Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. Deviations from the protocol can impact the study’s integrity and raise ethical concerns.

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Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gareth Powell is a business development officer for the NIHR Clinical Research Network (CRN).

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Clinical Trials Clinical Trials Trials Life Science 116

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 80

XTalks

FEBRUARY 6, 2024

Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Director of Clinical Trial Management. This revelation underscores the urgency for targeted research and clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 96

XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

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Life Science Clinical Trials Clinical Trials FDA Approval 59

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. In DCTs/HCTs, one or more components of the trial can be managed remotely from the patient’s home using wearable and remote monitoring technology. MRI scan, endoscopy, etc.)

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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

JANUARY 20, 2022

Life science consulting can be a rewarding career and the job outlook is promising for the future. . Perhaps you have heard of life science consulting jobs but do not exactly know what type of work is involved, or the education and experience needed to become a life science consultant. Job Description.

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Life Science Production Marketing Big Data 98

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical Data Pipeline for Data Review and Analyses.

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Clinical Trials Clinical Trials Trials Life Science 98

pharmaphorum

OCTOBER 1, 2020

Many companies in the life sciences industry are slow to adopt new technologies. Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. What is meant by automating clinical trials?

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Clinical Trials Clinical Trials Trials Production 111

pharmaphorum

JUNE 11, 2021

Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability.

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Clinical Trials Clinical Trials Trials Compliance 111

Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

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Life Science Clinical Trials Clinical Trials Compliance 52

Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Setting up a virtual clinical trial: Things to consider. The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 98

Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. The greater the risk, the more likely a series of trials for market clearance or approval will be required.

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Clinical Trials Clinical Trials Trials Production 52

Cloudbyz

MARCH 30, 2023

In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.

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Life Science Containment Regulation Clinical Trials 52

The Pharma Data

DECEMBER 8, 2020

Find out what 500 global clinical operations professionals had to say as they shared their experiences and opinions on the progress of modernizing clinical operations in life sciences. Increase study quality and compliance. Add bookmark. Download Your Copy. Download Your Copy.

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Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccination Vaccine 75

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors? Introduction to Salesforce. market share as of 2020H1.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors? Introduction to Salesforce. market share as of 2020H1.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

APRIL 19, 2021

Cloudbyz has positioned itself as a reputable and highly preferred CTMS solution provider in the life science domain. Post thorough analysis we realized that our client required software solutions for end-to-end guidance through post-marketing surveillance, largely into governing compliance. Solutions Delivered by Cloudbyz.

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Clinical Trials Clinical Trials Trials Life Science 52

Cloudbyz

OCTOBER 25, 2023

SPAR Solutions provides agile, innovative solutions to help clients leverage the Salesforce platform as their primary business engine The joint partnership, powered by Cloudbyz ’s Clinical Research Management Platform and SPAR Solutions, holds immense promise for the healthcare and life sciences sectors.

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Life Science Clinical Trials Clinical Trials Compliance 85

Drug Discovery World

MAY 8, 2024

The ORCA-V1 trial was led by Achieve Life Sciences, and co-led by an investigator from Massachusetts General Hospital. In their previous clinical trial, the research team found that cytisinicline helped people to quit smoking traditional cigarettes. Study drug compliance was high; 72.7% versus 15.1%

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Drugs Clinical Trials Clinical Trials Trials 72

Clinical Trial Podcast

JULY 31, 2022

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? To answer these questions and more, I invited Darshan Kulkarni to the show.

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Clinical Research Clinical Trials Clinical Trials Research 80

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Clinical Trials Clinical Trials Life Science Trials 130

The Pharma Data

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. Tiziana Life Sciences January 9, 2020 Press Release ( [link] ).

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Life Science Clinical Trials Clinical Trials Trials 40

Cloudbyz

OCTOBER 25, 2023

The joint partnership, powered by Cloudbyz ’s Clinical Research Management Platform and SPAR Solutions, holds immense promise for the healthcare and life sciences sectors. Together we aim to tackle the foremost challenges in the life sciences industry: timelines, productivity, and compliance.

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Life Science Clinical Trials Clinical Trials Compliance 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.

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Clinical Trials Clinical Trials Gene Trials 52

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Compliance Research Regulation 52

Cloudbyz

SEPTEMBER 28, 2023

In the ever-evolving world of clinical research and life-sciences, the efficient and accurate collection of data is paramount. Researchers and clinical trial professionals are constantly seeking innovative solutions to streamline the data collection process, improve data quality, and enhance overall efficiency.

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Life Science Clinical Research Clinical Trials Clinical Trials 100

XTalks

DECEMBER 4, 2023

This was because higher doses often correlated with a better reduction in tumor size, so trial designs were predicated on obtaining the maximum tolerated dose (MTD). This process is becoming increasingly complex due to the larger volume of data being collected in modern clinical trials compared to a decade ago.

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Development Drugs Clinical Trials Clinical Trials 111

Cloudbyz

MARCH 15, 2023

March 15, 2023 /PRNewswire/ — Cloudbyz, a leading provider of unified clinical trial management solutions, today announced the launch of its innovative Electronic Data Capture (EDC) product, Cloudbyz EDC 2.0. Designed to revolutionize the clinical research landscape, Cloudbyz EDC 2.0 NAPERVILLE, Ill.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program.

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Life Science Clinical Trials Clinical Trials Compliance 52

Clinical Trial Podcast

AUGUST 24, 2023

To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A.

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Clinical Research Research Gerontology Clinical Trials 40

pharmaphorum

JUNE 10, 2021

The latest version of the PRISYM 360 cloud-based labeling solution has achieved certification for the GS1 standards utilized by the medical device and life science industries. GS1 oversees a system of globally recognized open standards for unique identifiers that can be used throughout the supply chain to enhance traceability.

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Life Science Compliance Regulation Clinical Trials 52

pharmaphorum

SEPTEMBER 7, 2020

PRISYM ID makes new senior appointment to drive further growth in clinical trials arena. Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America.

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Clinical Trials Clinical Trials Sales Compliance 52

ACRP blog

APRIL 5, 2023

AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.” This has led to the emergence of a new ‘pharmaceutical intelligence’ that has allowed the industry to move away from traditional, slow-moving, and costly processes,” Lyons writes. “AI

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Big Data Clinical Trials Clinical Trials Life Science 52

XTalks

APRIL 25, 2024

Read on to learn more about the groundbreaking devices and trials shaping the future of heart failure management, as detailed by Medpace’s experts in the field. The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial.

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Development Trials Clinical Trials Clinical Trials 111

Drug Discovery World

FEBRUARY 12, 2024

We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

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Genome Genomics Life Science Gene Therapy 139