Too

Spilling hard truths that sponsors don’t want to hear can be a precarious situation. But with the right relationships, sponsors will collaborate with the CRO, especially when it comes to patient enrollment issues. “PSI never shows them the problem without giving them an alternative solution,” says Critchlow. “Sometimes the enrollment rate might be lower than what the sponsor is seeing, and not every client will not want to hear the reality. Ultimately it comes down to patient lives and costs along the journey, and that’s always our focus.”

PSI CRO Opens New Office in RTP, Continues Record Expansion

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PSI CRO, Durham, NC, 12 December 2019 – PSI CRO has officially opened its new office space in Research Triangle Park, located at 10 Laboratory Drive. This news comes after the earlier announcement that PSI CRO purchased the property at the end of 2017.

The newest space in RTP is a testament to the continued growth of the company, which caused PSI CRO to expand operations faster than originally anticipated when they launched in North Carolina three years ago. “We outgrew our projections and opened our interim space at Laboratory Drive in Q2 of 2018. For the following year, we worked across two locations until our main building on the property was completed,” says Director of North Carolina Operations, Sabine Kroher-Debuschewitz. “With the opening of our completed space, we’re able to accommodate a rapidly growing team in a region stocked with great biotech and pharmaceutical partners.”

The RTP office is just one of many that PSI CRO has opened in 2019. Since January, new locations have opened in Paris, Sydney, Tbilisi, and Shanghai.

To celebrate the opening of the RTP space, PSI CRO hosted an open house event on November 12^th to welcome in area representatives from the local RTP community. During the opening, Rhonda Critchlow, Senior Director Operations at PSI CRO, presented on Basket Studies and shared PSI’s expertise in running basket, platform, and umbrella trials globally.

“We’re fighting each day to bring drugs to market that are saving lives, and the basket trial and adaptive study approach is a must,” says Critchlow.

To learn more about the new office in RTP, and to learn more about PSI’s full-service CRO capabilities, connect with us here.

About PSI CRO: PSI is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents, and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees.

For Media Inquiries, Contact:

Kayt Leonard, Public Relations Manager

Kayt.Leonard@psi-cro.com

Patient Centricity: Buzzword or Rebirth of the CRO Industry?

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Browse through any clinical trial-focused conference agenda around the world, and you’ll see a new, hot, must-attend topic: patient centricity. At first glance, it seems relatively straightforward, right? After all, patients are literally where clinical trials happen. We ought to consider them in the work we do. That should go without saying.

Yet, and as with so many trends turned buzzwords, in spite of the popularity of patient centricity, there’s a distinct lack of clarity as to what it even means. There are dozens of articles, panels, and papers about the importance of patient centricity; new technologies spring up every day, and patient advocacy is suddenly on everyone’s minds. We’re willing to invest to look good, it seems. But try and find an in-depth critique, or deep data, on the results of patient centricity, and you’ll come up relatively empty-handed. New technology, digital enrollment, VR, or any other new trend, does not equal patient centricity. It may be part of it, but it is not the whole sum.

The truth is, our industry has avoided the voice of the patient for years. And now that it’s all the rage, we’re scrambling to look good for sponsors, investors, and ultimately, patients. You could go as far as to say that the concept of patient centricity has been obscured significantly in the last few years, diminished to little more than another sales ploy, that all-important punctuation for sponsors to help in their decision-making processes.

But it doesn’t have to be that way. The truth is that patient centricity, real patient centricity, is difficult but essential. And companies hoping to get by on the least effort are going to be in for a big surprise in the next few years if they don’t learn to adapt.

Marketing and Patient Centricity

Patient centricity, as a concept, isn’t new. In fact, it owes a certain debt to consumer marketing. In brand lingo, it’s called the customer journey, and it’s a new way of thinking of the end user first, rather than the brand’s messages or aims.

Forrester defines the customer journey as “…the series of interactions between a customer and a company that occur as the customer pursues a specific goal. (The journey may not conform to the company’s intentions.)”

