Drug Development

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

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

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

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

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

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

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

globe view of asia

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

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

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

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

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

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

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

IBD patient enrollment

Top 4 Sponsor Challenges in IBD Patient Enrollment

The number of IBD clinical studies grows each year; however, the number of patients enrolling in these studies has not increased proportionally. Instead, patient enrollment rates for IBD trials in recent years have shown a significant decline: from 1998 to 2018, the average recruitment rate in moderate-to-severe UC decreased from 0.32 to 0.13 patients per site per month, while the average recruitment rate in moderate-to-severe CD decreased from 0.65 to 0 to 0.10 patients per site per month.i

In PSI’s white paper Inflammatory Bowel Disease: Current Status and Future Perspectives, Senior Medical Advisor Maxim Kosov breaks down recent trends in IBD clinical research, including insights into patient recruitment and retention. Read on to discover the top four challenges to consider when enrolling IBD patients for your next trial.

1. Availability of Existing Treatments

The success of FDA-approved treatments, particularly vedolizumab in 2014, ustekinumab in 2016, and tofacitinib in 2018, often leads to a decreased patient enrollment rate in placebo-controlled randomized controlled trials. When the currently approved drug provides effective treatment with minimal side effects, patients will often opt for this method instead of enrolling in a study where they may receive a placebo drug. This is often a leading factor contributing to slow enrollment.

2. Competition Between Trials

When it comes to site choices and geomix, many sponsors and their partners approach larger academic centers first, assuming that these sites will have more experienced staff and equipment. One study found patients followed at academic centers are almost twice as likely to have participated in randomized clinical trials. However, the study also found over half of enrolled patients were followed in private practice settings.2 Focusing on large institutions leads to higher competition rates. For instance, as of October 2022, in the University of California San Francisco alone, there were 29 active IBD clinical trials, and 9 of them were enrolling.ii

3. Country and Site Selection

Additional factors may influence low enrollment potential, including site choice and geomix. When choosing the right geomix of sites, sponsors must consider the incidence of the disease, treatment standards, and availability of the medications. The incidence of IBD is increasing in Asia, Africa, and Latin America, driving interest in shifting clinical trials to these regions.iii Additional factors to consider when selecting sites include the health insurance environment (the likelihood that insurance companies will approve less efficient generic medications over specialty ones) and the presence of preferred study sites (sites with whom the CRO has a long history of cooperation and appropriately trained study teams).

4. Screen Failure Rates

Over the past decade, screen failure rates in IBD trials have grown, approaching 50% in UC and 70% in CD, primarily due to failure to meet minimal endoscopic or biomarker criteria for active disease and a growing list of exclusionary concomitant medications. In PSI studies, we’ve seen a screen-out rate of 26-48% in UC and up to 64% in CD.

Some general recommendations to minimize screen failure and aid in patient enrollment rates include higher drug-to-placebo rates (such as a ratio of 2:1 or 3:1 rather than 1:1), broader use of patient-reported outcomes as the primary study endpoint, and optimization of study visits’ duration and complexity (including fewer procedures and endoscopies). Additional options for trial design include adding a long-term open-label extension for patients responding to therapy, and more involvement from the patient’s primary GI physicians at local hospitals and private practices. Primary care doctors see patients at the earlier stages of the disease course. There is a better chance that such patients are more likely to meet eligibility criteria than those admitted to larger hospitals or academic institutions, where the disease is often more severe and potential complications more frequent.

global map of PSI IBD sites with teal dots as markers
PSI has built and nurtured a database of 3,900+ sites in more than 50 countries across the globe to identify the ideal geomix for your study.


