Pharmaceutical Technology

APRIL 14, 2023

Both libraries feature up to 10,000 gene fragment combinations, and allow the high-throughput screening and characterisation of new and known sequence variants to develop therapeutic solutions.

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Development Gene Therapy Gene Antibody 246

WCG Clinical

JUNE 28, 2023

Princeton, NJ, June 28, 2023 — WCG, one of the world’s leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials.

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Clinical Trials Clinical Trials Trials Radiology 97

Pharmaceutical Technology

MAY 26, 2023

This achievement really motivates us to keep pushing boundaries and coming up with innovative solutions.” Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.

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Gene Therapy Gene FDA Approval Manufacturing 264

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients.

Gene Therapy 130

Gene Therapy Gene Development Antibody 130

Rethinking Clinical Trials

OCTOBER 31, 2023

This talk describes the PaxLC Trial’s strategies to implement a digital, decentralized, and democratized approaches to multidisciplinary research that address the deficiencies of traditional research studies, which can tend to be hierarchical, siloed, slow, expensive, and inconvenient. We had to come up with solutions.

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ACRP blog

AUGUST 2, 2023

To better understand the current site landscape and the top challenges sites are facing, WCG created the 2023 Clinical Research Site Challenges Survey Report , in addition to recommendations for sites, sponsors, and contract research organizations (CROs) to better address study needs and the needs of the sites conducting those studies.

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Trials Clinical Research Clinical Trials Clinical Trials 52

ACRP blog

AUGUST 2, 2023

To better understand the current site landscape and the top challenges sites are facing, WCG created the 2023 Clinical Research Site Challenges Survey Report , in addition to recommendations for sites, sponsors, and contract research organizations (CROs) to better address study needs and the needs of the sites conducting those studies.

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Trials Clinical Research Clinical Trials Clinical Trials 52

Rethinking Clinical Trials

DECEMBER 12, 2023

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials.

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Pharmaceutical Technology

JUNE 1, 2023

It will focus on studying and developing new lipid nanoparticle (LNP) formulations for the delivery of RNA medicine. The new centre will serve as a platform to find solutions to these challenges. The funding is being provided under the agency’s Transforming Medicines Manufacturing programme.

Drug Delivery 242

Drug Delivery RNA Development Drugs 242

VirTrial

OCTOBER 6, 2023

Digital health technology (DHT) solutions are now widely adopted and applied in today’s clinical trials. At Signant, to ensure that our solutions are fit-for-purpose in terms of patient and site usability, we routinely engage with sponsors, sites, and potential or current trial participants in qualitative research.

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Clinical Trials Clinical Trials Trials Research 52

Pharmaceutical Technology

APRIL 3, 2023

The development pipeline of such therapies has been growing strongly and more and more are reaching major milestones,” said René Fáber, member of the executive board and head of the bioprocess solutions division of Sartorius, in a statement.

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Gene Therapy Gene DNA Reagent 246

Cloudbyz

FEBRUARY 21, 2023

The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, monitoring reports and others. The agency may also review the TMF to assess the quality of the trial’s data and the validity of the trial’s results.

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Clinical Trials Clinical Trials Trials Compliance 94

ACRP blog

AUGUST 9, 2023

In the forthcoming August issue of ACRP’s Clinical Researcher journal , these and other findings are detailed in a peer-reviewed article on “Perspectives from Principal Investigators on Improving Diversity Among Clinical Research Participants” by Nadine H. Spring, PhD, CCRC, Jeanne Connors, PhD, Michael Schwab, PhD, and David O.

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Trials Clinical Trials Clinical Trials Clinical Research 98

WCG Clinical

MAY 9, 2023

Finally, through WCG Data Intelligence, the company provides deep insights into the competitive landscape of the protocol being reviewed that can be leveraged for site selection. Making the investment in a protocol optimization solution like this is key to conducting faster, higher-quality clinical trials.” Princeton, N.J. –

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Clinical Trials Clinical Trials Clinical Research Trials 52

Camargo

OCTOBER 28, 2020

However, the experienced nonclinical scientist understands that no matter the duration, scope, or objectives of a study, monitoring visits are a critical part of any nonclinical (or preclinical) program. Nonclinical Study Preparation. Nonclinical Study Initiation.

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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. Katrina Rice is an accomplished Chief Delivery Officer at eClinical Solutions.

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Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

SEPTEMBER 14, 2023

Cloudbyz, a leading EDC solution built on the Salesforce platform, has taken a significant step towards bridging this gap, offering a comprehensive suite of tools to enhance the efficiency and effectiveness of clinical trials. This eliminates the need for manual data entry and reduces the risk of transcription errors.

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Clinical Trials Clinical Trials Clinical Research Trials 81

VirTrial

OCTOBER 3, 2023

Webinar Takeaways Our speakers agreed AI can provide a solid foundation for data aggregation, which can be helpful in several stages of a study. It can help us flag for additional reviews, subjects who may be questionable and then help sponsor decide whether this such a subject should participate in the trial or potentially not.

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Trials Clinical Trials Clinical Trials Production 52

Pharmaceutical Technology

MARCH 8, 2023

Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies. This Beacon’s focus will be on product solutions that help address the bottlenecks impacting manufacturing yield and quality of cell therapies.

Gene Therapy 244

Gene Therapy Manufacturing Gene Production 244

Cloudbyz

AUGUST 17, 2020

Here are some of the hot features that most organizations are currently looking for in their eConsent solution: User Friendly. A secure eConsent solution is one that provides multiple layers of authentication, whether it be in the form of an OTP or an email verification. Knowledge review. Authentication. Query handling.