In the clinical trial space, by extension, that means that the planning, protocol, goals, and means, should all consider the patient first. And though it looks very good on paper, many “patient centricity” attempts still define the trend by their own goals. Here is an example:

Patient centricity in clinical trials means designing clinical trials so their endpoints and objectives are in the interest of the patient community.

Unfortunately, the patient is significantly divorced from the actual aim in this definition: we’re talking clinical trial endpoints and objectives. It looks right on a first glance, but what does “interest in the patient community” mean, anyway? How is it measured? How does it change the goals of the trial?

Like the customer journey, patient centricity seems a natural fit in the information age. Everyone has a voice, and the digital landscape is a breeding ground for data. Simple social media searches can help predict outbreaks. Complex algorithms can break down the prevalence of certain diseases in patient populations.

But it’s not so easy to be patient-centric. It requires doing a whole lot more. According to Hensley Evans of Zs, getting pharmaceutical companies on board isn’t easy. “Pharmaceutical companies are anxious about having direct conversations with patients. There’s been so much concern about adverse event reporting, and compliance and regulatory issues,” Hensley says. It’s not just about listening to patients, it’s about being willing to make changes and adapt on their behalf. And clinical trials are notoriously bad at adapting.

The Cost of Failure Isn’t Just Measured in Dollars

That’s because the problem, of course, isn’t simply humanitarian, nor is it something that patient centricity can solve. It’s about money, time, and effort. As costs have grown exponentially, the industry has had to examine their approach to clinical trials as a whole. The interest in patient centricity arose when it became a cost issue: the demand for new drugs has surged, and along with that, general distrust from consumers regarding pharmaceutical companies (recent surveys have the distrust percentage dropping from 51% to 38% in 2018). Turning patients into products didn’t work, so now companies are scrambling to involve patients in the trial at every step, even if it isn’t working it appears to be a good selling point.

Yes, cost is one of the problems, but claiming that patient centricity is going to be a panacea is far from realistic. With only 3-5% of the population participating in clinical trials to begin with, a new picture emerges. How do we truly commit to patient centricity when we have such a low permeation among patients themselves? Patient centricity has to start before the trial, in many ways, to truly make an impact. And that means some seriously hard work on the side of CROs and sponsors in terms of their site relationships.

Throwing new technologies, new buzzwords, and new price tags on patient centricity isn’t going to solve the problem: not enough patients are involved in clinical trials, and that’s mainly due to the fact that CROs struggle to start with the patient as a person and not a point of data. When we consider the sobering facts that contribute to the larger problem, we see an even bleaker picture: about 80% of clinical trials fail to finish on time, the dropout rate is about 30%, 50% of sites fail to enroll a single patient, and a staggering 85% of trials fail to retain enough patients. As an industry, those numbers are sobering, to say the least. Not only do these factors drive up the cost of running trials globally, but when you consider that roughly 14% of drugs in clinical trials go on to FDA approval, it’s clear that life-saving medicines aren’t making it to patients in time.

Does Patient Centricity Always Mean the Patient is Involved?

Sitting down across the table from a patient might not always be the best idea, though it certainly looks good on paper (and, let’s face it, on a shiny brochure). But we’re forgetting the most important piece of the puzzle: being patient-centric means thinking about the patient, and their suffering, first and foremost. That means eliminating hurdles in the clinical trial process. Those costly delays? It’s not just sponsor’s dollars that are at stake here: it’s patient’s lives. Patients need new drugs sooner, and we’re failing them in almost every possible way, all while saying we’re trying to focus more on patients and their needs. Most CROs just aren’t willing to change and to improve their efficiencies to meet those needs.

Take site agreements. While the tedious process goes on and on, patients are literally dying before they can even participate in a trial – at that point, does it matter if they had a look at the protocol? Not for the individual who’s battling a terminal illness. Contract negotiations, according to CenterWatch, makes up $350M annually in spending. Forget dollars: that’s a ton of time.

