Cloudbyz

APRIL 16, 2023

However, the process of managing clinical trials is complex and time-consuming, requiring significant financial and human resources. One solution is the implementation of a unified clinical trial management platform. What is a Unified Clinical Trial Management Platform?

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pharmaphorum

SEPTEMBER 23, 2020

Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

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pharmaphorum

SEPTEMBER 2, 2020

The 3rd Lab Asset & Facility Management in Pharma will return this Winter as your ONLY industry led meeting focusing on R&D asset and FM, enabling you to regain control of your assets , optimize your space and benchmark best practices to stay ahead of the curve. What’s New in 2020? Streamed Content.

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Development Drugs 52

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. What is driving the surge in demand for APIs?

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XTalks

MARCH 20, 2024

As we approach World Water Day 2024, the theme “Water For Peace” underscores the intrinsic link between water management and conflict prevention. This initiative was born out of the need to raise awareness about water issues and encourage actions towards sustainable water management globally.

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Pharmaceutical Technology

AUGUST 17, 2022

The issue is also one that often doesn't receive appropriate attention when medical facilities consider the well being and training of their staff, with a recent academic survey suggesting that 49% of laser surgery professionals and 44% of electrosurgery professionals had never received training on the hazards of surgical smoke. "The

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pharmaphorum

AUGUST 1, 2022

This article follows part one of our two-part series, where we discussed how Philips designs innovation and digital health solutions for areas of India’s healthcare system where options are sparse. . In contrast to India, there’s not only a lack of healthcare facilities, but the facilities are not offering the services needed.

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The Pharma Data

MARCH 5, 2021

Nasdaq: BIIB) today announced its plans to build a new gene therapy manufacturing facility at its Research Triangle Park (RTP) manufacturing campuses in North Carolina to support its growing gene therapy pipeline across multiple therapeutic areas. Biogen Inc. Source link:[link].

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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XTalks

NOVEMBER 28, 2023

Amazon’s One Medical platform streamlines the process of accessing essential healthcare services, spanning from preventive care to addressing immediate health concerns and effectively managing chronic conditions such as diabetes. One Medical is designed to cater to the needs of both patients and healthcare providers.

Pharmacy 104

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pharmaphorum

JULY 25, 2022

Approximately 75% of the population resides in rural tier two and tier three cities and villages in India, and less than 20% of the country’s medical facilities are in those regions, creating an enormous imbalance and leading to immense inaccessibility for millions of rural residents. Not so much in tier two and tier three.”.

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Cloudbyz

MAY 11, 2023

This blog post will delve into the various factors that drive clinical trial costs and provide insights on how to manage and control these expenses effectively. Study Design and Complexity The design and complexity of a clinical trial are among the most significant factors that drive costs.

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Clinical Trials Clinical Trials Trials Compliance 83

Camargo

MAY 19, 2021

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation. Criteria to Obtain the Designation.

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The Pharma Data

MARCH 7, 2022

Amgen (NASDAQ:AMGN) today announced the groundbreaking of its newest biomanufacturing facility, located in Holly Springs, North Carolina. The facility, expected to be operational by 2025, will support the growing demand for Amgen’s medicines that treat serious illnesses such as cancer and heart disease.

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pharmaphorum

JANUARY 6, 2021

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer. In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years.

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pharmaphorum

JUNE 14, 2021

Accord Healthcare has introduced a new app in the UK designed to help people undergoing treatment for cancer maintain their physical and mental wellbeing. That all places an added burden on existing NHS staff, so the hope is that digital tools which can help patients manage their care could alleviate the pressure.

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Advarra

OCTOBER 31, 2023

A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study. Procedures for every process in the trial, from patient recruitment to data management, are documented in SOPs. Data management processes involve timely data entry, validation, and review.

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Pharmaceutical Technology

SEPTEMBER 1, 2022

In the pursuit of improving patient care, the continued development of POC testing can help support future demand for rapid diagnosis and treatment, with opportunities to implement successful POC facilities expanding over the years as the technology has improved.

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The Pharma Data

OCTOBER 18, 2020

In late August, Pfizer announced it was investing an additional $500 million into its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. The expanded facility is expected to add over 100 new jobs. The company’s presence in North Carolina currently exceeds 3,600 people, with 650 in Sanford.

