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PSI Publishes New Report on the Future of Oncology Clinical Research

PSI CRO AG, a full-service global CRO specializing in pivotal Phase 2 and 3 trials for oncology, hematology, and other select therapeutic areas, has published a new report on the current landscape of oncology research and its impact for future trials. Preparing for the Future of Oncology Clinical Research, co-authored by PSI’s Dr. Maxim Kosov, Senior Medical Advisor, Operations, and Dr. Victor Zenzola de Toma, Medical Monitor, provides essential insights for sponsors into the trends with the greatest potential to affect clinical trial design and operationalization.

Preparing for the Future of Oncology Clinical Research cover

Kosov and Zenzola de Toma reviewed data from over 2,200 poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting to develop the comprehensive overview. Topics include:

  • General trends in oncology, including insights into concomitant medications’ impact on immune checkpoint inhibitors and emerging biomarkers such as ctDNA
  • Therapeutic advances in the most challenging indications, including “HER2-low” breast cancer and resectable stage IIIA NSCLC
  • Additional research highlights in gastrointestinal, gynecological, and genitourinary cancers as well as pediatric oncology and rare disease

“Oncology studies face unique challenges due to their expansive geographic footprints, lengthy screening and treatment durations, and massive amounts of clinical data,” said Dr. Kosov. “As the need for oncology clinical trials persists and grows, PSI CRO is committed to keeping abreast of the latest scientific advances and partnering with the companies and investigators doing the most exciting work across the wide range of oncology diseases.”

For the past 25 years, PSI CRO has worked with sponsors to advance their research in oncology by proactively cultivating long-term relationships with sites around the world and applying advanced technology for data-driven feasibility and enrollment forecast, including through its proprietary technology platform, INTELIA™.

VISIONAL™, the latest addition to the platform, allows project managers and sponsors to model and compare hundreds of country and site combinations, their budgets and probability of success within just a few minutes. In the end, it recommends the most optimal enrollment scenario in line with sponsor key objectives.

Preparing for the Future of Oncology Clinical Research is available now. For more information about how PSI plans and executes seamless oncology clinical trials with novel designs, click here.

Best Places to Work 2022: PSI CRO Honored for Fourth Year in a Row

As one of Philadelphia Business Journal’s Best Places to Work for 2022, PSI CRO has once again earned recognition for its company culture, leadership, and values as voted on by its employees. This is the fourth year in a row that PSI’s King of Prussia team has been honored with this award.

The Business Journal partnered with Quantum Workplace to identify Greater Philadelphia’s Best Places to Work. Companies are first nominated by the public, and employees at those companies are then asked to complete an online survey measuring the company culture and taking into consideration compensation, benefits, and trust in senior leadership.

Winning in this region is no small feat. King of Prussia is home to several of the top clinical research, healthcare, and biotech companies. In total, this year’s list includes 76 companies from across the region.

“The way many of us work has been fundamentally altered over the past two-plus years.” says Philadelphia Business Journal Associate Editor Lisa Dukart. “As work – and where we work – continues to evolve, one thing remains constant: Employees want to work for companies whose values and culture align with their own.”

Culture is something we take very seriously, both in King of Prussia and across the globe. PSI is privately owned by a group of managers who created it a quarter of a century ago and still come to work every day. This stability has helped nurture the global PSI culture that unites us across six continents.

Seven core values guide the way we do business:

  • Delivering Wow Service
  • Being a Teammate
  • Practicing Accountability
  • Delivering Results
  • Excelling in Communication
  • Being Excellent & Humble
  • Staying Lean

As we continue to grow each day with more than 2,600 employees around the world, these values help ensure that PSI remains on the unique path of organic growth and dedication to customer service that we’ve followed for more than 25 years. To learn about each of our values and see how you can join the growing PSI team, visit our Careers page.