And here’s an interesting tidbit. From the CenterWatch article, quoting Susan Caruso, WSG’s vice president for clinical solutions: “… if it takes 130 days on average to open a site in Poland and 75 in Spain… why wouldn’t you choose to go to Spain?” Does this make Spain generally more patient-centric than Poland?

The interesting question that we may want to ask ourselves is how can we as an industry become truly patient-centric by cutting out the unnecessary red tape and minimizing all the known hurdles on the way to on-time study start-up and patient enrollment. That would be really patient-centric, wouldn’t it?

What do you think about patient centricity? What does, and doesn’t, really qualify? How can we improve efficiencies in the industry?

In the coming weeks, we’re diving deeper into what patient-centricity really means. If you’re ready to hear more, sign up here and we’ll let you know as soon as the next article in the series is available.

PSI Earns Five CRO Leadership Awards

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PSI CRO, ZUG, SWITZERLAND, 15 March 2019 – PSI CRO has received CRO Leadership Awards in five categories, including Compatibility, Expertise, Quality, Reliability, and Capabilities across two respondent groups (Overall and Small Pharma). The CRO Leadership Awards are presented by Life Sciences Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI’s President Nick Sinackevich said, “Receiving the CRO Leadership Award for the second year in a row is immensely gratifying. Collecting top rankings in as many as five categories — compatibility, expertise, quality, reliability, and capabilities – makes it sweeter still. A heartfelt thank-you goes to those loyal customers who have cast their vote in our favor and, even more so, to the PSI employees who wowed the customers with their superb effort and commitment in the first place.”

The CRO Leadership Awards utilize the ISR’s Contract Research Organization Quality Benchmarking annual online survey as the basis for recognition. For this round, 60 CROs were evaluated on more than 20 performance metrics. “We believe the CROs receiving an award this year are truly at the top of their class and are deserving of this recognition. Being a top performer in any of these categories shows a level of expertise and commitment to clinical trials and serving the needs of biopharmaceutical companies and their patients.” Ed Miseta, Executive Editor, Life Science Leader.

Additionally, PSI placed in attribute awards for Data Quality, Meeting Overall Project Timelines, Technology for Access to Data, Operational Excellence, and Responsiveness.

In 2018, PSI received four CRO Leadership Awards across Compatibility, Expertise, Quality, and Reliability. The bar was raised high, and it is exciting that the company continues to grow and excel in every aspect of its operational performance.

For Media Inquires:

Kayt Leonard, Public Relations Manager

919-249-2671 | Kayt.Leonard@psi-cro.com

Small Accessories for Big Smiles

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Headbands of Hope at UC Davis Children’s Hospital

Small Accessories Leading to Bigger Smiles

“Yes, we have plenty of items. Be cool, be cool.” Our team was nervous. It wasn’t just another day at the office. In fact, it was an experience we’ve all been excited about and planning for weeks.

Every year, hundreds of thousands of children are diagnosed with life-changing illnesses. These children are asked to be stronger and braver than imaginable, battling illnesses that most adults cannot even pronounce. And while they’re in the hospital, whether for short term treatments or long term stays, their daily life and routine is in flux.

Regardless of their struggles, however, they’re still just kids. With the same kid concerns, hopes, and dreams. That’s why Headbands of Hope is so important, and why taking time to be with these kids was such a priority for the team.

UC Davis: Headbands and Smiles

“Hey, can you grab the fabric markers? We need more supplies at this table.” We set up the playroom at UC Davis Children’s Hospital with headbands and flower crowns and a few fun coloring activities, and waited for a host of children to file into the playroom. Anxiously tapping our feet, we were ready to meet awesome kids and spend a few hours distracting them, somehow, from the illnesses they were battling.

We colored. We laughed and told jokes. We got severely schooled in foosball and air hockey, and clutched to the small portions of our pride that were left after being annihilated at Hot Wheels races and Lego challenges.