IBD patient recruitment and retention depends on the study protocol criteria and complexity, which must be scientifically sound to achieve the goals of the study as well as being attractive to patients. PSI provides a thorough review of the protocol by internal therapeutic area experts and harnesses the power of AI and machine-learning through our INTELIA platform, combined with strong site relationships around the globe, to ensure your study meets enrollment goals. If you’d like to learn more about PSI can support your global Phase 2 and 3 IBD trials, click here.  

i Harris, M. S., Wichary, J., Zadnik, M., & Reinisch, W. (2019). Competition for clinical trials in inflammatory bowel diseases. Gastroenterology, 157(6), 1457–1461. https://doi.org/10.1053/j.gastro.2019.08.020

ii Heyman, M., Terdiman, J., Lewin, S., Verstraete, S. G., & Mahadevan, U. (2022, November 7). UCSF inflammatory bowel disease clinical trials – San Francisco Bay Area. UCSF Clinical Trials. Retrieved November 21, 2022, from https://clinicaltrials.ucsf.edu/inflammatory-bowel-disease

iii Ng, S. C., Shi, H. Y., Hamidi, N., Underwood, F. E., Tang, W., Benchimol, E. I., Panaccione, R., Ghosh, S., Wu, J. C., Chan, F. K., Sung, J. J., & Kaplan, G. G. (2017). Worldwide incidence and prevalence of inflammatory bowel disease in the 21st Century: A systematic review of population-based studies. The Lancet, 390(10114), 2769–2778. https://doi.org/10.1016/s0140-6736(17)32448-0

Top 4 Sponsor Challenges in IBD Patient Enrollment Read More »

PSI CRO selected by POINT as preferred partner to lead clinical trial program

POINT Biopharma Announces Phase 3 Prostate Cancer Trial, Selects PSI as Preferred Partner to lead Clinical Trial Program

TORONTO, May 12, 2020: POINT Biopharma Inc. is pleased to announce the selection of PSI CRO to manage its phase 3 clinical study of PNT2002, a 177Lu-PSMA radiotherapeutic for the treatment of metastatic castrate-resistant prostate cancer. 

“PSI CRO is a leading, full-service, global clinical research organization, and is excited to be selected as the preferred provider to POINT to lead this important study,” says Tibor Kovacs, Head of North American Operations, PSI CRO. 

POINT Biopharma is working to revolutionize radiopharmaceutical drug development and commercialization. “Choosing the right CRO partner is crucial to the success of any trial, but even more so in nuclear medicine studies,” stated POINT Biopharma’s Chief Commercial Officer, Michael Gottlieb. “PSI CRO has a proven track record of delivering radiopharmaceutical studies on time and on budget, and that means getting our product to market quickly and introducing new competitive oncology therapies to the Novartis radioligand portfolio.” 

“POINT is excited to partner with PSI CRO and launch a phase 3 registration trial of PNT2002 in prostate cancer patients,” says Joe McCann, CEO of POINT Biopharma. “This ground-breaking trial design will offer physicians and patients new options. Enrollment is expected in the fourth quarter of 2020.” 

About PSI CRO: PSI CRO is a privately-owned, full-service clinical research organization 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. 

About POINT Biopharma: POINT Biopharma is a globally focused radiopharmaceutical company with a growing portfolio of best in class pharmaceutical assets. POINT is combining a seasoned management team with strategic partnerships in radio-isotope supply, manufacturing technology and novel direct to patient targeting to revolutionize theranostic drug development and radioligand commercialization. Working closely with its scientific advisors, the Company anticipates commencement of its clinical trial programs in 2020. 

For POINT Biopharma Investor or Media Inquiries: 

Michael Gottlieb, CPA

647-268-4160 | Michael.Gottlieb@pointbiopharma.com

For Media Inquiries: 

Kayt Leonard, Public Relations Manager

919-972-9572| Kayt.Leonard@psi-cro.com

PSI CRO selected by POINT as preferred partner to lead clinical trial program Read More »

For Radiopharmaceutical Clinical Trials, Cooperation & Coordination on a Global Scale is a Must

Radiopharmaceutical therapy isn’t exactly new using radionuclides to target cancer cells via an antibody or other conjugate has been in clinical trials for well over twenty years — but it continues to challenge how clinical trials are run across borders.

Due to the complexity of regulatory requirements within each country, clinical trials in radiopharmaceuticals run the risk of becoming delayed due to a myriad of possible complications. Because progress isn’t just about advancing new therapeutic agents but also navigating through the new regulations needed for these radioactive isotopes to travel about the world.

“Using radiopharmaceuticals as treatments is the biggest change over the last few decades,” says Rhonda Critchlow, Director of Operations, Oncology at PSI CRO. “Originally the only treatment was for thyroid conditions. Now we’re seeing it for prostate cancer, treating bone metastases, some neuroendocrine tumors, with more indications to come. We’re seeing a lot more of those products that are in clinical trials or moving out to approval.”

