Worldwide Clinical Trials

MARCH 12, 2024

Every step in a successful oncology study requires critical and carefully thought-out decisions. Biomarkers provide a rapid way to inform many clinical oncology study development decisions, including study endpoints. What are they, how do they work, and how can they benefit your oncology study? What Are Biomarkers, and How Are They Used in Oncology?

Clinical Trials 159

Clinical Trials Clinical Trials Immune Response Trials 159

Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. One key decision is whether to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) or a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) and respective regulatory agencies of its member states.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Worldwide Clinical Trials

MARCH 1, 2024

With cost and timelines being two of the most significant factors influencing a study’s progression aside from efficacy and safety, master protocols offer an attractive option for study design. These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. But how do they work, and when are they appropriate?

Trials 171

Trials Production Development Clinical Trials 171

Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

Clinical Trials 137

Clinical Trials Clinical Trials Trials Clinical Research 137

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

Clinical Trials 177

Clinical Trials Clinical Trials Pharmacy Trials 177

Worldwide Clinical Trials

FEBRUARY 13, 2024

Get to know Rubén through this Q&A What attracted you to Worldwide, and what keeps you here? Before I joined Worldwide in June 2016, I worked at a large Contract Research Organization (CRO). In fact, my entire career as a Clinical Research Associate (CRA) was developed at large CROs, where the roles are very limited in their responsibilities, making it hard to learn anything different.

Clinical Research 130

Clinical Research Clinical Trials Clinical Trials Trials 130

Worldwide Clinical Trials

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. Many of the rare disease studies we support at Worldwide have a genetic etiology, and we discuss genetics and genetic testing with these sponsors.

Genetics 165

Genetics Trials Clinical Trials Clinical Trials 165

Worldwide Clinical Trials

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.

Trials 188

Trials Clinical Trials Clinical Trials Drugs 188

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.

Clinical Development 331

Clinical Development Clinical Trials Clinical Trials Trials 331

Worldwide Clinical Trials

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.” Among the panel participants included representatives from Teva, Blue Rock Therapeutics, and BMS.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

Worldwide Clinical Trials

NOVEMBER 27, 2023

By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.

Gene Editing 165

Gene Editing Gene Gene Therapy In-Vivo 165

Worldwide Clinical Trials

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. We recently partnered with Every Cure , a nonprofit organization, to help them advance their mission of unlocking the full potential of every existing medicine to treat as many diseases as possible — with a specific focus on rare diseases.

Clinical Trials 171

Clinical Trials Clinical Trials Clinical Development Drugs 171

Worldwide Clinical Trials

NOVEMBER 10, 2023

As someone who joined the military right after high school, I can say that it was one of the best decisions I ever made. My nearly perfect score on the Armed Services Vocational Aptitude Battery Test (ASVAB) qualified me for three positions, and I ended up taking the one that required a top-secret/SCI security clearance – as a Record Telecommunications Center Operator.

Clinical Trials 130

Clinical Trials Clinical Trials Trials 130

Worldwide Clinical Trials

NOVEMBER 10, 2023

Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar

Clinical Trials 165

Clinical Trials Clinical Trials Trials Compliance 165

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

Trials 165

Trials Clinical Trials Clinical Trials Clinical Development 165

Worldwide Clinical Trials

OCTOBER 24, 2023

In the US, a rare disease is one with 200,000 or fewer patients. Rare diseases exist in every therapeutic area and are often the more complex indications of each therapeutic area. While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.

Gene 130

Gene Gene Editing Gene Therapy Clinical Trials 130

Worldwide Clinical Trials

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.

Clinical Development 130

Clinical Development Compliance Development Trials 130

Worldwide Clinical Trials

SEPTEMBER 26, 2023

In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Worldwide Clinical Trials

SEPTEMBER 20, 2023

Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi

Clinical Trials 205

Clinical Trials Clinical Trials Trials 205

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

Worldwide Clinical Trials

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.

