Rethinking Clinical Trials

JANUARY 16, 2024

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page. Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. Learn more about AIM-CP. Learn more about the MOMs Chat & Care Study.

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Trials Clinical Trials Clinical Trials 141

Rethinking Clinical Trials

JULY 14, 2022

During the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core , moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” View slides from the discussion panel. Learn more.

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Trials Clinical Trials Clinical Trials Research 130

ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

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Clinical Trials Clinical Trials Trials Regulation 59

Cloudbyz

APRIL 9, 2024

Data Overload : Another challenge facing medical device safety operations is the sheer amount of data that needs to be analyzed. Data Overload : Another challenge facing medical device safety operations is the sheer amount of data that needs to be analyzed.

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Clinical Trials Clinical Trials Compliance Trials 67

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics Regulatory Affairs and Quality senior vice-president Christopher Shilling stated: “Forge has a shared goal with the BGTC of accelerating access to effective genetic therapies for patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.

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Rethinking Clinical Trials

DECEMBER 18, 2023

Ethics and regulatory documentation for all of the Demonstration Projects is available on our Data and Resource Sharing page. Ethics and regulatory documentation for all of the Demonstration Projects is available on our Data and Resource Sharing page. Both projects are in their planning phase.

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Clinical Trials Clinical Trials Trials 130

Scienmag

MARCH 9, 2022

As one of the pioneers in transportation research journals, open-access and peer-review journal Communications in Transportation Research (COMMTR) implements data and code closure and sharing policy to secure replication and high qualities of published articles, and to promote research resource sharing in the community of Transportation Engineering.

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Research Engineer 77

Pharmaceutical Technology

JUNE 15, 2023

Two of the biggest challenges facing healthcare R&D are the sheer volume of data and the unique characteristics of every person’s health. By analyzing vast amounts of data, AI identifies patterns that may point to the presence of diseases or the effectiveness of certain treatments.

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Pharmaceutical Technology

JUNE 27, 2022

Ipsen has signed a definitive merger agreement to acquire all the outstanding shares of commercial-stage biopharmaceutical company Epizyme, for an initial total consideration of $247m. The company will begin an all-cash tender offer through its subsidiary to buy Epizyme’s all outstanding shares for $1.45 for each share.

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FDA Approval Drugs Development 147

Pharmaceutical Technology

JUNE 15, 2023

AI can help teams collaborate and share knowledge to empower better-informed decisions. AI helps unlock meaningful questions in the exploration phase, improves predictive models using sophisticated data science techniques and can even inform product marketing. For example, MIT researchers have used AI to discover new antibiotics.

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Pharma Marketing Network

SEPTEMBER 20, 2023

Pharma companies are highly matrixed organizations, which presents challenges in handoffs, overlaps between roles and functions, access to data and accountability of who owns and acts on this data in a timely manner. Therefore, instigating change at an organizational level is difficult, and takes much longer than anticipated.

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Pharma Companies Marketing 59

Rethinking Clinical Trials

JUNE 13, 2023

Weber described recent FDA Guidance on Clinical Decision Support Software and updates to the NIH Data Management and Sharing Policy as examples of these changes, both of which were topics at the meeting. We learn so much when we’re together as investigators, but how do we share that knowledge with different groups?”

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Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. It collates and synthesizes foundational resources to create a unified, comprehensive resource.

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Clinical Trials Clinical Trials Research Trials 152

Rethinking Clinical Trials

AUGUST 7, 2023

A Safe Space for Both Failures and Successes The cochairs highlighted the importance of creating an environment where project teams can share their challenges and failures just as openly as their successes. “And we want to share those lessons learned.” ” Check said.

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Trials Clinical Trials Clinical Trials Development 130

Pharmaceutical Technology

JUNE 15, 2023

During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate. During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate.

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Clinical Trials Clinical Trials Trials Development 130

Drug Discovery World

MARCH 4, 2024

Redundant work is often necessary because assay data are poorly managed and hard to search. When it’s time to publish results or file for patents, teams are often faced with challenges in reporting key details because data are not organised in a way that facilitates querying.

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Drugs Bioassay Scientist In-Vivo 59

pharmaphorum

APRIL 14, 2021

More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . Sharing pseudonymised personal health data for public sector research, they went on, is also essential to making most effective use of limited resources. “It

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Research Regulation Genome Genomics 145

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. However, mid-size CROs may lack the regulatory expertise and resources that larger CROs possess.

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Compliance Branding Packaging Packaging 81

Rethinking Clinical Trials

OCTOBER 4, 2022

The Clinical Trial Transformation Initiative (CTTI) envisions an evidence generating system with trials that are patient-centered, integrated into health processes, quality, leverage all available data, and improve population health. We need to work together to find ways to evaluate the potential benefits and share lessons learned broadly.

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Trials Clinical Trials Clinical Trials Production 130

World of DTC Marketing

AUGUST 23, 2022

I’ve seen a lot of DTC presentations showing a correlation between reach and frequency and new Rxs, but most of that data is inaccurate. Most senior pharma people don’t have a marketing background, and agencies have been known to align data with what they want: more money. The research was straightforward.