Nuclear medicine therapy uses radiopharmaceuticals to target specific tumors by delivering radiation to cure or control the disease. It can also be used either on selective targets or throughout the entire body or even combined with immunotherapy which uses the body’s own immune system to target the disease. When monoclonal antibodies are paired with a radioactive substance they can target cancer cells and deliver high levels of radiation directly to the tumor. Zevalin® (Ibritumomab tiuxetan) was the first pharmaceutical for radio-immunotherapy commercially available worldwide. In February 2002, the U.S. Food and Drug Administration (FDA) approved it for the therapy of recurrent and resistant forms of low-grade follicular B-cell non-Hodgkin’s lymphoma.

But we’re not talking traditional drugs: we’re talking about administering a product that has a very short half-life quickly starts to decay and become inert, hampering its usefulness to the patient. Cooperation and coordination is imperative every step along the way: from the facilities and procedures where the nuclear material is produced, to their handling and storage, all the way to the transportation of the drug and dispensation. In extreme cases, sites need to be chosen due to their proximity to the manufacturing site, with transport plans & timelines showing the maximum distance between the two locations. At every stage of its life, from its creation in the cylinder (called a cyclotron), or a reactor,  to when it is given to a patient, and even beyond that, stringent regulations abound, especially on a global scale.

Many radiopharmaceuticals are now in clinical trials or moving out to approval. But timeliness defines each and every turn. Rhonda Critchlow points out, “In the US, the regulatory issues are as big as those outside of the US. But it’s true for just about any country that when it comes to these drugs; it’s all around the timing. There are always things that come up that you have to be ready for.” Anticipation is key.

Crossing Borders

When it comes to radiopharmaceuticals, regulatory is the name of the game. Stringent regulatory guidelines above and beyond the normal process have the possibility of hampering the process every step of the way. Having a CRO that understands these new regulations, not just in one country but many is imperative. Delays can occur, for example, in obtaining core submission documents. When there are queries from competent authorities those queries can take time to answer and resolve.

Having only limited experience with the regulatory process in multiple regions for clinical trials can lead to long delays. “In Europe, every country and almost every site has a different set of rules,” says John Round, Director of Business Development at PSI CRO. “That’s the added value we provide our clients simply because we’ve been involved in this area long enough, so we know what the rules are for 17 countries in Europe. There are a lot, and they’re all different.”

This is especially the case outside of the US. According to the National Center for Biotechnology Information, “in every single EU member state there is national legislation on medicinal products referring to EU directives, and in some instances, to regulations issued by the national competent authorities. Despite their shared references to the relevant EU directives, national regulations are not exactly equivalent to each other.”

Alan Morton, a Supply Chain Manager for PSI, explains that “transportation across borders needs to happen in accordance with the International Air Transport Regulations (IATA) Dangerous Goods Regulations (assuming it is being transported by air – other regulations cover surface transport).  These govern how the supplies should be packaged and labeled for transport depending on the type and activity of the material being transported.  US 49CFR Part 173 provides this direction for moving the material within the US.”

These directives are often based on jurisdictional politics and not usually on scientific evidence. This can hinder country cooperation which can lead to untimely delays and higher costs.

A good example is Germany. The Federal Office for Radiation Protection (BfS) must grant additional approval. This review can take time, almost seven months. Additionally, selected sites require specific training certificates. Plus, the manufacturing process is very different between a clinical trial vs routine practice, which means that a special manufacturing license is required for anything involving nuclear pharmacies.

The US requires approval from the Radioisotope Review committee, and that is needed before IRB submission for most sites. The sites that use Central IRBs are usually approved within 3-4 months. However, there are some that have to go through local radiation committee approval and local IRB waivers that will take 4-6 months to approve.

In Finland, an ethics committee and Regulatory Agency (Fimea) conducts reviews of studies with radiolabeled diagnostic ligands. Fimea recommends that a trial-specific calculation on radiation burden is included into submissions packages and that the radiation burden calculations are outlined in order to reduce delays.