Even though we left with scoreboards against us in every direction, numerous children left the room with headbands that mimicked superheroes and flower crowns that reminded each of us, and them, of the beauty they possess. And, counted in more ways than by numbers, with smiles that promised even a bit of distraction from the pain that each child was feeling.

And that distraction, even for a moment, is all that we could have hoped for.

A Grand Year, A Grander Meaning

Where did it begin? In 2018, PSI partnered with Headbands of Hope to donate headbands at children’s hospitals across the U.S. Our partnership started through a corporate initiative called the “Grand Year”, which was a task to enroll patients in clinical trials. For every patient enrolled into a potentially life-saving trial, we also wanted to give something back to the communities that we work in.

We joined Headbands of Hope to kick off our teamwork at UNC Children’s Hospital with Jess Ekstrom, founder of Headbands of Hope. To start 2019, we spent time at UC Davis Children’s Hospital with the stock of headbands, flower crowns, and activity materials. In just a few weeks, we’ll head to another hospital with the hope to spread more joy and create another distraction, if even for a moment, for the incredible children there.

Looking Ahead: It Doesn’t Stop Here

When we left UC Davis Children’s Hospital, we learned that there are more needs when it comes to these little champions. Katherine MacDonald, the programming coordinator of the Child Life and Creative Arts Therapy Department at UC Davis Children’s Hospital, talked about how events like these really help get the children out of their rooms and looking forward to social time.

“There is a major need within the program that often gets overlooked – donations for teens,” MacDonald notes. The Child Life and Creative Arts Therapy Department relies solely on donations, which can make it difficult to meet their more indirect needs, like gifts for teenage children who pass major medical milestones like completing chemotherapy or being discharged from the hospital.

Getting involved with both Headbands of Hope and the local hospitals was certainly driven from our Grand Year campaign. Moving forward, those partnerships will last throughout the years.

We All Have A Part to Play

We all can do our part to push for more smiles, to encourage hope, and to offer distractions from the painful illnesses that children around the world are battling. With more than 300,000 children diagnosed with cancer each year alone, there’s a lot of work to be done. And that large 300,000 number? Remember, that’s only in cancer-related illnesses. Factor in a few more diseases, and that number instantly skyrockets.

At PSI, we’ll continue partnering with Headbands of Hope to make an impact. And we challenge organizations globally to do the same. Because at the end of the day, it’s needed. And the smiles from something so small, will mean something so grand.

The UC Davis Children’s Hospital + Headbands of Hope event was attended by PSI teammates Tibor Kovacs, Andrea Cracraft, Ken Zib, Shaun English, Mindy Chu, and Kayt Leonard. Together, we are #PSIProud

Clinical Trials In The EU? Here’s What You Need To Know.

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What do you know about transitioning clinical trials to Europe?

Moving your trial to the EU is no small task. With regulatory agencies, varying approval parties, and different norms and standards in patient populations. Before entertaining thoughts about a trial in EU, you should know these 5 things about getting the Clinical Trial Application (CTA), and beyond.

Before diving into a EU-based trial, you should know these 5 things about getting a CTA in the EU:

IND (USA) and CTA (EU) have substantial differences. You will need only one IND per drug development program, but you must achieve one CTA for each study.
Europe is diverse. Despite efforts to harmonize procedures, there are many differences across Europe. Even within a country, the deadlines for getting approval can differ. For example, in Russia, If you receive questions, the duration of approval will increase significantly. Observations show that getting questions back is a result of the indication and the quality of your submission package.
Double check your feasibility. Run a good feasibility check where the study comparator and/or original drug/treatment is reimbursed. A familiar example is a study with biosimilars – while the Western European countries will show little to no interest, these studies are searched for by select Eastern European countries heavily.
Consider production and drug import locations. Depending on the production location, import can be tricky. Any good and reliable partner should work with you to balance overhead in local drug depots or at sites versus the number of shipments. To learn more about our drug supply principles, head to PSI On Point and learn about the Seven Deadly Sins of Trial Supply Management by PSI’s own Alan Morton.
The underestimated task – translations. With the diversity of European language networks, you need to plan a budget and time for translations. If you require back-translations, this can become even more burdensome. Make sure you plan this out in advance.

