ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

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ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

A meta-analysis of relevant studies published in scientific journals found a lack of convincing evidence that CBD – packaged as oils, vapes, creams, gummies, drinks, and more – reduces pain, prompting the team of UK […] Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

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Pharma Mirror

FEBRUARY 6, 2024

It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding. In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle.

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XTalks

SEPTEMBER 3, 2020

Over the past 13 years, James and her team have developed a package of standardized training and manuals on how to collect endpoint data. Medpace continues to work towards this continuous improvement cycle to deliver the best trials possible for their patients and research partners.

Clinical Research 98

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2024

Despite the availability of medical insurance, the penetration remains meagre with only a few people being able to access the high packages. Indian patient expenses make a strategic shift towards embedded finance access at point-of-care with options to aid out-of-pocket health expenses.

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Packaging Packaging Clinical Trials Clinical Trials 148

ACRP blog

JULY 26, 2023

That’s part of the reason why Sara Abbassi, MBBS, MSPH, a clinical research coordinator (CRC) at Wellnext LLC and ACRP member, says that educating patient advocacy groups about clinical research is a critical component of the profession. This makes sense to me,” Abbassi says.

Clinical Research 98

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Olympian Clinical Research

JUNE 27, 2023

Typically, it’s wise to avoid: Dairy products and their alternatives (cow’s milk, cheese, butter) Gluten-containing grains (wheat, barley, rye) High-sugar foods and refined carbohydrates (sugary treats, sodas, processed snacks) Processed and packaged foods with additives, preservatives, and artificial ingredients.

Clinical Research 52

Clinical Research Packaging Packaging Doctors 52

Advarra

JULY 5, 2022

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Aggregate and Individual Research Results. Reasons Supporting Return of Individual Research Results.

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Research FDA Approval Packaging Packaging 97

Advarra

DECEMBER 12, 2023

The clinical research industry, like many others, has continued to be challenged by staff turnover in recent years. Clinical research organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. Understanding this issue is essential to a healthy research organization.

Clinical Research 52

Clinical Research Clinical Trials Clinical Trials Research 52

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 12, 2023

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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Packaging Packaging Pharmacy Pharma Companies 146

Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Let’s delve into how these solutions can accelerate research and bring products to market faster.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

ACRP blog

JULY 26, 2023

That’s part of the reason why Sara Abbassi, MBBS, MSPH, a clinical research coordinator (CRC) at Wellnext LLC and ACRP member, says that educating patient advocacy groups about clinical research is a critical component of the profession. This makes sense to me,” Abbassi says.

Clinical Research 52

Clinical Research Clinical Research Coordinator Packaging Packaging 52

ACRP blog

MAY 8, 2024

Nobody ever said that clinical research would be easy. Still, panelists Seneca Harrison, Vice President of Operations and CEO of Quality Research Inc.; Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager for SiteBridge Research Inc.; We have to show up and keep on showing up.

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Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

MAY 9, 2023

In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers. If you’re considering a career in clinical research, read on to learn more about this rewarding career.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

ACRP blog

OCTOBER 11, 2022

Suzanne Rose, MS, PhD, CCRC, FACRP, executive director of research at Stamford Hospital, recently talked an employee out of retirement in part by emphasizing some of the “intangibles” making the CRC job so rewarding. No, it’s not the National Football League draft. You don’t get that when you are 100% remote,” she notes.

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ACRP blog

MARCH 6, 2024

Getting Real About Fake Companies One of the bigger recruitment agencies in the clinical research enterprise notes that it has identified dozens of fake companies. Fraudulent CRA applicants pay a fee for an overall “applicant” package.

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Imperical Blog

NOVEMBER 28, 2023

Labels are a lively commercial niche, and the global market for pharmaceutical labels… The post Clinical Trial Labeling: Don’t Get Stuck appeared first on Imperial Clinical Research Services Blog.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

MAY 27, 2022

The adoption of digital healthcare tools in clinical research accelerated dramatically during the COVID-19 pandemic and it is expected that such tools will continue to contribute to clinical research in the future. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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Clinical Trials Clinical Trials Trials Packaging 80

Olympian Clinical Research

OCTOBER 13, 2022

Be sure to follow the instructions on the package and only use the medication as directed. Consider a Clinical Research Study. If you have urticaria that does not respond to at-home treatment or over-the-counter medication, you may want to consider a clinical research study. Contact Olympian Clinical Research.

