Pharma Rep Focus

Aldeyra's eye cancer hopes dashed as FDA issues rejection citing lack of clinical data

Fierce Pharma

JUNE 22, 2023

It's safe to say that a lack of clinical trials in a drug application raises red flags for the FDA. Aldeyra's bid for an approval in primary vitreoretinal lymphoma wasn't supported by clinical trial data as the company doesn't think a study in the rare and fatal disease is feasible, CEO Todd Brady, M.D.,

FDA

How to Harmonize and Interpret the Tsunami of Sensor Data in Clinical Trials

Fierce Pharma

JUNE 2, 2023

Author: Mark Matson, Managing Partner, Patient Cloud, Medidata | The surge of wearable sensors is transforming clinical trials for patients, sponsors, and research sites, but how can we optimize all the data obtained to really improve clinical trials and outcomes?

Management

Management Patients

Roots Start to Show for Hair Loss Startup Pelage With a Peek at First Clinical Data

MedCity News

FEBRUARY 28, 2024

Regenerative medicine startup Pelage Pharmaceuticals has clinical data showing its small molecule activated hair follicle stem cells. GV led a Series A round that funded the UCLA spinout’s Phase 1 clinical trial and will also support Phase 2 testing this year.

Medicine

Medicine Pharmaceutical Biopharma Pharma

Acasti, seeking to expand use of old steroid, posts clinical data on oral spray in rare disease

Fierce Pharma

JANUARY 2, 2023

Acasti, seeking to expand use of old steroid, posts clinical data on oral spray in rare disease. Tue, 01/03/2023 - 01:49.

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.

Safety

Clinical Trials Have A Data Problem. Here’s How The Industry Can Solve It.

MedCity News

JULY 27, 2023

To maximize the digital clinical trial opportunity, it is imperative to establish a solid foundation of data collection and management best practices and capitalize on the advancements in data management technologies.

Management

Management Biopharma

Clinical registry data, a valuable source of real-world data

PharmaVoice

SEPTEMBER 6, 2022

Real-world data (RWD) from clinical drug registries can and should be used throughout the drug development lifecycle. At all stages, registries ensure that assumptions about the current standard of care are accurate and evidence-based.

Framework to enable re-use of patient clinical data

European Pharmaceutical Review

NOVEMBER 28, 2022

FACILITATE , (FrAmework for ClInicaL trIal participants’ daTA reutilisation for a fully Transparent and Ethical ecosystem) is a patient-driven legal framework that intends to help return clinical trial data to study participants, ready for re-use in further research or healthcare practice.

Patients

Patients Ethics Pharmaceutical Management

Making the Most of Real-World Data in Clinical Trials

MedCity News

JANUARY 1, 2024

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.

Electronics

Electronics Media Safety Biopharma

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management.

Safety

FTC accuses data company of tracking visits to reproductive health clinics

MedCity News

SEPTEMBER 3, 2022

Kochava allegedly sold geolocation data from hundreds of millions of cell phones that showed people’s visits to reproductive health clinics, places of worship, homeless and domestic violence shelters and addiction recovery facilities. .

Should Patients Have the Right to Own Their Clinical Trial Data?

MedCity News

DECEMBER 28, 2022

Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill. It fits in amongst the goal of running nimble and patient-centered studies.

Patients

Patients Pharma Biopharma

Leveraging data to drive efficiency and patient-centricity in clinical trials

PharmaVoice

AUGUST 21, 2023

Using real-time data, patient centricity and personalized medicine to accelerate clinical trials.

Patients

Patients Medicine

The Future of MedTech: Streamlined Clinical Data Clinical Data Collection & Management

Impetus Digital

JUNE 9, 2022

Among other things, they dived into the barriers to, and benefits of, digitalization of clinical operations and trials in the MedTech industry. Here is a sneak peek of our conversation: Q: When somebody starts leveraging your platform, what are some of the modules or tools that enable them to do the data collection? Thank you, Natalie.

Management

Management Engineering Pharmaceutical Healthcare

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

Leads

Mayo Clinic, Mercy form 10-year data partnership to improve patient outcomes

MedCity News

JULY 26, 2022

Through the alliance, the two organizations are sharing their extensive clinical data with one another, which will help identify diseases and treatment plans earlier.

Patients

Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

AUGUST 3, 2022

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted.

Electronics

Electronics Healthcare Healthcare Patients

The Data Tsunami is Here—And it’s Time for “Smart” Views of Clinical Data

MedCity News

OCTOBER 25, 2023

The healthcare industry must prioritize the development and implementation of universal tools that can efficiently navigate, interpret, and derive value from the growing wealth of health data.

Healthcare

Healthcare Healthcare Physicians

Lambda and Medidata team up to automate clinical trial data

Pharmaceutical Technology

APRIL 20, 2023

Medidata, part of Dassault Systèmes, has partnered with Lambda Therapeutics to automate and consolidate data management processes for improved clinical trial efficiency. Through the tie-up, both companies aim to safely provide advanced data for faster insights.