Gene Therapy 52

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XTalks

AUGUST 11, 2023

Healthcare facilities management is a comprehensive approach to overseeing the various facets of healthcare facilities, spanning their development, maintenance, security and operations. This is achieved by synergizing facilities, assets and personnel to uphold the highest patient care standards.

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The Pharma Data

MARCH 11, 2021

management for those most in need. Without accurate diagnosis, appropriate disease management may be delayed. For people who can not easily access healthcare facilities, the ability to simplify blood collection and sample transportation on a stable device improves access to reliable diagnostics. About the Global Access Program.

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Cloudbyz

APRIL 23, 2023

The clinical trial landscape is continuously evolving, with technology playing a crucial role in streamlining processes, managing data, and improving efficiency. Centralized data management also allows for faster query resolutions, resulting in reduced data discrepancies and improved overall data quality.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

The Pharma Data

MAY 2, 2023

Starting in 2026, this facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases. The facility is designed for further expansions to accommodate future needs and new technologies. The building covers 11,500 square meters on seven floors.

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The Pharma Data

MAY 17, 2021

Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies. . Some of these activities, though mean that centers must have risk management programs in place.

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Development Gene Therapy Manufacturing Gene 52

Cloudbyz

APRIL 20, 2023

They are designed to ensure that new drugs and treatments are safe, effective, and reliable before they are made available to the public. The success of a clinical trial depends on the efficient management of the study, which is the responsibility of the sponsor. Clinical trials are an essential part of the drug development process.

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Clinical Trials Clinical Trials Trials Compliance 52

FDA Law Blog

JUNE 27, 2021

Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them. In our experience, unpreparedness can lead to confusion or misunderstandings during an inspection, and potentially cast a negative light on an otherwise compliant facility.

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Drugs Licensing Licensing Regulation 80

XTalks

DECEMBER 7, 2020

To date, most of the design emphasis for R&D centers has been centered on enabling employees to do focused individual work. Today, however, new ideas on collaboration, socialization, and even innovation are migrating from traditional corporate workplace design into the lab environment. Create a change management strategy.

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pharmaphorum

MARCH 1, 2022

Jonathan Abraham is the CEO and co-founder of Healum which provides connected software and apps to improve self-management for patients with long term conditions. He specialises in bringing digital B2B and B2Cproducts to market and has experience in business strategy and operations, sales and marketing and proposition design and development.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Bio-Techne Corporation (NASDAQ: TECH), a leading provider of proteins, antibodies and cytokines today announced that its Woburn, Massachusetts site received ISO 13485:2016 certification for Medical Device and Quality Management Systems. MINNEAPOLIS , Oct. ” About Bio-Techne Corporation (NASDAQ: TECH).

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Camargo

OCTOBER 28, 2020

Not too many facilities are located near a beach or with beautiful mountain views, so arriving at their front door at 7:30 am on a cold and snowy Montreal morning in February isn’t on the bucket list of too many people. Perhaps surprisingly, the majority of nonclinical Contract Research Organisations (CROs) are not in glamorous locations.

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Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

XTalks

OCTOBER 5, 2023

Related: Healthcare Facilities Management: 10 Industry Leaders 1. Progyny The third fastest growing healthcare company is Progyny , a leading benefits management firm that offers specialized fertility and family-building benefits for US employers. Now, let’s explore the fastest growing healthcare companies in 2023.

Pharmacy 52

Pharmacy Life Science Engineer Gene 52

The Pharma Data

APRIL 7, 2023

This investment includes a new seed dryer, state-of-the-art agricultural field equipment, storage facilities and the construction of two bomb shelters to ensure the safety of the Ukrainian colleagues who have been operating the facility and executing this investment project under very difficult circumstances. We stand with Ukraine.

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Production Life Science Branding Sales 40

Cloudbyz

NOVEMBER 3, 2021

Biosamples and biomarkers are the core basis for much of the work done in the clinical research industry and proficient Human Biosample Management (HBSM) is necessary to procure reliable biosamples. Knowing that integrating software into your Human Biosample Management structure is trending is a given. Software Integration.

Biobanking 52

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XTalks

DECEMBER 11, 2023

This personalized suspension is then delicately sprayed onto the designated treatment areas, facilitating the healing process. 7) Acutus Medical Based in California, Acutus Medical operates as a pioneering force in the field of arrhythmia management, dedicated to revolutionizing the diagnosis and treatment of cardiac arrhythmias.

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