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Allergies Clinical Research Research Packaging 52

Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. Larger CROs may offer more attractive compensation packages and career advancement opportunities.

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VirTrial

DECEMBER 4, 2023

In the fast-paced world of clinical research, Randomization and Trial Supply Management (RTSM) systems play a pivotal role in ensuring the success of trials. However, a common challenge is that these systems are often one of the last to be considered in eClinical systems implementation for any particular study.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

pharmaphorum

MARCH 3, 2022

The investment package includes £200 million ($268 million) to enable researchers to better access NHS data through what the government calls Trusted Research Environments and digital clinical trial services.

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Manufacturing Life Science Clinical Trials Clinical Trials 52

Cloudbyz

JANUARY 13, 2021

. ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry. So, DCT will have a formidable impact on shaping up the clinical landscape in 2021in various aspects. Package Installation. Web Research.

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Clinical Research Trials Research Clinical Trials 52

Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

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Clinical Trials Clinical Trials Compliance Trials 66

Rethinking Clinical Trials

MARCH 1, 2023

For the investigational ramucirumab plus pembrolizumab arm, the drugs are administered per FDA package insert and institutional standard in a 21-day cycle under one of the criteria for removal is met.

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Clinical Trials Clinical Trials Trials Packaging 130

Cloudbyz

JANUARY 20, 2021

. ☰ The need for a centralized platform for clinical research study. Clinical research teams are constantly challenged to do more with fewer resources. This has led to an extreme delay in the research outcome. Package Installation. Package Installation - Sandbox. Web Research. Newsletter.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Cloudbyz

FEBRUARY 3, 2021

Opening up our doors for Clinical Research Organizations looking to streamline their existing as well as future research activities. Explore our CRO Partnership Program for uncovering new possibilities in improving your clinical trials. Package Installation. Package Installation - Sandbox. Web Research.

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Clinical Trials Clinical Trials Trials Packaging 83

pharmaphorum

JANUARY 12, 2022

Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up. We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members.

Clinical Trials 52

Clinical Trials Clinical Trials Packaging Packaging 52

Cloudbyz

DECEMBER 30, 2020

Knowing these details will allow you to choose the right CTMS for your clinical trial programs. Ease of communication and messaging: Clinical research is a team effort where often different stakeholders are located far apart. Once you created a list of vendors, it’s time to do the real research and narrow down the options.

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Clinical Trials Clinical Trials Trials Packaging 52

pharmaphorum

AUGUST 5, 2021

Theranostics combines therapeutics and diagnostics in one package for image-guided therapy and could be a step change in defining the outcome of treatment at an early stage. It also creates an opportunity for theranostics – an area of potentially significant impact – to flourish within the UK.

Medicine 52

Medicine In-Vivo Packaging Packaging 52

pharmaphorum

FEBRUARY 2, 2022

As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. When teams opted for the former option, they found themselves having to learn how to deliver decentralised clinical trials ‘on the job’. But how do we package that up?” Business as usual?

Trials 52

Trials Clinical Trials Clinical Trials Research 52

The Pharma Data

SEPTEMBER 7, 2021

“In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. The median PFS was 6.3 months (95% CI, 6.2-6.9)

HR 52

HR Packaging Packaging Trials 52

Placebo Control

MAY 23, 2017

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

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The Pharma Data

NOVEMBER 5, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

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pharmaphorum

OCTOBER 27, 2022

She advises on complex regulatory issues that arise throughout the product life cycle, including maximising regulatory protections and the overlap with IP rights, borderline classification, clinical research, authorisation, advertising and promotion, and market access strategy.

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Life Science Compliance Regulation Cosmetics 98

pharmaphorum

APRIL 11, 2022

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We Everyone is talking about using wearables in clinical trials, but to have larger market adoption you need to have the wearable data validated for clinical outcome assessment,” Dowe explains.

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