PSI Named a 2022 CRO Leadership Award Champion in Three Categories

Leading full-service, global CRO continues record of success with awards in all five core categories for the fourth year in a row

PSI CRO, 14 JUNE 2022 – PSI CRO, a leading full-service, global contract research organization (CRO), has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is also the fourth year in a row in which PSI CRO received CRO Leadership Awards in all five categories, also including Expertise and Capabilities, across two respondent groups.

The CRO Leadership Awards are presented by Life Science Leader and Clinical Leader based on research conducted by ISR Reports. For 2022, 50 contract research organizations were assessed on 20+ performance metrics in five core categories in ISR’s annual CRO Quality Benchmarking survey. Winners in these categories are judged by their customers as having exceeded their expectations. Those companies that scored one standard deviation or more above the weighted average in each of the core categories are also recognized as the top performers or Champions.

“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. The data enable users of ISR’s market research to make confident business decisions based on the experiences of their industry peers.”

When the CRO Leadership Award Champion Awards were presented in 2021, PSI was named a Champion in the category of Expertise. The company has received leadership awards in the same five categories across both respective respondent groups since 2019 and also earned four awards in 2018.

“Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors,” says Nick Sinackevich, President of PSI. “Our continuing success in the CRO Leadership Awards is an important benchmark for this goal and a testament to the tireless work of our teams around the world.”

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 specializes in the planning and execution of global pivotal registration clinical trials. 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 employees, customers, investigators, and vendors. 

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

For Media Inquiries:

Ashley Stufano, Marketing Specialist

919-972-9572 |ashley.stufano@psi-cro.com

“One Huge Night” for Patients and PSI: The Gift of Life Gala

Last week, we were honored to receive the 2022 Corporate Partner Award from the Gift of Life Marrow Registry at its annual One Huge Night Los Angeles Gala at the SLS Hotel in Beverly Hills. In addition to raising funds for the organization, the Gift of Life Gala offers a chance for transplant recipients and their donors to meet in person for the first time.

At PSI CRO, we are guided by a simple, straightforward calling: every patient counts. We’re proud of our longstanding partnership with Gift of Life, a national, public, not-for-profit registry facilitating peripheral blood stem cell and bone marrow transplants for patients in the United States and abroad.

Rhonda Critchlow, PSI CRO’s Senior Director, Operations, and Jeremie Braun, Senior Director, Business Development, were in attendance to accept the award, and more importantly, to meet with the people who make the Gift of Life’s mission possible.

Jeremie was instrumental in connecting PSI to the Gift of Life organization through his involvement in the Hope4Adam campaign in 2016.

The award was presented to Jeremie and Rhonda by Jay Feinberg, Gift of Life’s founder and Chief Executive Officer as well as a 26-year transplant survivor. “It is an honor to play a small part as a corporate partner when we know we are saving lives,” said Rhonda. “PSI will remain committed to Gift of Life and the important work you are doing.  I challenge all of my friends to take up the battle – by doing something so simple as joining the registry with a cheek swab, which ultimately can turn into saving a life.”

Rhonda and Jeremie at One Huge NightAbout Gift of Life

Gift of Life is accredited by the World Marrow Donor Association and is a member of the global registry, Bone Marrow Donors Worldwide. Joining the registry is simple: it requires a mouth swab, making it simple for anyone to help save lives.

The Gift of Life headquarters in Boca Raton, Florida, has been servicing donors and patients alike since 1991. The state-of-the-art apheresis center, which opened in 2019, has made it  convenient for donors to donate stem cells in a relaxing and spa-like facility, and PSI is grateful to be able to sponsor a collection chair at the center to make donors comfortable during the process.

PSI CRO: A Proud Partner for Patients

From the beginning, PSI has worked alongside Gift of Life to gather cheek swabs at conferences like ASH and ASCO, and inspire global employees to get involved during World Marrow Donor Day, held annually on the third Saturday of each September.

But the partnership isn’t exclusive. To meet the needs of patients around the globe, raising more awareness is imperative. Corporate partners aren’t just appreciated at Gift of Life, they’re celebrated.