Distribution

Distribution Management Competition Safety

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH

Pharmatutor

MARCH 26, 2022

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH. Read more about A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH Log in or register to post comments About Authors. MANISHA KOTADIYA*, JAYDEEP SAVALIYA. Ahmedabad, Email ID: jaydeepsavaliya27@gmail.com.

Management

Management Pharma

Google Cloud exec: Real-world data could eliminate the need for placebos in clinical trials

MedCity News

JUNE 22, 2022

The speed of Covid-19 vaccine trials should inspire the pharmaceutical and medical device industries to accelerate its clinical testing, according to Shweta Maniar, Google Cloud’s director for healthcare and life sciences.

Recruitment

Recruitment Healthcare Healthcare Medical

Simplify Patient-Centered Clinical Trials With Trusted Data Foundation and Machine Learning Practices

PharmaTech

SEPTEMBER 20, 2023

A common obstacle life sciences organizations face during clinical trials is obtaining the right patients and promoting consistent engagement. High-quality data and technology can be used to streamline clinical trials and enable omnichannel experiences.

Patients

Teva Pharmaceuticals-Openings for Clinical Data Management division -Apply Now

Pharma Pathway

DECEMBER 17, 2022

Teva Pharmaceuticals-Openings for Clinical Data Management division -Apply Now. We have Opportunities in our Clinical Data Management division for people who have the below mentioned exposure: Skillset – End to end CDM with Rave or Veeva exposure. Job Description. Walk-In Drive in Bangalore-. Notice Period: Any.

Management

Management Pharmaceutical Pharma

AstraZeneca’s Imfinzi tackles another type of lung cancer with latest trial win

Fierce Pharma

APRIL 5, 2024

AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive | AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance (..)

FDA

Data-Driven Connections: Linking Rare Disease Patients to Clinical Trials, Experts, and Resources

PM360

JUNE 16, 2023

Simply put, identifying a disorder and receiving a formal diagnosis is at the root of myriad difficulties—from connecting a patient to a community to generating an appropriate care and treatment plan that ideally goes beyond managing symptoms to connecting a patient to clinical trials.

Patients

Patients Healthcare Healthcare Electronics

Integrating Sensor-Generated Data to Drive Clinical Decision-Making

PharmExec

SEPTEMBER 20, 2022

Tue, Sep 20, 2022 10:00 AM EDT The seamless integration of data collected on patient behaviors and experiences is critical to improving the efficiency and effectiveness of clinical decision-making at scale in clinical research and development.

Patients

EMA pilot will see if clinical trial data should be digested ‘raw’

pharmaphorum

JULY 14, 2022

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. It may also help the regulator to define target treatment populations better.

Electronics

Electronics Medicine Prospecting Marketing

Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions (June 2023)

PharmaTech

JUNE 13, 2023

This is the final segment of this three-part PPD Tech Talk series on Improving Clinical Trials with Innovative Data Solutions featuring experts John Maier and Renay Perry of PPD®, part of Thermo Fisher Scientific.

Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions

PharmaTech

NOVEMBER 27, 2022

This is the final segment of this three-part PPD Tech Talk series on Improving Clinical Trials with Innovative Data Solutions featuring experts John Maier and Renay Perry of PPD®, part of Thermo Fisher Scientific.

Empowering Patient Healthcare Decision-Making: How Resource Sheets Support Patient Understanding of Clinical Trial Data

MedCity News

FEBRUARY 7, 2024

Providing patients with comprehensive patient resource sheets on clinical trials can alleviate worry, support dialog with family members and clinical care providers and empower informed decision-making.

Patients

Patients Healthcare Healthcare Education

Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

NOVEMBER 21, 2022

Clinical Research News’ Deb Borfitz published an article about the importance of leveraging SDOH data to improve clinical trial diversity based on an interview with Clarify Health CEO and co-founder, Jean Drouin, MD. Social Determinants Of Health Data Help Identify Sites For Trials. By Deborah Borfitz .

Food and Drug Administration

Food and Drug Administration Transportation Food Recruitment

This GSK clinical data leader embraces the ‘Rubik’s cube’ problem: solving for all sides at once

PharmaVoice

MARCH 23, 2023

The clinical data space is rapidly changing the face of the industry, GSK's Mayank Anand said — and the way organizations adopt technology is a critical part of the equation.

Establishing a Data Ecosystem Using Automation to Optimize Regulatory-Compliant Clinical Trials

PharmExec

APRIL 10, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

How AI data management can transform your clinical trial

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?

Management

Automation of Clinical Data Key in Meeting Cell and Gene Therapy Demand

PharmaTech

MARCH 29, 2024

Can Cellares deliver on the goal to meet total patient demand for cell therapies globally? CEO Fabian Gerlinghaus discusses.

Patients

Leading Clinical Trial Recruitment Strategies Center Around Real-World Data

MedCity News

JANUARY 3, 2023

By allowing study teams to design and conduct more inclusive and/or relevant studies, real-world data can enhance the standard of care and ultimately improve patient outcomes.

