WCG Clinical

SEPTEMBER 11, 2023

When it comes to clinical trials, sponsor and provider organizations understand that sites are motivated by the science and the patients, and they recognize sites are under a tremendous strain. Sites — and patients — need a voice. This annual survey typically polls sponsors and providers. It found them.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Worldwide Clinical Trials

MARCH 7, 2024

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

OCTOBER 26, 2022

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

pharmaphorum

DECEMBER 2, 2022

This emphasises sponsors’ need for enrolment predictability. These problems are compounded with site-level concerns about protocol complexity, staffing shortages, low patient interest, and budgetary constraints — leaving sponsors to question how to plan trials that deliver against timeline commitments to support launch goals.

Trials 98

Trials Clinical Trials Clinical Trials Clinical Research 98

Worldwide Clinical Trials

DECEMBER 7, 2023

Despite a rapidly evolving clinical development landscape, we’ve remained grounded in medicine and science, helping sponsors achieve their clinical development goals across a range of therapeutic areas through our ability to adapt to changing client needs, deliver customized study teams, and dedicated scientific expertise.

Clinical Development 331

Clinical Development Clinical Trials Clinical Trials Trials 331

Worldwide Clinical Trials

FEBRUARY 26, 2024

However, Perez challenges us to rethink our longstanding assumptions of clinical operations and study design, particularly regarding the patient experience. The research provides valuable data to sponsors and researchers regarding what is most important to patients with these conditions.

Clinical Trials 137

Clinical Trials Clinical Trials Trials Clinical Research 137

WCG Clinical

OCTOBER 9, 2023

The dermatology market is embarking on tremendous growth and sponsors need to be ready. Sponsors must innovate in ways that increase endpoint predictability without adding to the burden on sites. This helps ensure sponsors and investigators have the data-driven insights to inform study design and protect clinical endpoints.

Dermatology 59

Dermatology Trials Marketing Clinical Trials 59

Worldwide Clinical Trials

JUNE 15, 2022

To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . Sites are struggling to activate — even now. . The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US.

Gene Therapy 130

Gene Therapy Gene Clinical Trials Clinical Trials 130

FDA Law Blog

MARCH 29, 2024

Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

Velocity Clinical Research

DECEMBER 6, 2023

Velocity Clinical Research, the leading multi-specialty clinical sites business, announced it has expanded into Poland, acquiring its first site, ClinMedica Research. Led by Grzegorz Kania, MD , the site has an excellent reputation for quality recruitment and exceptional patient care. and four in Germany.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

JUNE 7, 2022

By Cathy Purvis, MBA; Site Activation Manager, Oncology and Rare Disease, Worldwide Clinical Trials. This area happened to be where I was assigned when first starting in Site Activation. I began to scour clinicaltrials.gov, call sites and send off her medical records. I landed in oncology thanks to the luck of the draw.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Doctors 130

WCG Clinical

OCTOBER 6, 2023

No matter how broad the outreach or how innovative the execution, to find enrollment success, outreach strategies must connect with the personal healthcare journey of each participant, explains Tyler Bye, Director of Site Solutions and Product Strategy at WCG. Where are potential participants most likely to learn about the study?

Clinical Research 64

Clinical Research Trials Clinical Trials Clinical Trials 64

WCG Clinical

SEPTEMBER 11, 2023

Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: In episode three of WCG Talks Trials , two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report , which provides a 360-degree view on motivators and deterrents to clinical trial participation. Gina DiCindio: Sure. Gina DiCindio: Sure.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Camargo

MARCH 10, 2021

A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a manufacturing process to a larger, commercial-scale CDMO; or to replace a CDMO that has quality issues. Technology Transfer Team. Technology Transfer Documentation and Information.

Manufacturing 133

Manufacturing Production Development Compliance 133

WCG Clinical

JULY 17, 2023

Sponsors and provider organizations understand that patient- and site-centricity are critical for a robust clinical trial industry. In this two-part blog post, we’ll discuss the concerns that sites and patients have expressed and identify ways to address them. A big factor is skepticism about the pharma industry.

Research 40

Research Clinical Trials Clinical Trials Trials 40

WCG Clinical

MAY 24, 2023

The site selection and feasibility process shouldn’t be arduous, yet it continues to be a critical pain point across the clinical trial ecosystem, affecting sponsors, CROs, and investigational sites. Improving site feasibility is a complex challenge that demands a comprehensive solution. There must be a better way.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

WCG Clinical

OCTOBER 30, 2023

Sponsors, CROs, sites, and anyone else involved in running clinical trials must consider the risk of suicidality. 1] The rate is rising, especially in the US. In fact, more people died from suicide in the US in 2022 than in any year on record, according to CDC data. But deep-rooted misconceptions get in the way.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

MARCH 27, 2024

This extensive range ensures the accruement of a diverse set of samples, meeting the various needs of sponsors. Additionally, sponsors partnering with Quest Diagnostics gain access to a plethora of instruments essential for their trials. Starting with pre-contracting steps, it quickly moves to feasibility and site qualification.