If your company is dedicated to patients and passionate about saving lives, you, too, can partner with Gift of Life, and help find matches for patients like Aiden, who is fighting a rare blood disorder right now.

5 IBD Clinical Development Trends to Watch From ECCO 2022

Last month, I had the honor of representing PSI CRO at the European Crohn’s and Colitis Organization (ECCO) 2022 Congress. Now in its seventeenth year, this is the biggest event for all those working at the forefront of inflammatory bowel disease (IBD) clinical research, with nearly 6,000 attendees representing more than 100 countries.

This year’s theme was “Navigating the Oceans of IBD,” focusing on what it takes to transform the latest science into practical approaches. The numerous sessions discussing novel treatments made it clear that IBD is an exciting therapy area with many new treatments on the horizon. While new therapies will offer more choice for patients and the potential for more personalized treatment in IBD, studies testing the efficacy and safety of novel combinations will be required. In addition, presenters highlighted the need for head-to-head comparative trials to help guide treatment decisions. I’ve identified five IBD clinical development trends to watch as you plan your next study.

#1: The potential of JAK inhibitors for improving the efficacy of ulcerative colitis (UC) therapy

The latest data on Janus kinase (JAK) inhibitors demonstrates that these therapies have a rapid onset of action, are associated with durable efficacy, and achieve stringent composite endpoints encompassing both endoscopic and histologic assessments with a favorable benefit-risk profile. The key to clinical efficacy for these therapies is selectivity. With a highly selective agent, we can suppress JAK1 with a higher dose while remaining below the threshold of JAK2 activation. Selectivity brings us to a different level of clinical efficacy, and greater JAK1 selectivity over JAK2 could potentially translate into a more favorable benefit-risk profile.

We started to see it with tofacitinib, a pan-JAK inhibitor. With selective JAK inhibition, we now see striking deltas in all endpoints, including rapid efficacy and superior mucosal healing. Efficacy must be balanced with safety. For example, consider the increased risk of herpes zoster related to certain JAK inhibitors. Filgotinib and upadacitinib, selective JAK1 inhibitors, show a much lower incidence of herpes zoster than tofacitinib, a JAK pan-inhibitor. However, even with selective JAK inhibitors, the incidence of herpes zoster is higher than with placebo.

As a systemic inflammatory disease, IBD can affect other organs, and more than 40% of patients with IBD have at least one extra-intestinal manifestation. Selective JAK inhibitors may also make an impact here. One study found that a 45-mg induction dose of upadacitinib resolved more extra-intestinal manifestations at eight weeks than placebo (40% versus 33%) with an even more striking difference in resolution of peripheral or axial arthropathies (55% versus 42%). Similar effects were observed in a maintenance phase.

#2: Tailoring each clinical trial to the drug’s individual safety profile

Patients’ top concerns when choosing treatment include the achievement of long-term remission; route/frequency of administration; and such safety considerations as risk of infections (particularly of herpes zoster and tuberculosis), cardiac toxicity, and lymphoma risk (the last one is most relevant to biologics and small molecules). Some of these safety concerns, such as the risk of serious infections, vaccination status prior to initiation, and liver function, are universal and relevant to all drugs. Some are drug-specific; for instance, viral reactivation and non-melanoma skin cancer for tofacitinib and filgotinib.

Certain safety-related inclusion criteria for clinical trials with small molecules should therefore be universal: pregnancy test, vaccination (including herpes zoster), infections (screening for viral hepatitis), blood test (lymphocytes, neutrophils, hemoglobin), ECG, tuberculosis screening, and skin assessment (risk of skin cancer). However, each study protocol’s design must also consider the individual safety profile of the drug.