Additional Considerations

Regulatory challenges just scratch the surface. There are even more obstacles standing in the way of running successful radiopharmaceutical clinical trials. Additional time, resources, and budget are required for applications for radiolabeling. CROs with little or no experience in radiopharmaceutical clinical trials often struggle to coordinate all these shifts in their typical mode of operation.

Only a few nuclear pharmacies can provide the needed expertise and support for such trials, including staff and facility adjustments. There are also restrictions to site locations. This is because of the instability of the radiolabeled product, if it is to be transported to a single-photon emission computerized tomography (SPECT) facility for example.

This also extends to the imaging devices used to track the isotype inside the patient. All cameras used in the radiopharmaceutical clinical trial have to be validated. There’s a whole process required to validate cameras across sites. And that needs to be done before you even start the study. Knowing that validation has to occur and making sure it occurs in a timely manner, gets documented and submitted and proofed is all part of running that trial.

Even the manufacturing of these supplies becomes a concern. “Normally supplies are packaged, released for a study, then have some time prior to being dispensed to a patient – in some cases, this can be months or years,” Alan Morton points out.  “Due to the sometimes very short half-life when shipping ‘hot’ products, it is not uncommon for radiopharmaceuticals to have the manufacturing process to be turned backward and be scheduled to meet with a specific patient visit. This means that the production, release (QP Release, if within the EU) and transport to the site need to be coordinated with absolute precision in order to meet with the date & time of the patient visit.”

Currently, each country has their own set of rules and regulations for radiopharmaceuticals. There is no uniformity at present, so understanding the granularity and variety at the country level is imperative.

An article by the Journal of Nuclear Medicine states that “extensive documentation is required for investigational submissions. Although use of the common-technical-document format has been undertaken, a harmonized format between regulatory authorities and radiopharmaceutical-specific documentation has not yet been realized. This realization is vital, because reform and standardization will streamline submission preparation and review time and potentially decrease costs. An effort as simple as harmonizing submission document names between countries would be a significant step in more effective communication between jurisdictions.”

The Next Phase

Harmonization may take time to implement — if it can even be achieved. Granted, this is nothing new in terms of regulatory requirements; however, keeping abreast of new laws and requirements that crop up daily for radiopharmaceutical therapy is the key to successful clinical trials.

The ability to safely bring this new treatment from the clinical trial side to the bedside of the patient is paramount. Creating uniformity across global borders is still a long way off. Until then, clinical research organizations must be diligent and informed about the complexities of the regulatory process for radiopharmaceuticals. Only through knowledge and cooperation will clinical trials in this therapeutic area continue to move toward timely success.

For Radiopharmaceutical Clinical Trials, Cooperation & Coordination on a Global Scale is a Must Read More »

Patient Centricity: Buzzword or Rebirth of the CRO Industry?

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.

Patient Centricity: Buzzword or Rebirth of the CRO Industry? Read More »

Tips for Managing Complex Gene Therapy Trials: Regulatory Considerations Webinar

Join Lauren Neighbours, PhD, Head Regulatory US at PSI, as she discusses the challenges and opportunities in the ever-changing regulatory landscape in the age of gene therapy.

The regulatory landscape is constantly changing, and gene therapy is no exception. Understanding what gene therapy is and current regulatory frameworks remains critical for sponsors looking to run these complex trials that come with their own set of challenges. Join Lauren Neighbours, PhD, PSI’s Head Regulatory Affairs US, as she discusses the challenges and opportunities in this growing space.

Click here for another way to view the recorded webinar.

Tips for Managing Complex Gene Therapy Trials: Regulatory Considerations Webinar Read More »

Seven Deadly Sins of Trial Supply Management: Speeding Up Enrollment? Not So Fast.

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.

Last week, we looked at the deadly sin of pride. Don’t forget – we all, always, need to learn and improve. This week, we’re diving back in and looking at our final warning sign… envy….

Envy (They’re getting the job done quicker than us, how can we stop them from making us look bad?)

For a number of reasons, there will occasionally be more than one CRO working on a study at the same time. This can sometimes cause problems behind the scenes.