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Branding Doctors Doctor Marketing 243

Cloudbyz

APRIL 16, 2023

However, the process of managing clinical trials is complex and time-consuming, requiring significant financial and human resources. This platform includes features such as patient recruitment, data management, regulatory compliance, and study monitoring. What is a Unified Clinical Trial Management Platform?

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Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

APRIL 8, 2024

They play a crucial role in bringing new treatments and therapies to patients, but they also come with their fair share of challenges. One of the most significant challenges in conducting clinical trials is ensuring data quality and patient safety while managing costs effectively.

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Clinical Trials Clinical Trials Trials Development 76

Rethinking Clinical Trials

JUNE 29, 2023

Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group , shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory. Harrington said it is important to share knowledge outside of the research community.

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Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

MAY 10, 2023

Participants have access to their information, data will be access broadly for research purposes, and security and privacy will be of highest importance. Participants shared that genetic information is a type of information they want to get back. All of Us has a philosophy to get data to researchers quickly.

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Medicine Research Clinical Trials Clinical Trials 130

Drug Discovery World

DECEMBER 13, 2023

The ACSR’s mission is to acquire, store, and equitably distribute biospecimens, including tissue-based pathology data, and associated clinical data from PLWH to the scientific community-at-large. Investigators have leveraged its data to drive the development of new diagnostic and treatment approaches for HIV-associated malignancies.

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Research Development Drugs 52

Cloudbyz

APRIL 19, 2023

Establishing a strong partnership can result in more efficient processes, better patient engagement, and higher-quality data, ultimately leading to improved trial performance. Establishing regular meetings, sharing updates, and using collaborative tools can help keep everyone informed and engaged.

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Clinical Trials Clinical Trials Trials Marketing 52

Drug Channels

DECEMBER 15, 2023

I couldn’t wait to share the news, hence this special Sunday post. Once again, the data demonstrate that 340B advocates are wrong when they claim that manufacturers are “stripping critical resources from the nation’s health care safety net.” For 2022, discounted purchases under the 340B program reached a record $53.7

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Pharmacy Manufacturing Drugs 80

Rethinking Clinical Trials

OCTOBER 10, 2023

Ethics and regulatory documentation for all of the Demonstration Projects is available on our Data and Resource Sharing page. Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest Demonstration Projects are now available. All of the projects are in their 1-year planning phase.

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Trials Clinical Trials Clinical Trials 141

pharmaphorum

OCTOBER 20, 2022

Together, these groups compile vast amounts of data, including rich information on patient populations, target customers, and the competitive landscape. But after months of effort, in most cases, the usefulness of this data begins and ends in a static slide deck or spreadsheet.

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Branding Marketing Production Pharma Companies 98

Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. Koopman, MD, MS Jack M. and Winifred S.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

JULY 7, 2022

Once appropriate measures have been identified, there are often challenges related to implementation of these measures and resources. and data collection methods (Should PROs be integrated within the EHR systems or in a separate repository?). and “What measures should be used to capture these outcomes?”.

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Clinical Trials Clinical Trials Trials Research 130

Cloudbyz

MAY 5, 2023

Executive Summary Risk-Based Monitoring (RBM) is an approach to clinical trial monitoring that optimizes the use of resources by focusing on trial risks, with the goal of ensuring patient safety, data quality, and regulatory compliance. Introduction 2.1. Methodology of Risk-Based Monitoring 4.1.

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Clinical Trials Clinical Trials Trials Compliance 77

Drug Channels

SEPTEMBER 24, 2023

I couldn’t wait to share the news, hence this special Sunday post. Once again, the data demonstrate that 340B advocates are wrong when they claim that manufacturers are “stripping critical resources from the nation’s health care safety net.” For 2022, discounted purchases under the 340B program reached a record $53.7

Pharmacy 69

Pharmacy Manufacturing Drugs 69

XTalks

APRIL 5, 2024

Along with the discontinuation of Relyvrio, Amylyx also announced it will be laying off 70 percent of the company’s 384 employees as a part of “restructuring to focus on the company’s financial resources on upcoming clinical milestones.” It also failed to meet any of the trial’s secondary endpoints.

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Trials Drugs Marketing FDA Approval 98

pharmaphorum

JULY 4, 2022

And this is where modern technologies and data-driven medical informatics can really bridge the gaps in rare disease research,” said Dr Joanne Hackett, head of Genomic and Precision Medicine at IQVIA, during a recent pharmaphorum webinar. Today’s rare disease landscape comprises of around 7,000 different diseases.

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Genome Genomics Research Medicine 105

Cloudbyz

APRIL 6, 2023

UCTMS provides a centralized platform for managing various aspects of the clinical trial process, including patient recruitment, scheduling, data collection, and analysis. UCTMS also helps organizations ensure compliance with regulatory guidelines and provides robust data security features.

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Clinical Trials Clinical Trials Trials Research 52

World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Putting it on the market will stress Medicare’s resources.”

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FDA Approval Drugs Doctors Doctor 239