Recruitment

Recruitment Leads Patients Biopharma

Use Real-World Data to Optimize Design of Your Oncology Clinical Trials

PharmExec

APRIL 3, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

ESMO: In PD-1 battle GSK waged on Merck, Jemperli appears to show survival edge over Keytruda in lung cancer

Fierce Pharma

OCTOBER 19, 2023

Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor. Now, the British pharma has some new patient survival data to celebrate. Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor.

Pharma

Pharma Patients

Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

NOVEMBER 21, 2022

″ animation_offset=””] Clinical Research News’ Deb Borfitz published an article about the importance of leveraging SDOH data to improve clinical trial diversity based on an interview with Clarify Health CEO and co-founder, Jean Drouin, MD. The original article was published here on November 15, 2022.

Food and Drug Administration

Food and Drug Administration Transportation Food Recruitment

Real-World Data Networks: Automating & Reducing the Burden of Clinical Studies and Registries

PharmExec

AUGUST 7, 2022

Mon, Aug 8, 2022 1:00pm EST | 10:00am PST | 7:00pm CEST Real-world data networks are changing how data is collected and leveraged for evidence generation. A tech-enabled platform approach can significantly automate and reduce the burden of clinical study programs and registries, improve site and patient engagement and lower costs.

Networking

Networking Patients

Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia

PharmExec

APRIL 4, 2024

Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.

Patients

Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study

Fierce Pharma

MARCH 11, 2024

After a pair of approvals in recent years and as its sales continue to climb, Incyte's topical JAK inhibitor Opzelura is adding to its clinical case with trial results that demonstrate its benefits | The company presented positive data from a phase 2 study in mild-to-moderate hidradenitis suppurativa at the American Academy of Dermatology's (..)

Sales

Taming the Data Tsunami From Decentralized Clinical Trials and Real-World Data

PharmExec

OCTOBER 24, 2023

Webinar Date/Time: Tue, Nov 14, 2023 10:00 AM EST | 9:00 AM CT | 3:00 PM GMT | 4:00 PM CET

INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data

Pharmaceutical Technology

DECEMBER 19, 2023

The FDA has requested information on long-term potency after the Phase II trial was put on clinical hold due to manufacturing issues in 2022.

FDA

FDA Manufacturing

Aldeyra's eye cancer hopes dashed as FDA issues rejection citing lack of clinical data

How to Harmonize and Interpret the Tsunami of Sensor Data in Clinical Trials

Trending Sources

Roots Start to Show for Hair Loss Startup Pelage With a Peek at First Clinical Data

Acasti, seeking to expand use of old steroid, posts clinical data on oral spray in rare disease

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical Trials Have A Data Problem. Here’s How The Industry Can Solve It.

Clinical registry data, a valuable source of real-world data

Framework to enable re-use of patient clinical data

Making the Most of Real-World Data in Clinical Trials

How Machine Learning Drives Clinical Trial Efficiency

FTC accuses data company of tracking visits to reproductive health clinics

Should Patients Have the Right to Own Their Clinical Trial Data?

Leveraging data to drive efficiency and patient-centricity in clinical trials

The Future of MedTech: Streamlined Clinical Data Clinical Data Collection & Management

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Mayo Clinic, Mercy form 10-year data partnership to improve patient outcomes

Connecting EHR to clinical trials: How to embrace the promise of real-world data

The Data Tsunami is Here—And it’s Time for “Smart” Views of Clinical Data

Lambda and Medidata team up to automate clinical trial data

A REVIEW ON CLINICAL DATA MANAGEMENT : CURRENT STATUS IN CLINICAL RESEARCH

Google Cloud exec: Real-world data could eliminate the need for placebos in clinical trials

Simplify Patient-Centered Clinical Trials With Trusted Data Foundation and Machine Learning Practices

Teva Pharmaceuticals-Openings for Clinical Data Management division -Apply Now

AstraZeneca’s Imfinzi tackles another type of lung cancer with latest trial win

Data-Driven Connections: Linking Rare Disease Patients to Clinical Trials, Experts, and Resources

Integrating Sensor-Generated Data to Drive Clinical Decision-Making

EMA pilot will see if clinical trial data should be digested ‘raw’

Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions (June 2023)

Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions

Empowering Patient Healthcare Decision-Making: How Resource Sheets Support Patient Understanding of Clinical Trial Data

Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

This GSK clinical data leader embraces the ‘Rubik’s cube’ problem: solving for all sides at once

Establishing a Data Ecosystem Using Automation to Optimize Regulatory-Compliant Clinical Trials

How AI data management can transform your clinical trial

Automation of Clinical Data Key in Meeting Cell and Gene Therapy Demand

Leading Clinical Trial Recruitment Strategies Center Around Real-World Data

Use Real-World Data to Optimize Design of Your Oncology Clinical Trials

ESMO: In PD-1 battle GSK waged on Merck, Jemperli appears to show survival edge over Keytruda in lung cancer

Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Real-World Data Networks: Automating & Reducing the Burden of Clinical Studies and Registries

Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia

Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study

Taming the Data Tsunami From Decentralized Clinical Trials and Real-World Data

INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data

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