#3: The need for additional research into long-term effects

Additional research is needed into the IBD therapies’ potential for long-term effects, such as progressive multifocal leukoencephalopathy (PML), which is associated with certain inflammatory disorders. PML is a rare, opportunistic viral infection of the brain caused by the John Cunningham virus (JCV), typically in immunocompromised individuals. The seroprevalence of JCV antibodies ranges between 35% and 90% in the adult population as a latent or persistent infection. PML is also seen in inflammatory disorders such as systemic lupus erythematosus (SLE), sarcoidosis, polymyositis, and myasthenia gravis. Most cases were seen in multiple sclerosis with natalizumab. Patients with IBD are also considered at risk and need to be monitored for PML.

#4: An increased understanding and treatment options for patients who don’t respond to anti-TNF therapies

A significant number of patients fail to respond to anti-tumor necrosis factor (anti-TNF) therapy. New data suggests that interleukin 23 (IL-23) may be a key driver of molecular resistance to anti-TNF therapy, and blocking IL-23 may restore the balance between pro- and anti-inflammatory responses in the inflamed gut. There are several treatment options for such patients, but there have been no attempts to compare efficacy of different drugs until recently.

Two studies were presented at the congress that addressed this gap. The first one compared tofacitinib with vedolizumab in adults with symptomatic UC with prior exposure to at least one anti-TNF treatment. Both groups met the primary endpoint of corticosteroid-free clinical remission at 16 weeks (45% for the tofacitinib group and 40% for the vedolizumab group); however, the endoscopic improvement at week 16 showed the superiority of tofacitinib with a 24% rate versus 7% in vedolizumab patients.

The second study compared vedolizumab to ustekinumab after at least one anti-TNF treatment failure in subjects with Crohn’s disease. The study’s main objective was to compare the short- and long-term treatment survival rates with efficacy and safety as secondary objectives. The study showed a statistically significant higher five-year survival rate with ustekinumab, with the safety profile being similar for both drugs.

#5: New approaches to defining treatment goals in both UC and Crohn’s disease studies

In all international guidelines, treatment goals include endoscopic parameters (normal mucosa or Mayo endoscopic score 0-1). Most recent clinical trials include endoscopic subscore 0-1 and both central reading and histology during initial trial. Mucosal healing can now also include histologic improvement, as seen in the ustekinumab program.

The upadacitinib program looked at the composite endpoint endoscopic-histological score and histologic remission defined as a Geboes score of less than 2.0, which means the absence of neutrophils both in the epithelium and the lamina propria. The Geboes score is a six-grade classification scoring system to assess inflammation in UC. The most stringent definition is Geboes score 0-1: no eosinophils, no neutrophils in lamina propria, no neutrophils in the epithelium, no erosion, and no ulceration. Achieving histologic remission may be correlated with improved patient outcomes: decreased risk of clinical relapse, decreased corticosteroids use, lower risk for colectomy, and lower risk of hospitalization. Increased mucosal inflammation in UC may be associated with an increased risk for colorectal cancer.

Another study compared endoscopic healing at one year with different biologics. The best endoscopic healing for ileal involvement was seen with the infliximab biosimilar (37% of patients) and the lowest rate with ustekinumab (23%) and vedolizumab (19%). In the case of colonic involvement, the lowest rate of endoscopic healing was observed with ustekinumab (29%) and vedolizumab (31%), and the highest for adalimumab (62%).

Final thoughts

As the need for clinical trials in Crohn’s disease and ulcerative colitis grows, CRO collaboration matters more than ever. At PSI CRO, we’re committed to keeping abreast of the latest scientific advances and partnering with the companies doing the most exciting work in the IBD space. Learn more about our IBD expertise here and how we can support your next study.

A Letter from PSI CRO AG to Teams Globally

Dear all,

For several days now, full-scale military aggression against Ukraine has been unfolding. There is no rhyme or reason for it, no excuse, no justification, no exoneration.

Our friends, colleagues and teammates are in bad trouble, and we are worried sick about their wellbeing. The country is under martial law.  Business operations are disrupted.