Ready to learn more about clinical trials in the USA? Don’t forget – we’re here to help.

About the Author: With more than 20 years of industry experience, Christian Buhlmann is Head, Business Development Europe, and Asia-Pac at PSI CRO.

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

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What do you know about transitioning clinical trials to the U.S.?

Transitioning clinical trials to the US is no easy task. As the biggest market under one regulation, the US is always at the top of our client’s list. However, not all trials are designed for US regulations. It’s time to learn about where your trial actually has the best chance for success.

Before diving into a US-based trial, you should know these 5 things about getting an IND in the USA:

Start with the end in mind. Where do you want to end? What’s the final outcome? Be certain of the product labeling claims, efficacy, and safety data needed for approval. With this information in mind first, you can then 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, you should outline the development program as if you are.
Hold a pre-IND meeting. Myth buster: The Agency IS NOT your enemy. But, put your best foot forward and use meetings wisely. You are typically granted a finite number of Type B meetings (e.g., 1 pre-IND meeting, 1 pre-NDA/BLA meeting). Be sure to avoid open-ended questions. The Agency is not your consultant. You should bring forward your plan and ask the Agency if they agree with that plan, instead of asking for their ideas on what your plan should become.
Go Phase 3-2-1: Be sure to outline the ideal phase 3 study or studies in the target patient population first. After designing the phase 3 studies, you can then outline the early-phase studies necessary to establish the initial safety and proof-of-concept data that is needed before embarking on a phase 3 program.
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, TPP is a roadmap of a development program and the basis for annotated product label (for marketing application) & intended labeling claims. The IPDP includes detailed plans for clinical, nonclinical, and CMC programs.
Be brave. Don’t follow the usual path. It’s easy to fall into the same strategy and game that every other trial runs through. But, 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 actually deliver against timelines, or did you stick with the same vendors that everyone else is using? Seek advice, do your research, and don’t be afraid to try something new.

Ready to learn more about clinical trials in the USA? Don’t forget – we’re here to help.

About the Author: With more than 20 years of industry experience, Christian Buhlmann is Head, Business Development Europe, and Asia-Pac at PSI CRO.

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

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What do you know about running trials 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.

We know that it’s a tricky move to go beyond one’s own turf and explore opportunities in new locations. And we’ve seen companies struggling to master their trials in both Europe and the US. But you can count on PSI to provide the tools and info to explain, step by step, five of the biggest hurdles to overcome when expanding your trials beyond Asia.

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

Focusing on a few indications only. As a recipient of this e-mail, your research topics fall into our indication coverage. This focus allows us to build reliable site networks, detailed experience, and expertise, and speed up processes.
Treating our sites as clients. We believe that patient recruitment is foremost influenced by the investigators, study nurses, and the team on site. PSI allows its teams to support the sites beyond normal, baseline standards. In the 2015 and 2017 CenterWatch surveys, sites rated PSI as top CRO.
Creating stability and consistency. We’re dedicated to service and delivery. Our teams understand that our clients come first. In parallel, we establish 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.
Faithful clients. Our repeat business rate is greater than 90%. PSI mainly works with biotech and small-to-midsized pharma companies. We understand the culture and the different needs of these clients. And they continue to work with us.
Measured by delivery. More than 90% of all our trials end on time or ahead of schedule. This impressive delivery is our claim to fame. Too many trials fall short on expectations, and we’re working to change that trend.

Ready to learn more about clinical trials in Asia? Don’t forget – we’re here to help.

About the Author: With more than 20 years of industry experience, Christian Buhlmann is Head, Business Development Europe and Asia-Pac at PSI CRO.