XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. In the same webinar, Dr. Hansie M. percent), Black (12.6

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pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. clinical trial diversity. clinical trial diversity.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Drug Discovery World

DECEMBER 27, 2023

In Conversation With In the In Conversation With series, Thomas speaks with members of the drug discovery industry about their work and how it helps turn science into business. Walz shared insight into how real world data can help to boost diversity rates in clinical trials. DDW Highlights Innovative. Developing. Listen here.

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Drug Discovery World

DECEMBER 8, 2023

The current state of vertical AI integration in cell and gene therapy development Vertical AI was born out of the need to integrate AI systems that would convert its extensive data and expertise into meaningful outputs that deliver targeted solutions to specific customer problems.

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Cloudbyz

APRIL 11, 2023

The E2B gateway must ensure the confidentiality, integrity, and availability of the data being transmitted. Integration Finally, the E2B gateway is designed to integrate with other pharmacovigilance systems. Integration Finally, the E2B gateway is designed to integrate with other pharmacovigilance systems.

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ACRP blog

AUGUST 2, 2023

Clinical research is an integral part of improving patient care and advancing medical knowledge, but over the last several years, clinical trials have continued to become increasingly complex. Additionally, enrollment in existing and new clinical trials remains closely tied to site resourcing levels.

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ACRP blog

AUGUST 2, 2023

Clinical research is an integral part of improving patient care and advancing medical knowledge, but over the last several years, clinical trials have continued to become increasingly complex. Additionally, enrollment in existing and new clinical trials remains closely tied to site resourcing levels.

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XTalks

NOVEMBER 27, 2023

This dynamic landscape is marked by the integration of patient-centric approaches, real-world evidence and cutting-edge technologies. Dhingra also has experience in regulatory intelligence, medical information, pharmacy benefit management, quality management systems, training, compliance, clinical and retail pharmacy.

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Cloudbyz

APRIL 16, 2021

Being a large company, our client (a CRO) struggled to effectively manage several clinical trial sites and collaborate (in terms of data visibility, approvals, and performance mapping) efficiently with all the stakeholders involved. Company Information. Constraints Faced by the Client.

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Cloudbyz

MARCH 16, 2023

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring patient safety, and it is an essential component of drug development and regulatory compliance.

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Drug Discovery World

DECEMBER 6, 2022

1 Vaccine development was conducted at great pace and within a year of the first infection being reported, the first Covid-19 vaccine to report phase III clinical trial data demonstrated unexpectedly high efficacy and cleared regulatory efficacy criteria with ease. Quasi-experimental and other randomised trial designs .

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Worldwide Clinical Trials

JUNE 15, 2022

At the same time, they must also work together with industry to ensure that the path we follow gives patients the data transparency and ownership they so urgently crave. We must move forward thoughtfully, with the same rigor expected in clinical trials. consent forms) to digital ones. That’s where blockchain may prove helpful.

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Drug Discovery World

JANUARY 31, 2023

Robust digital workflows can reduce errors and time to compile data leading to greater transparency, faster reporting and help biopharmaceutical companies reach regulatory submission faster. The lack of common context, for both approaches, creates data integrity challenges which in turn can put successful filing at risk.

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The Pharma Data

AUGUST 31, 2020

The African Union through the AMSP has integrated vetted medical suppliers to ensure rapid access to affordable COVID-19 related supplies. The African Union through the AMSP has integrated vetted medical suppliers to ensure rapid access to affordable COVID-19 related supplies.

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Rethinking Clinical Trials

APRIL 13, 2023

They are intended to remind, guide, or motivate a decision, and they should be transparent. It works to improve health care value and outcomes, advance the science of designing interventions to change behavior and evaluate and disseminate the impact of interventions.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. Karen holds a PhD in Natural Sciences from ETH Zurich, and an MBA from IMD, both in Switzerland.

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pharmaphorum

JUNE 29, 2021

Robert Galarza outlines how blockchain technology can be utilised to verify, validate and standardise the efficacy of medical cannabis and other plant based therapies in clinical trials. . Thus a blockchain can track anything from the sale and ownership of a few dogecoins to the entire life cycle of a sensitive clinical trial.

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WCG Clinical

JULY 17, 2023

Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report , gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency.