PSI was recently brought on to a study to boost recruitment that was way behind schedule. However, the incumbent CRO remained in control of the drug supplies. Shortly after we got going, we were able to recruit patients far faster than the other CRO, but soon found that the drug supplies needed to treat the patients were subject to delays and stock-outs. Though this was an issue that affected the entire study, it was also a positive learning outcome for risks associated with splitting the study across two organizations.

Don’t Let The Rush Overcome The Supply

It takes significant resources –time and money- to identify a patient, screen, enroll and start treatment. It is unforgivable (as well as unethical) to allow this to happen, and then not have the supplies available to treat them when they arrive at the site.

In order to prevent this, we need to be clear with the sponsor about our expected recruitment forecasts and discuss variations – especially when recruitment is faster than expected. This will then show how much supply we will need at each point. If it becomes clear that the supplies will not be available, then we should slow recruitment rather than risk running out of drugs for ongoing patients.

Moving Ahead: Mitigation and Planning

Now that we understand the major pitfalls that can cause problems during the course of a study (remember the other 6 sins we previously discussed?), we need to understand what we can do to avoid them.  Setting milestones or checkpoints along the course of a study will help ensure that reviews are carried out in good time. Think about it: how often do even the best of the best project managers need to rely on the goodwill of others to help avoid a crisis by prioritizing work when slightly better planning and more timely decision making could have avoided the issue altogether?

The pointers below are a cyclical process, which has been used in a number of forms and is a key part of all good project management toolkits.

  • Plan Focus on the end goal and identify what we need to do to achieve that goal
  • Assess the risks Weigh the options and review the cost/benefit analysis, and mitigate against risks that can’t be avoided
  • Develop a strategy Break the plan up into milestones and work out the timelines
  • Execute Use the plan as a guide. Focus on timelines and deliverables. Be aware of risks happening and take action when they do.
  • Evaluate progress Compare real-life with the forecast. It is a lot easier to get a plan back on track if action is taken early.
  • Re-plan When life happens, update the plan with the new information
  • Communicate Make sure that when the plan changes, the relevant people know, and most importantly, know what they now need to do.

We know that mistakes are all too common in trials. And when a trial is split between two CROs, the risk of these mistakes can be even larger. It’s more important now that ever to ensure solid planning, analytical strategies, and appropriate mitigation options. Don’t let envy, and the feeling of “competing” against the other organization, ruin a well-designed study strategy.

And remember, your supplies and logistical aspects matter. As we mentioned before, running out of supplies is both unforgivable, and unethical.

Alan Morton, Trial Supply Manager

Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.

Seven Deadly Sins of Trial Supply Management: Speeding Up Enrollment? Not So Fast. Read More »

Seven Deadly Sins of Trial Supply Management: Pride Knows Best, Right?

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.

Last week, we looked at the deadly sin of wrath. Don’t forget – we’re all on the same team in the long run. This week, we’re diving back in and looking at our sixth warning sign… pride….

Pride (I know what I’m doing – how dare you question me)

It’s easy for us to fall into the same habits and trust our own expertise. But often times, our pride in knowledge and experience gets in the way of innovation, improvement, or, for better terms, lack of thinking… Let’s look at an example.

In the post-study review of an antibiotics trial, data showed that 82% of the kits produced during the study were never used. Some expired, some were damaged, some had temp excursions, and some were never sent from the central depot to the sites. The majority of the unused kits sat on the shelves at the sites at the end of the study because the number of reserves held at each site to support recruitment was too high. The clinical team insisted on having enough of the blinded drug on site to treat 3 patients concurrently. A review towards the end of recruitment of this study, however, showed that the average site only managed to recruit 1 patient every 3-4 months. Of the 900+ patients recruited, less than 30 were in treatment at the same site at the same time as another patient.

Letting Pride Get In The Way? Consider Your Risks.

Setting a study up without considering potential disruptions or complications is folly. What was once appropriate for the start of a study may not actually be appropriate as it progresses, and we have to keep that note in the forefront. Re-visiting and updating the plan with actual information is vital to ensure that the right decisions are made at the appropriate time. This could mean varying the timing or quantity of re-supply campaigns, changing the courier type, or even deciding that an in-country depot would be more appropriate than direct to site shipments.  In the previous example specifically, it means altering the buffer stock appropriately throughout all phases of the project.

