Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

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Clinical Research Research Clinical Trials Clinical Trials 98

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Clinical Research Research Clinical Trials Clinical Trials 105

XTalks

SEPTEMBER 3, 2020

Rare disease clinical trials can be particularly challenging when it comes to endpoints. Not only are there typically a limited number of patients that can be included in the trial, but often the endpoints themselves are novel or complex. Clinical Trial Endpoint Development and Quality Control in Data Collection.

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Clinical Research Clinical Trials Clinical Trials Research 98

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 188

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 188

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Clinical Trials Clinical Trials Trials Development 111

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 100

Imperical Blog

NOVEMBER 28, 2023

Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component. Did you know that product labels are big business?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

JANUARY 20, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ The need for a centralized platform for clinical research study. Clinical research teams are constantly challenged to do more with fewer resources. Resource Management.

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Clinical Research Research Clinical Trials Clinical Trials 59

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.

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Clinical Research Clinical Research Coordinator Packaging Packaging 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. Aggressive recruiters. Signing bonuses. No, it’s not the National Football League draft. It was a success story,” Rose says.

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Clinical Research Clinical Trials Clinical Trials Clinical Research Coordinator 119

Cloudbyz

JANUARY 13, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry.

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Clinical Research Trials Research Clinical Trials 52

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

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

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. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

MAY 8, 2024

Nobody ever said that clinical research would be easy. We have to be sure we are bringing the right message—delivered in the right package—[to audiences of potential trial participants]. …We We have to show up and keep on showing up. Once we have [built a] foundation of trust, so much more can happen.”

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Clinical Trials Clinical Trials Trials Clinical Research 59

Cloudbyz

AUGUST 15, 2024

Randomization and Trial Supply Management (RTSM) play a pivotal role in the successful execution of clinical trials. As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

FEBRUARY 3, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). Opening up our doors for Clinical Research Organizations looking to streamline their existing as well as future research activities. How can virtual trial ease the process?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Packaging 98

Pharmaceutical Technology

MARCH 17, 2023

According to Anguera, the field is in its infancy, particularly when it comes to testing approaches in clinical trials. But there is a difference between offering these products in parallel and as part of a single package, explains Sørensen. However, Bove notes the sector has gone through significant change in the past decade.

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Production Development Pharma Companies Marketing 278

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 93

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.

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Compliance Branding Packaging Packaging 98

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Clinical Trials Trials Compliance 40

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

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. This can lead to further delays and costs.

Clinical Research 52

Clinical Research Clinical Trials Clinical Trials Research 52

Cloudbyz

DECEMBER 30, 2020

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). Remember, a clinical trial is an evolving process, and your CTMS should be adept at accommodating your future evolving needs and not let you replace the CTMS a few years down the line. eCOA / ePRO.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

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. As part of this partnership, Formedix’s innovative all-in-one cloud-based clinical metadata repository (CMDR) and study automation platform — ryze — is being used to design CDASH-compliant eCRFs.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 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.

Manufacturing 52

Manufacturing Life Science Clinical Trials Clinical Trials 52

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. Late integration of RTSM means it inherits decisions made upstream in the trial process.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

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. Late integration of RTSM means it inherits decisions made upstream in the trial process.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

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. Late integration of RTSM means it inherits decisions made upstream in the trial process.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 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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Trials Clinical Trials Clinical Trials Research 40

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. Late integration of RTSM means it inherits decisions made upstream in the trial process.

Trials 40

Trials Clinical Trials Clinical Trials Clinical Research 40

The Pharma Data

NOVEMBER 5, 2020

About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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Trials Production Clinical Trials Clinical Trials 52

ACRP blog

JULY 1, 2024

Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”

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Clinical Trials Clinical Trials Trials Clinical Research 59

The Pharma Data

NOVEMBER 11, 2020

managing partner and director of clinical research, Sierra Eye Associates, clinical associate professor of ophthalmology, University of Nevada Presentation date and time: The pre-recorded presentation containing slides and audio will be available to AAO 2020 Virtual attendees starting on Wednesday, November 11.

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Development Antibody Production Engineer 40

ACRP blog

JULY 1, 2024

Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52