White Paper

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Using Data & Safety Monitoring Boards: From Planning to Execution

Is a DSMB right for your study?

The randomized clinical trial (RCT) is the gold standard for evaluating the benefits and harms of new medical interventions. Safety surveillance is one of the core objectives of every RCT, and one such body is a Data and Safety Monitoring Board (DSMB) – also known as a Data Monitoring Committee (DMC). 

A DSMB is an independent group of individuals with relevant expertise external to the study sponsor, charged with a periodic review of clinical trial conduct, efficacy, and participant safety and recommending trial continuation, changes, or termination when appropriate. However, the role of DSMBs has evolved since their initial creation, making their management more challenging and complicated. 

Read our new white paper to learn about: 

  • How the role of the DSMB has evolved in recent years and current challenges in DSMB management 
  • When a DSMB is needed  
  • The primary considerations for committees to maintain eligibility, credibility, and high-quality outcomes 

About Us

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

Case Study

Antibiotic development is notoriously underfunded, but PSI meets enrollment rates 23% higher than the industry average. See how PSI supported this sponsor by leveraging site relationships for the most pragmatic site selection.

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Using Data & Safety Monitoring Boards: From Planning to Execution Read More »

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Putting the Focus Back on Site Relationships in Clinical Trials

Are Your CRO’s Site Relationships Helping or Harming Your Clinical Trial?

Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints. Yet fostering deep site relationships is often overlooked because many CROs are simply unable or unwilling to put in the effort, resources, and time necessary to do so.

This task has only grown more complex in recent years. While historic challenges like staffing shortages, trial complexity, and issues related to site startup have intensified, they are now joined by the need to often learn and implement unfamiliar new technologies with little support and training.

Download our new white paper to learn about:

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

About Us

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

Case Study

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

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Putting the Focus Back on Site Relationships in Clinical Trials Read More »

pair of gloved hands drawing up medicine from a vial with a needle

Similar But Different: Regulatory and Operational Considerations for Biosimilar Clinical Development in IBD  

The rise of IBD biosimilars and what comes next

Biosimilars present untapped potential for expanding patient access and improving treatment options in Inflammatory Bowel Disease (IBD) and other therapeutic areas, but these trials also bring unique challenges and regulatory considerations.

In this white paper, you’ll learn how biosimilars have transformed the treatment landscape for IBD in the past decade, their current therapeutic uses in Crohn’s disease and ulcerative colitis, and global regulatory considerations for running biosimilar clinical trials in IBD.

Download our new white paper to learn about:

  • IBD epidemiology and current biosimilar treatment methods
  • Regulatory considerations and other challenges for biosimilar trials
  • Future opportunities for biosimilar therapeutics

Similar But Different: Regulatory and Operational Considerations for Biosimilar Clinical Development in IBD   Read More »

IBD

Inflammatory Bowel Disease: Current Status and Future Perspectives

In today’s crowded IBD clinical trial landscape, it can be difficult to complete your study as quickly and efficiently as possible. Being aware of the unique challenges that come with IBD trials can help you prepare and pivot more effectively when complications arise. In this white paper, Dr. Maxim Kosov, Senior Medical Advisor at PSI, breaks down recent trends in IBD clinical research, including insights into patient recruitment and retention.

Inflammatory Bowel Disease: Current Status and Future Perspectives offers insights into recent trial and research developments that will most impact study design and operationalization for various IBD therapies and indications. Download our new white paper to learn about:

  • IBD epidemiology, patient risk factors, and cost drivers
  • Current diagnostic and treatment methods
  • Common clinical trial challenges and methods for patient enrollment and retention

View a sneak peek below

 

Executive Summary 

Inflammatory bowel disease (IBD) is an umbrella term that covers several clinical conditions, with two of them being the most common: Ulcerative Colitis (UC), which is limited to the colonic mucosa; and Crohn’s Disease (CD), which potentially affects any segment of the gastrointestinal tract from the mouth to the anus.

Both UC and CD are chronic, lifelong inflammatory diseases with a pattern of flare-ups and remission. While we have learned a lot about the predisposing factors, clinical symptoms, pathways, pathology, and genetics, the exact cause of these diseases remains unknown. The number of clinical trials aimed at the discovery of novel therapeutic options is increasing annually. But with more trials comes increasing complexity and challenges.

As a result, while we have come a long way in developing options to treat the symptoms of the diseases, we do not yet have a definitive treatment or cure. These diseases remain highly debilitating and, while no longer fatal in industrialized countries with the current state of medicine, continue to have a negative impact on the overall quality of life for the patient. This white paper will discuss UC and CD’s respective epidemiology and risk factors, current diagnostic and treatment approaches, and considerations for designing effective clinical trials.

Discover the Latest IBD Insights in our Latest Whitepaper

ABOUT THE AUTHOR

Maxim Kosov, MD, PH.D.
PSI SENIOR MEDICAL ADVISOR

Maxim Kosov, MD, Ph.D., is a Senior Medical Advisor at PSI CRO AG (USA). He graduated from Pediatric Medical Academy in Saint-Petersburg, Russia, in 1993 and worked as an intensive care physician in neonatal intensive care units of several major hospitals. He completed an international fellowship in neonatology at Albany Medical College, NY, USA, in 1996. In parallel with clinical work, Maxim was an Assistant Professor of the Faculty of Anesthesiology and Intensive Care at Saint-Peterburg Pediatric Medical Academy.

He joined PSI in 2004 and acted as a Medical Monitor in more than 60 clinical trials in various indications. He is the author/co-author of more than 50 publications and presented his research works at numerous international meetings and congresses, including annual European Respiratory Society (ERS) meetings in Berlin (2002), Stockholm (2002), and Drug Information Association (DIA) Congress in Hamburg (2016). He is a member of ASCO.

ABOUT PSI CRO

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 based Switzerland at 113a Baarerstrasse, Zug 6300. www.psi-cro.com

Inflammatory Bowel Disease: Current Status and Future Perspectives Read More »

NSCLC Clinical Trials: History, Trends, and Opportunities

Lung cancer is one of the diseases that will never vanish from the radar of physicians, scientists, and society. However, there have been significant advances in our understanding and treatment of this disease over the past century, particularly for non-small cell lung cancer (NSCLC). In this white paper, we review the primary diagnostic and treatment options used today, the current trends, and their implications on the design and conduct of NSCLC clinical trials.

Based on PSI CRO’s experience with more than 25 Phase 2 and 3 clinical trials in advanced and metastatic NSCLC during the past ten years, we have experience overcoming several major challenges of these studies. To learn more about how we can support your upcoming NSCLC clinical trial, contact us today.

NSCLC Clinical Trials: History, Trends, and Opportunities Read More »

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

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

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

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

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

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

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