Unfortunately, the stock status and levels of excess were discovered too late to reduce the site supplies to a level where it could be used by the patients remaining to be recruited. The stocking decision was based on previous experiences with other studies, rather than weighing the considerations of the current study.

And to save a lengthy explanation, it was due to the fact that pride got in the way. We all know what we’re doing, all the time, right? We’re experts. We have years of experience and have worked on dozens of studies in the same indication, right? That doesn’t mean we can fall into the habits of setting up studies the same way every single time.

Innovate, Improve, Learn

As a CRO, it’s our job to tailor every study around every aspect of the project, rather than using some sort of template to run a program. We have to ensure that we’re digging in, learning new aspects, innovating, and improving at every stage of every study. And when we’re managing trial supplies specifically, this has to be a key focus.

What’s the answer, here? Don’t let the pride of experience outweigh the benefit of consulting, learning, and improving. It’s never too late to innovate.

Next In The Series:

We’ve looked at 6 of our 7 deadly sins, and that means we’re rounding the series out next week with one that we all have to be aware of in trial supply management. Stay tuned for tips and tricks to learn about how to manage your…that’s right…envy

Alan Morton, Trial Supply Manager

Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.

Seven Deadly Sins of Trial Supply Management: Pride Knows Best, Right? Read More »

Seven Deadly Sins of Trial Supply Management: We’re All On The Same Team…

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.

Last week, we looked at the deadly sin of being lazy. Don’t forget – there’s no time to chill out and “sloth” around when a clinical trial is going on!

This week, we’re diving back in and looking at our fifth warning sign… wrath….

Wrath (That timeline is not acceptable! Put your CEO on the phone and he’ll make things happen faster!)

Ruining partnerships over unreasonable timelines? We can fix that. 

Vendors are generally open and honest about what they can achieve. In fact, we can most often trust their transparency, responsiveness, and availability. It’s a partnership, a team effort.

But when all the slack – all of the reasonable timelines and grace periods – is taken out of a project plan before it has really begun, vendors aren’t able to work through a contingency plan or catch up if there are problems in the project. If there are any errors, delays become eminent…

Can Delays Be Managed?

Delays can arise from a multitude of areas and aren’t limited to just a few ordeals. Bulk drug orders can be delivered to the packaging facility late, label text can take longer than expected to be finalized, typhoons and volcanoes can disrupt shipping lanes, customs can open supplies to inspect the contents, and the list goes on and on. And while some of these issues can be anticipated and planned for, many are unforeseeable.

Set Your Partners Up For Success

Allowing the vendor time to manage production and distribution directly correlates to the amount of time a vendor has to correctly assess and mitigate against risks. As such, vendors have a greater chance of getting the supplies where they need to be on time. With a properly built timeline, that means that sites and patients are able to receive their supplies by the actual time those supplies are needed.

Setting appropriate timelines and properly assessing risks is a huge factor in eliminating any potential “wrathful” behavior. Because every aspect of trial supply management involves multiple teams, we always need to remember the keyword: team. Because as we mentioned before, it’s a partnership. It’s a team effort.

The Final Key: Realistic Timelines

Wrath on either side of the vendor partnership is a deadly sin to fall into, and one that could ruin both the current study and potential studies. When we’re close to strict deadlines, it’s easy to overreact, demand a phone call with a boss or two, and get stuck in a wrathful mindset. But by creating realistic timelines, this behavior is immediately mitigated. Timelines are ensured, and the sites and patients – again, as noted before – are able to rely on the true timelines.

We might not be able to predict a typhoon, late deliveries, or volcanic lava sweeping through a shipping lane. But we can build a few extra days into our own project schedule on the backend, to ensure supplies are delivered by the agreed upon date from the outset. Whether it’s a CRO, sponsor, or additional vendor, the deadly sin of wrath, can indeed, become extinct.

Next In The Series

Stay tuned for the next deadly sin to avoid, and find out how a CRO can partner with vendors on behalf of sponsors to ensure trial supplies aren’t just an aspect of the project, but a successful arm of the product. Hint: next week, we’re remembering that, in fact, we don’t know everything……

Alan Morton, Trial Supply Manager

Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.

Seven Deadly Sins of Trial Supply Management: We’re All On The Same Team… Read More »