pharmaphorum

APRIL 11, 2024

It’s 2024 and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another. How did we get here? And how do we get past it?

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Clinical Trials Clinical Trials Trials 58

Cloudbyz

MARCH 22, 2024

In the realm of clinical research, the efficient management of data is paramount. However, traditional methods of data entry, particularly from diverse and unstructured documents, have long posed challenges for researchers, leading to inefficiencies, errors, and compliance risks.

Clinical Trials 77

Clinical Trials Clinical Trials Trials Compliance 77

Rethinking Clinical Trials

AUGUST 9, 2023

Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape Description Kayte Spector-Bagdady and Stephanie Morain discuss the impact of a changing policy landscape on data sharing and pragmatic clinical trials.

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Clinical Trials Clinical Trials Trials Medicine 130

ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FDA Compliance Compliance Clinical Trials Clinical Trials 52

ProRelix Research

OCTOBER 18, 2023

The increasing focus and acceptance of real-world data (RWD) in clinical decision making has led regulatory authorities and sponsors to understand its influence on data management that is an integral […] The post The Impact of Real-World Evidence on Clinical Data Management appeared first on ProRelix Research.

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Research 98

Crucial Data Soutions

APRIL 23, 2024

–(BUSINESS WIRE)–Crucial Data Solutions (CDS), a leading provider of data collection and trial management software to advance clinical research, The post Crucial Data Solutions Introduces TrialKit PACS to Streamline Image Management in Clinical Trials appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Trials Trials Clinical Research 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 107

pharmaphorum

DECEMBER 8, 2023

Pfizer’s initiative to return clinical trial data to patients Mike.Hammerton Fri, 08/12/2023 - 11:00 Bookmark this

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Clinical Trials Clinical Trials Trials 121

XTalks

NOVEMBER 1, 2023

Clinical data manager jobs involve individuals applying their expertise in healthcare and database management to analyze and report on clinical data trends. These professionals design and validate clinical databases, which may involve creating or testing logic checks.

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Scientist Life Science Clinical Trials Clinical Trials 59

Bio Pharma Dive

MARCH 28, 2022

Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.

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FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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Compliance Manufacturing Containment Regulation 105

Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access.

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Clinical Trials Clinical Trials Compliance Trials 77

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. Listen below to hear the interview.

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Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. As such, the integrity of data collected during these trials is paramount. Below, we explore some practical strategies to improve data integrity in clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 77

Rethinking Clinical Trials

JANUARY 31, 2023

Assessing Fitness-for-Use of Clinical Data for PCTs Handout A handout describing data quality checks and recommendations for assessments The post Assessing Fitness-for-Use of Clinical Data for PCTs – Training Resources Page appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials 100

ProRelix Research

OCTOBER 19, 2023

Data analytics, technology, and accessibility to the internet and healthcare has led to a paradigm shift in the way clinical trials have been conducted. Traditional clinical trials that have been […] The post Future Trends in Clinical Data Management appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

SEPTEMBER 19, 2023

Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. Traditional methods of manual data entry and study build are not only resource-intensive but also prone to human errors. Accuracy and Consistency : Human errors are a significant concern in manual data extraction.

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Compliance Clinical Trials Clinical Trials Clinical Research 93

FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. The Draft Guidance provides specific examples illustrating the application of each scenario.

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In-Vitro Regulation Marketing Clinical Trials 64

Cloudbyz

FEBRUARY 29, 2024

In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

pharmaphorum

NOVEMBER 23, 2023

The power of data science platforms to cut through the complexity of modern-day clinical research Mike.Hammerton Thu, 23/11/2023 - 09:02 Bookmark this

Clinical Research 118

Clinical Research Research 118

ProRelix Research

OCTOBER 12, 2023

Clinical trials are critical for the approval of new drugs and medical devices necessitating that data that is derived from them to make regulatory decisions is done so in a […] The post FDA’s Clinical Data Standard Requirements for Clinical Trials appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Drugs 52

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

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Clinical Development Development Clinical Trials Clinical Trials 59

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

pharmaphorum

FEBRUARY 24, 2022

The UK’s health research data capabilities are rapidly evolving. This enabled rapid recruitment to multiple COVID-19 clinical trials throughout England/UK. . In a post-pandemic world, how can we use insights gained from healthcare and research activity data to inform commercial research planning and placement decisions?

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Clinical Research Research Life Science Clinical Trials 104

Cloudbyz

JULY 19, 2023

Clinical trials are vital in advancing medical knowledge and developing new treatments. Pharmacovigilance plays a critical role in monitoring adverse events, collecting safety data, and reporting requirements to protect participants. However, ensuring participant safety is paramount throughout the trial process.

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Clinical Trials Clinical Trials Trials Compliance 85

Cloudbyz

JUNE 26, 2023

Generative artificial intelligence (AI) techniques are increasingly being applied in clinical research to enhance various aspects of medical data analysis, diagnosis, treatment planning, and drug discovery. These synthetic images can be used to augment training data, validate algorithms, and enhance image analysis tasks.

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Clinical Research Research Clinical Trials Clinical Trials 85

Cloudbyz

MARCH 13, 2023

Decentralized clinical trials (DCTs) are becoming increasingly popular as they offer many advantages over traditional clinical trials. However, managing data in DCTs can present unique challenges. What is Clinical Data Management in DCTs?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

JANUARY 17, 2024

Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years. In this pursuit, the importance of real-world data (RWD) in advancing lupus solutions cannot be overstated.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Cloudbyz

FEBRUARY 29, 2024

In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. Once the data is captured and thoroughly reviewed, it needs to be exported in a standardized format for further analysis and regulatory submissions.

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Clinical Trials Clinical Trials Compliance Trials 74

Rethinking Clinical Trials

NOVEMBER 16, 2022

Ethics, Data Sharing, Pragmatic Clinical Trials. As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance. Key Points. Two takeaways: 1.

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Clinical Trials Clinical Trials Trials Research 246

Clinical Trial Podcast

MARCH 31, 2022

There is more to the world of clinical data management than building and cleaning databases. Did you know you can leverage your clinical data for clinical operational excellence across your organization? The post Clinical Data Management with Mariam Mirgoli appeared first on Clinical Trial Podcast & Blog.

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Life Science Clinical Trials Clinical Trials Clinical Research 69

Pharmaceutical Technology

FEBRUARY 12, 2024

Vast quantities of data are only useful to researchers if that data can be easily understood and simply managed. How can AI help?

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Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

APRIL 6, 2023

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. This suggests need for investigators and health systems to consider additional ways to fulfill the ethical obligation of respecting patient-participants when sharing their data from PCTs.

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Clinical Trials Clinical Trials Trials Regulation 100

ProRelix Research

NOVEMBER 14, 2023

The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […] The post US FDA Foreign Clinical Trial Data Requirements appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Production 52