Manufacturing 108

Manufacturing Clinical Trials Clinical Trials In-Vitro 108

WCG Clinical

JULY 25, 2023

This integration streamlines processes, increases data accessibility, and provides sites, sponsors, and CROs with the key information needed to improve a study’s progress. The PIC converts referrals to warm transfers that are sent to sites. For Sponsors Sponsors can access My Patient through SponsorView™.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

Clinical Trials 144

Clinical Trials Clinical Trials Trials Production 144

WCG Clinical

APRIL 20, 2023

WCG assists sponsors in achieving an appropriately diverse and inclusive patient population in their clinical trials as a trusted partner to the life sciences industry. Neva Hidajat Clinical Research Intern , Brain Inflammation Collaborative, Inc.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

DECEMBER 1, 2022

According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. The fact is, many minorities never learn about vital clinical trials in play, or that they’re eligible to participate. A new solution.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Clinical Research 110

VirTrial

JANUARY 2, 2024

Applications of AI and ML in clinical development We can’t talk about trends in clinical development without covering practical and aspirational applications for artificial intelligence and machine learning. We can’t wait to see how it helps more study teams simplify clinical trial design and management.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

WCG Clinical

JULY 17, 2023

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report , gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

VirTrial

DECEMBER 17, 2019

Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Their immobility typically prevents them from participating in traditional on-site trials. By incorporating DCTs, sponsors can be more flexible in developing protocols.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Nurses 98

Pharmaceutical Technology

DECEMBER 14, 2022

The method will utilise the Millipore Contract Testing, Development and Manufacturing Organization (CTDMO) Services facility of Merck in Carlsbad, California, US. Opened last year, this site backs the large-scale commercial and industrial production of viral and gene therapy products. Free Whitepaper.

Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

WCG Clinical

APRIL 3, 2023

Clinical research is always about the participant. Sites and sponsors must begin with one question: What makes sense for the participant? Think about the ways being part of this study will interfere with the participant’s lives. People may travel hours each way when the site is a larger medical center.

Dermatology 52

Dermatology Trials Development Clinical Trials 52

World of DTC Marketing

JANUARY 19, 2021

Just 59% of US consumers watched traditional TV on a weekly basis in 2020, compared to 83% who did so in 2017. There is no doubt that telehealth will sustain certain levels of use after the pandemic, and it could be a valuable channel to reach patients. New ways to reach consumers need to be explored.

Marketing 180

Marketing Pharma Companies Drugs Research 180

WCG Clinical

MARCH 17, 2023

With many clinical research sites facing study start-up delays and backlogs, performing a coverage analysis efficiently and thoroughly is critical to the study start-up process. But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively?

Compliance 52

Compliance Clinical Trials Clinical Trials Trials 52

WCG Clinical

MARCH 30, 2023

Clinical study protocols require the utmost attention to detail, and proper training is critical to achieving optimal performance at sites. They chose the InvestigatorSpace platform to deliver animated, on-demand training across 30 sites. Across the two studies, over 150 users at 30 sites completed the training.

Dermatology 52

Dermatology Clinical Trials Clinical Trials Trials 52

ACRP blog

FEBRUARY 14, 2024

Let us start with the good news. I especially want to highlight site personnel, who play a unique role in advancing diversity in clinical research. I especially want to highlight site personnel, who play a unique role in advancing diversity in clinical research. The issue is front and center and we are engaged—everyone.

Clinical Trials 64

Clinical Trials Clinical Trials Clinical Research Trials 64

Clinical Trial Podcast

DECEMBER 29, 2022

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

pharmaphorum

JUNE 30, 2022

Gaining insights from patient and caregiver surveys, patient advocacy groups and others can help us secure perspectives. This means designing or evaluating protocols for elements that impact enrolment, including reducing patient burden, patient-site friction, and competitive trials. Patient access. Delivery models.

Trials 63

Trials Development Drugs Clinical Trials 63

XTalks

JULY 28, 2022

July is Disability Pride Month in the US and Bristol Myers Squibb has teamed up with the non-profit Disability Solutions to improve disability diversity in clinical trials. Pablo Picasso once said, “There is only one way to look at things until someone shows us how to look at them with different eyes.”.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

Velocity Clinical Research

APRIL 19, 2023

In our January 2023 PAC meeting, Velocity asked clinical trial participants to share their ‘first impressions’ about clinical trials. Here are four lessons learned: Demystifying Clinical Trials Many participants didn’t know much about clinical research when they decided to participate.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

FEBRUARY 21, 2023

The regulatory agency may conduct the TMF inspection on-site or remotely. The inspection may include a review of the TMF documentation, as well as interviews with study staff and site visits to verify the trial’s conduct. With Cloudbyz eTMF, all clinical trial documents are easily accessible and managed efficiently.

Clinical Trials 90

Clinical Trials Clinical Trials Trials Compliance 90

Clinical Trial Podcast

OCTOBER 1, 2022

If you’re a sponsor responsible for outsourcing your clinical trials or someone who is curious about what clinical trial outsourcing entails, you’re in for a treat. Furthermore, sponsors want the best deal when it comes to outsourcing. Sponsor: This podcast is brought to you by Slope. To learn more, visit slope.io.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Outsourcing 52