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The Pharma Data

AUGUST 30, 2021

Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. ABC treated with ribociblib + ET in the ML-3 ML-7 trials [Kisqali; Abstract presentation # 233P; poster available: Monday, Sept.

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The Pharma Data

DECEMBER 18, 2020

“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.

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The Pharma Data

APRIL 28, 2021

Initial agreement covers reservation of the large-scale state-of-the-art biologics facility in Singapore site for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®. Follows recent initial agreements for providing manufacturing capacity for CureVac and BioNtech .

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The Pharma Data

APRIL 28, 2021

These data, to be presented at the American Academy of Neurology (AAN) Annual Meeting being held virtually on April 17-22, 2021, further support Kesimpta as a first-choice treatment option for adults with RMS. Evidence shows that progression occurs in people living with MS in the early stages of disease.

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Drug Discovery World

FEBRUARY 20, 2024

Industry experts explain how blockchain can fundamentally enhance clinical trials. Obtaining consent from patients or healthy volunteers is a fundamental requirement for enrolling participants on to clinical trials. Informed consent in the future.

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Drug Discovery World

FEBRUARY 20, 2024

Industry experts explain how blockchain can fundamentally enhance clinical trials. Obtaining consent from patients or healthy volunteers is a fundamental requirement for enrolling participants on to clinical trials.

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Intouch Solutions

DECEMBER 6, 2021

Medical science liaisons and medical affairs personnel are becoming increasingly important customer-facing components of the team, as sales rep access continues to be limited. It’s time to stop looking backward, and instead, look inside our organizations to recognize and weed out lingering, hindering assumptions and approaches.

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The Pharma Data

SEPTEMBER 7, 2020

New pivotal data from ASCLEPIOS trials evaluating the efficacy and safety of Kesimpta in a subgroup of treatment-naïve RMS patients will be presented for the first time 1 . In this extended analysis, Kesimpta showed a safety profile that remains consistent with data reported in the Phase II and III clinical trials 5.

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Cloudbyz

FEBRUARY 27, 2023

Pharmacovigilance is a critical function in the pharmaceutical and life sciences industry. It involves the identification, assessment, and prevention of adverse effects or other drug-related problems. To meet the growing demand for pharmacovigilance, companies are turning to technology solutions to streamline their operations.

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Cloudbyz

APRIL 2, 2021

CHICAGO, April 1, 2021 /PRNewswire/ — Cloudbyz, the leading maker of 100% cloud based, innovative Clinical Trial Management solutions (CTMS) partnered with ComplianceQuest, the leading provider of 100% cloud-native, next-generation enterprise Quality and Safety Management solutions (QMS and EHS) announces a partnership with.

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pharmaphorum

OCTOBER 18, 2021

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Where we can integrate or streamline processes, we should. 8 It’s encouraging to see this as one of the goals in the EMA’s 2025 Regulatory Sciences Strategy. We have learned so much.

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WCG Clinical

JUNE 12, 2023

We need to be talking about “participant engagement,” which better reflects the integral role participants play in the entire research process. Engaging participants and cultivating trust is increasingly critical to clinical trial success, especially as trials become more complex. We need their insights.

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The Pharma Data

AUGUST 29, 2020

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

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The Pharma Data

AUGUST 29, 2020

Compared with baseline values on eculizumab alone, LNP023 increased Hb by a clinically relevant 2.87 In the study, LNP023 given orally resulted in transfusion avoidance and meaningful clinical benefit in PNH patients who remained anemic and dependent on transfusions despite standard of care anti-complement treatment,” said Prof.

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The Pharma Data

JULY 21, 2021

Over an initial period of ten years, the collaboration will focus on four key areas: Enable the next generation of Black and African American leaders by creating equitable access to high quality education and professional development for future leaders, in health science, technology and business-related fields.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a testament to our commitment to advance science and investigate potential treatments that reimagine care and address significant unmet needs at all parts of the RMS journey.”. Results from the ASCLEPIOS I and II studies showed that compared with teriflunomide, ofatumumab: Significantly reduced the ARR by 51% (0.11

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Drug Discovery World

FEBRUARY 5, 2024

As long as drug discovery, development and commercialisation activities and budgets continue to be managed in isolation, and Generative AI projects applied in a piecemeal fashion to individual applications, the pharma industry risks inhibiting the technology’s broader potential.

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