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.

Life Science 52

Life Science Containment Regulation Clinical Trials 52

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.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

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. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 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?

Clinical Trials 111

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.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Compliance 111

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 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.

Clinical Research 52

Clinical Research Compliance Research Regulation 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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Packaging 98

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.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 130

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.

Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. 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.

Genome 139

Genome Genomics Life Science Gene Therapy 139

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.

Life Science 52

Life Science Compliance Regulation Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Billion by 2025.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

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. About PRISYM ID. Media Contact: Andrew Baud, Distil,?

Life Science 52

Life Science Clinical Trials Clinical Trials 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

Big Data 52

Big Data Clinical Trials Clinical Trials Life Science 52

pharmaphorum

OCTOBER 5, 2020

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions . . regulated content and label management?solutions, The post PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team appeared first on. Wokingham, United Kingdom —?30?September?2020?—

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.

Development 96

Development Regulation Production Life Science 96

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.

Clinical Trials 52

Clinical Trials Clinical Trials Sales Compliance 52

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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Cloudbyz

APRIL 6, 2023

Naperville, Illinois – April 6, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with Odaseva, the leading Enterprise Data Protection Platform built specifically to address the needs of the largest Salesforce customers.

Life Science 52

Life Science Compliance Clinical Research Clinical Trials 52

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

Regulation 59

Regulation Sales Clinical Trials Clinical Trials 59

XTalks

DECEMBER 4, 2023

Matthew Confeld, PharmD, PhD Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials In this Xtalks Spotlight edition, Xtalks spoke with Matthew Confeld, PharmD, PhD, Assistant Director of Clinical Research Methodology at Worldwide Clinical Trials , about Project Optimus and what it means for oncology programs.

Development 111

Development Drugs Clinical Trials Clinical Trials 111

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

pharmaphorum

DECEMBER 7, 2020

Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life sciences sector, announced today that PRISYM 360 version 1.10 has achieved SAP® certification using SAP Cloud Platform Integration Suite. – Ends – About PRISYM ID.

Life Science 52

Life Science Compliance Clinical Trials Clinical Trials 52

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

Life Science 52

Life Science Clinical Trials Clinical Trials Regulation 52

XTalks

MARCH 13, 2024

Related: Transforming Eye Care: Innovating New Glaucoma and Dry Eye Disease Treatments — Featuring Pierre Simon, VP Marketing, Sight Sciences – Xtalks Life Science Podcast Ep. Secondly, other funded research is exploring differential gene expression regulated by DNA methylation.

Gene Therapy 111

Gene Therapy Gene Life Science DNA 111

XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

Development 111

Development Trials Clinical Trials Clinical Trials 111

XTalks

FEBRUARY 22, 2022

A successful life science webinar engages the audience in a unique manner, drives the right kind of traffic and provides genuine value for attendees. Here are 5 trending life science webinar topics that have been resonating well with our audiences. Decentralized Clinical Trials, Hybrid Trials & Virtual Trials .

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

Pharma in Brief

AUGUST 23, 2022

The Federal Court of Appeal ( FCA ) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), confirming the Federal Court ( FC ) holding that claims to uses of the molecule fampridine were invalid. In response, Biogen asserted Canadian Patent No.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

Pharma Business Blog

NOVEMBER 24, 2022

This news will impact all the companies that are doing clinical trials in Europe. EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. Dr. Sandra Ragaz , Partner Leader Pharma & Life Science VAT Switzerland +41 79 792 72 98 sandra.ragaz@pwc.ch.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

XTalks

JUNE 12, 2023

The manufacturing process for cell therapies, like autologous T cell therapy, is complex and labor-intensive, involving numerous procedures that can affect regulatory compliance and consistency. Each batch of engineered T cells is manufactured individually and subsequently infused back into the original patient.

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. COVID-19 has demonstrated that trials can be run much more efficiently, to everyone’s benefit. Compliance is key.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Safety will create a single source of truth for content management.

Life Science 110

Life Science Development Research Production 110