XTalks

MAY 9, 2023

As the demand for clinical trials continues to grow, so does the need for skilled professionals who can manage complex trial operations and ensure that studies are conducted in compliance with regulatory requirements. If you’re considering a career in clinical research, read on to learn more about this rewarding career.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

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Genome Genomics Life Science Gene Therapy 139

ACRP blog

APRIL 5, 2023

AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.” This has led to the emergence of a new ‘pharmaceutical intelligence’ that has allowed the industry to move away from traditional, slow-moving, and costly processes,” Lyons writes. “AI

Big Data 52

Big Data Clinical Trials Clinical Trials Life Science 52

The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies.

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Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

FEBRUARY 4, 2021

Adams believes this positive start to the year is a sign that life science and medical device companies are looking for expert partners who understand the operational and regulatory challenges facing them and can deliver scalable solutions that meet their unique requirements. “It

Life Science 52

Life Science Clinical Trials Clinical Trials Regulation 52

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

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Life Science Compliance Regulation Cosmetics 93

XTalks

DECEMBER 4, 2023

Matthew Confeld, PharmD, PhD Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials In this Xtalks Spotlight edition, Xtalks spoke with Matthew Confeld, PharmD, PhD, Assistant Director of Clinical Research Methodology at Worldwide Clinical Trials , about Project Optimus and what it means for oncology programs.

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Development Drugs Clinical Trials Clinical Trials 111

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. Clinical Data Pipeline for Data Review and Analyses.

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Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. for the period 2020-2030 (Source: PS market research). Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. for the period 2020-2030 (Source: PS market research). Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. Richard Lee, MD, Senior Medical Director of the Medical Department at the global contract research organization (CRO) Medpace. What are Decentralized and Hybrid Clinical Trials?

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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

AUGUST 25, 2020

The regulator defines these mission-critical inspections as those that would impact US patients’ access to medical products used to treat, diagnose or prevent serious diseases for which there is no other option available. Having a good history of compliance with the FDA could help manufacturers avoid import delays.

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Manufacturing Clinical Trials Clinical Trials Production 89

pharmaphorum

JULY 4, 2022

Together, the webinar panellists explored the potential of medical informatics solutions and methods in rare disease research, studies, data optimisation, and usability to overcome these challenges, all whilst maintaining compliance with data protection regulations and a patient-centric approach.

Genome 105

Genome Genomics Research Medicine 105

Drug Discovery World

DECEMBER 8, 2023

The need for cell and gene therapy development standardisation Presently, a total of 3,866 cell and gene therapies are in various stages of development , spanning from pre-clinical research to pre-registration phases. The data needed for analysis takes months to collect and has a high cost.

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Gene Therapy Gene In-Vitro Development 64

Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharma Business Blog

NOVEMBER 24, 2022

EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

DECEMBER 12, 2023

This is crucial for maintaining patient privacy in accordance with global regulations. The integrated systems used, such as Medpace ClinTrak ® , are designed to protect patient information by removing identifiable data at the source, which is essential for regulatory compliance.

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Trials Clinical Trials Clinical Trials Genetics 111

XTalks

FEBRUARY 4, 2021

Bernard, executive vice president for research and chief research officer at Vanderbilt University Medical Center, shared his experience in helping set up a DNA and clinical data resource called BioVU. Dr. Bernard’s clinical research interests are in the areas of sepsis and acute respiratory distress syndrome (ARDS).

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Research Biobanking Drugs Genome 98

Velocity Clinical Research

MAY 30, 2024

Being a clinical research site organization that deals with sensitive patient data, it is encouraging and comforting to see that these models consider privacy, security, and compliance as critical factors. Aspects of GPT-4o are General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) compliant.

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Clinical Trials Clinical Trials Trials Life Science 59

pharmaphorum

MARCH 5, 2021

For International Women’s Day, Medidata’s global compliance and strategy lead Fiona Maini discusses the importance of increasing female participation in clinical trials and how technology may solve some of the barriers. We need to learn from the lessons from research to regulation and push further.”.

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Clinical Trials Clinical Trials Trials Vaccination 116

Pharmaceutical Technology

FEBRUARY 20, 2023

We look forward to deepening our collaboration in next decades and contributing more to state-of-the-art clinical trials for efficient medicine to patients’ benefits throughout the world”, says XU Yi, CEO Teddy Clinical Research Laboratory. SZ) and Tigermed (300347.SZ SZ) and Tigermed (300347.SZ

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Research Clinical Trials Clinical Trials Clinical Research 130