Let us now make a few specific points:

  • As of this writing, all our employees in Ukraine are accounted for and physically safe.  Emotionally, people are understandably distressed, but many have shown remarkable resilience and bravery in the face of hostilities playing out on their doorsteps.
  • Our office in Kyiv is now being used as a living quarters for those employees whose apartments are too close to the frontlines. Also, we’re lucky to have an underground garage that can be used as a shelter.
  • The leadership team in Ukraine are showing incredible resilience. Several times a night, they are awoken by the sound of air-raid sirens and they still make themselves available since the early hours of the morning, supporting their teams, alleviating other peoples’ anxiety and making sound tactical decisions. 
  • An task force consisting of the Country Managers of some of the neighboring countries (Hungary, Romania, Poland) have been working on several scenarios for resettling our employees and their families, if they need to leave the country. It looks like Poland will have to do most of the heavy lifting, for which we should be immensely grateful.
  • So far, the Internet and cellular services haven’t been disrupted, so communication hasn’t been compromised. We’re exploring various backup scenarios in case the situation deteriorates.
  • PSI drug supplies warehoused in the region are intact.
  • For obvious reasons, our ability to maintain normal operations in Ukraine is severely reduced, but, importantly, not paralyzed. Onsite monitoring is currently not possible, but our people still attend calls, file documents, write reports, stay in touch with sites and, amazingly, follow up on the status of patients whenever possible.   
  • Needless to say, the company is providing and will continue to provide support to our staff – financial, logistical, psychological. We only wish we could do more.

Many of our team members have been asking themselves, “What can I do to help?” People have offered to donate their salaries, collect warm clothes for their Ukrainian colleagues, and many other noble initiatives. This is very sweet but unnecessary. Whatever money can buy, the company will take care of that. You can do so much more. Since our operations in Ukraine have been impeded, we need to pick up the slack elsewhere. We know that work is already being redistributed within and among project teams, but we want to drive this message home:  if we all do a little more, we can reduce or even cancel out the damage. Every patient we cannot enroll in Ukraine now will have to be enrolled someplace else; every draft visit report that your teammate in Ukraine cannot review will have to be reviewed by someone else; every document that cannot be timely filed by someone in Ukraine will have to be filed by a teammate elsewhere. Every extra mile, meter, foot, inch, centimeter – counts. No extra effort is too small.

Lastly, for the sake of our collective sanity, let me offer a word of caution:  whatever you hear or read on the news or social media, do take it with a grain of salt. Every kernel of accurate information is heavily intermixed with hearsay, unsupported opinions of pseudo-experts, propaganda and deliberate fabrications.  Information can be and is weaponized – it’s the reality of contemporary warfare. Apply critical thinking – you’re good at this.

Thank you all,

PSI CRO AG

Complete Enrollment of IBD Studies on or Ahead of Time

The number of IBD trials initiated per year grows every year, meaning competition for sites and patients alike. To make sure one of our longtime clients’ IBD studies stood out, we drew on our database of more than 2,800 sites in 40+ countries to find the geo-mix that worked for them—and fast. (And they’re not our only repeat clients: about 95% of our business is repeat and referral.)

Global IBD Clinical Trials Sites

To help engage sites for an IBD study in an increasingly competitive landscape, we put together a 3-step early engagement campaign, including investigator letters, 1-to-1 calls, and webinars. Within four weeks, we’d collected 170 CDAs and 150 completed e-questionnaires from 20 countries. Building great relationships isn’t easy, but at PSI, we think it’s worth it.

Case Study Breakdown

With the combined efforts of our feasibility, site identification, and startup teams, we were able to complete enrollment two months ahead of schedule in a highly competitive indication—and with 40 more subjects randomized than planned. In today’s crowded IBD clinical trials landscape, surprise yourself. Contact us to learn how PSI CRO can deliver your next IBD trial on time.

Enrolling IBD Quickly Graph

Transition Your Ongoing Study to EU Clinical Trial Regulation in 3 Steps

After being adopted by the European Parliament in April 2014, the European Union’s Clinical Trials Regulation (Regulation (EU) No 536/2014) officially took 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 or get in touch with one of our regulatory affairs experts.

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.