Clinical Development 246

Clinical Development Development Compliance Trials 246

Worldwide Clinical Trials

AUGUST 10, 2023

As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.

Clinical Trials 246

Clinical Trials Clinical Trials Trials Clinical Research 246

Worldwide Clinical Trials

MARCH 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. Through the 1990s, sponsors required a more sophisticated offering from CROs who were required to master fundamental study operations and processes, offering scalability to sponsors’ operations departments.

Development 130

Development Clinical Research Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

FEBRUARY 28, 2023

95% of rare diseases don’t have a treatment approved and won’t anytime soon. Uplifting Athletes (UA) is on a mission to change that. Back in 2010, Rob Long was a 22-year-old football player at Syracuse University on the path towards his dream career of becoming a punter in the NFL. But just a few months before his college graduation and the start of his career, Rob’s dreams fell to pieces.

Clinical Trials 130

Clinical Trials Clinical Trials Research Trials 130

Worldwide Clinical Trials

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. With so many important discussions happening this year between stakeholders, it is impossible to be a part of them all.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Worldwide Clinical Trials

FEBRUARY 6, 2023

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. At Worldwide, this topic arises frequently in discussion with rare disease sponsors.

Genetics 130

Genetics Clinical Trials Clinical Trials Genotype 130

Worldwide Clinical Trials

JANUARY 17, 2023

Ryan Gladden, our colleague and Black, Indigenous, People of Color (BIPOC) Employee Resource Group (ERG) member, shared his reflections on MLK Day. The post Reflections on Martin Luther King Jr. Day 2023 appeared first on Worldwide Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials 130

Worldwide Clinical Trials

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Worldwide Clinical Trials ​​has partnered with the leading medical genetics company, Invitae , making Worldwide ​​the first CRO to use Invitae’s Explorer tool.

Clinical Trials 130

Clinical Trials Clinical Trials Genetics Trials 130

Worldwide Clinical Trials

NOVEMBER 14, 2022

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

Trials 137

Trials Clinical Trials Clinical Trials Drugs 137

Worldwide Clinical Trials

NOVEMBER 8, 2022

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

Clinical Trials 243

Clinical Trials Clinical Trials Clinical Research Trials 243

Worldwide Clinical Trials

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. This plan, designed to help make clinical trial enrollment more representative, stands to support diversity, equity and inclusion (DEI) initiatives in R&D — a sector that certainly needs more attention across all clinical trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Drugs 130

Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now.

Trials 243

Trials Clinical Trials Clinical Trials Licensing 243

Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. Psychedelic products are having a renaissance moment. As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 billion in 2027. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

Worldwide Clinical Trials

OCTOBER 17, 2022

BioPharma Dive sat down with our Gary Fishbein for a conversation on how to de-risk trials without sacrificing cost or speed. Phase 3 oncology studies have approximately a 35% likelihood of leading to regulatory approval. There are particular challenges for oncology studies, in view of the fact that the overall likelihood of non-oncology Phase 3 studies leading to approval averages 65%.

Trials 100

Trials Clinical Trials Clinical Trials Drugs 100

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. This is because the stages differ both in scale (small vs. large) and focus (safety vs. safety and efficacy).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

Worldwide Clinical Trials

SEPTEMBER 19, 2022

Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder , substance use disorder , and post-traumatic stress disorder , has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that a

Trials 130

Trials Clinical Trials Clinical Trials Clinical Research 130

Worldwide Clinical Trials

SEPTEMBER 7, 2022

The last time I saw my mom alive, I helped her eat dinner while my son colored her a picture. We were outside, due to Covid-19 restrictions. We were lucky to finally see her in person after almost a year of daily FaceTime videos, and window visits. Of course, none of us knew it would be our last visit. She died on April 3, 2021. My mom was one of the six million Americans living with Alzheimer’s Disease.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Scientist 130