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Clinical Research Licensing Licensing Containment 98

Pharmaceutical Technology

APRIL 4, 2023

Gennova Biopharmaceuticals CEO Sanjay Singh said: “We are seeing encouraging results with precise intradermal delivery of our vaccine using the PharmaJet Tropis needle-free solution.

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Gene Therapy Vaccination Vaccine Gene 147

Cloudbyz

MARCH 15, 2023

Building an electronic data capture (EDC) system for a clinical study involves several steps that must be carefully planned and executed to ensure data accuracy, completeness, and security. Choose an EDC system: Select an EDC system that meets the requirements of the study and that is compliant with regulatory standards.

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Compliance Clinical Research Research 52

Trialfacts

NOVEMBER 12, 2023

Contents About the Study Why Participate? More Study Details About the Research Center: Location Research Center: Sonova USA, Inc. That’s why this study is testing investigational hearing devices, to find ways for improvement. The information gained in this study may improve hearing aid technology for future users.

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Branding Research Licensing Licensing 52

Pharmaceutical Technology

AUGUST 10, 2022

According to Jayna Blake, at Baxter BioPharma Solutions (BPS), the need for demonstrable performance and expertise from an established CMO should be at the top of any sponsor’s list of requirements. Reviewing proposals???. The result is greater flexibility - an advantage in an industry prone to unforeseeable disruption and shortages.?.

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Contract Manufacturing Manufacturing Production Packaging 130

Rethinking Clinical Trials

FEBRUARY 28, 2024

In a remote study, it would be possible for duplicate enrollment, falsified or fabricated eligibility source documents, or data completed by surrogates. Getting study drug and other study materials into the hands of a participant requires distribution via mail or courier, breaking the traditional chain of custody.

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Clinical Trials Clinical Trials Trials Clinical Research 141

Cloudbyz

FEBRUARY 26, 2023

The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports.

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Clinical Trials Clinical Trials Compliance Trials 89

VirTrial

JANUARY 2, 2024

They also often rely on CROs to recommend eClinical solutions that can help meet critical milestones on time. We can’t wait to see how it helps more study teams simplify clinical trial design and management. Emerging biopharma can utilize our Unified Platform for any trial and any phase.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Trialfacts

OCTOBER 23, 2023

Contents About the Study Why Participate? Ulrich Kirk IRB: This study has been reviewed and approved by the Virginia Tech Institutional Review Board About the Study Sleep troubles keeping you up at night? That being said, the need for a safe and effective solution is more critical than ever. Interested?

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Research Branding Scientist 52

WCG Clinical

AUGUST 7, 2023

It continues throughout the entire study. The goal isn’t merely to enroll patients, it’s to successfully complete the study. To that end, we’re going to identify ways sponsors and CROs can help sites optimize enrollment capacity and improve overall study enrollment and retention. Take chart review as an example.

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Clinical Trials Clinical Trials Trials 52

WCG Clinical

JANUARY 12, 2024

Study team capacity: Multitasking is a myth Effective recruitment, screening, and retention require a consistent and focused approach. The skill to interact with people and connect are not the same skills needed to review data for completeness. Sites, dealing with a wide range of studies, must adapt to various technologies.

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Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JANUARY 9, 2024

Moreover, users in the life sciences sector at Atropos Health can now conduct comprehensive real-world evidence (RWE) studies by using the extensive longitudinal research dataset offered by Arcadia within the Atropos Evidence Network. This helps to determine the efficacy of specific study designs within various subpopulations.

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Life Science Clinical Trials Clinical Trials Trials 59

WCG Clinical

APRIL 28, 2023

In this webinar, our experts will review challenges and scenarios that clinical research billing teams regularly navigate, and discuss key considerations for the coverage analysis and budgeting processes to ensure your billing teams are set up for success. Click here to learn more.

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Research Clinical Trials Clinical Trials Clinical Research 52

Imperical Blog

MARCH 8, 2021

After a study closes, retention requirements are minimally two years but often exceed 15-30 years. Alternatively, the study files can be moved to an outside storage facility. However, many studies still use paper CRFs and regulatory documents or a mix of paper and electronic data, necessitating costly, inconvenient archiving.

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Trials Regulation Research 52

Drug Discovery World

JUNE 14, 2023

The study of health and disease through multi-omics research generates vast amounts of interconnected data. To this end, Evotec has developed PanHunter, a platform that combines peer-reviewed statistical analysis algorithms with the potential of machine learning and artificial intelligence.

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Bioinformatics Research Development Drugs 52

World of DTC Marketing

MARCH 6, 2022

A 2016 study reported that 259,000 digital health apps were available for consumers. Global consumers will spend $49 billion by 2020 on digital health solutions. Maybe, however, they should check with patients first. billion that year and approached $6 billion the following year. Heath Affairs.

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Production Doctors Doctor Branding 244

Pharma Marketing Network

JULY 25, 2023

Explore online directories, review websites, and social media platforms to gather a list of agencies with positive reviews and a strong online presence. Request case studies or references to gain insights into their past projects and success stories.

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Marketing Engineer Branding Research 98

ACRP blog

OCTOBER 24, 2023

While feedback from clinical trial participants that they would like their personal study data and overall trial results to be shared with them has been loud and clear for many years now , effective follow-through from sponsors and sites on such sentiments has historically been more muddled. Among the nonprofit TransCelerate BioPharma Inc.’s

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