Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Documents are in an eISF?

Research 52

Research Clinical Trials Compliance Regulations 52

Advarra

FEBRUARY 13, 2024

Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. Users can log in via SSO once using their credentials, with no need to re-authenticate to access other internal applications leveraging SSO.

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Compliance Clinical Research International Research 52

PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

Drug Development 52

Drug Development Compliance Clinical Trials Trials 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Trials Clinical Trials Compliance Treatment 81

Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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Pharma Companies Clinical Trials Compliance Trials 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. How and What to measure?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This research ultimately influenced the creation of a new submission process for the client.

Compliance 52

Compliance Regulations Production International 52

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Clinical Trials Trials Clinical Research Compliance 52

Drug Target Review

SEPTEMBER 26, 2023

She completed a PhD at Durham University which focused on investigating the mechanisms of cardiotoxicity of cancer therapies using clinically relevant in vitro human models of cardiac physiology paired with novel methodologies to evaluate structural and functional toxicities. Ther Innov Regul Sci. International Union of Pharmacology.

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Drugs FDA Disease Animal Testing 111

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. new medicines.

Clinical Trials 40

Clinical Trials Trials Clinical Development Clinical Research 40

Vial

MARCH 15, 2024

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Escalation plans: Use internal and sponsor escalation plans to navigate any challenges arising during the negotiation process. from the Food and Drug Administration [FDA]) Safety reporting (e.g.,

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

The Pharma Data

NOVEMBER 10, 2020

Moreover, these papers explored the biological effects of molecular hydrogen, including its effects on neutralizing toxic free radicals in vivo, such as hydroxyl radical (-OH) and peroxide nitrate anion (ONOO-), anti-inflammatory and anti-apoptotic effects, and the ability to regulate cell signal transduction. About Asclepius Meditec.

Hospitals 52

Hospitals Clinical Trials Treatment Therapies 52

The Pharma Data

DECEMBER 27, 2020

Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital. “We The development of novel drugs requires focused drug discovery efforts, world-class research and development capabilities, state-of-the-art clinical research and significant capital investment.

Science 52

Science Hospitals Treatment Clinical Trials 52

PPD

DECEMBER 12, 2023

Navigating the Intricacies of the Follow-the-Sun Model in Clinical Research The implementation of a follow-the-sun model, which leverages global resources in different time zones to assure continuous operations, requires a thoughtful approach to cultures, communication and collaboration for effective results.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Small Molecule 40

Small Molecule Clinical Development Production Science 40

Drug Target Review

OCTOBER 25, 2024

Alzheimer’s Association International Conference; 2024 July 28 – August 1; Philadelphia, PA. FMNL2 regulates gliovascular interactions and is associated with vascular risk factors and cerebrovascular pathology in alzheimer’s disease – acta neuropathologica. Progress in molecular biology and translational science. Poster 362.

Disease 59

Disease Clinical Trials Therapies Science 59

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

Pharmaceuticals 40

Pharmaceuticals Clinical Trials Small Molecule Disease 40

The Pharma Data

JANUARY 13, 2021

Optimum Strategic Communications (International Media and European Investor Enquiries). Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. . .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

DECEMBER 17, 2020

Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University and Weinblatt is the co-director of Clinical Rheumatology at the Brigham and Women’s Hospital. Immune Regulation – U.K.-based based Immune Regulation Ltd. Sinai Health Network.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Policy-wise, this is still a work in progress.

FDA 40

FDA Research Clinical Trials Trials 40

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

Drug Development 40

Drug Development Clinical Trials Trials Vaccine 40

The Pharma Data

NOVEMBER 10, 2020

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. NEW YORK and LONDON, Nov. We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

Drug Target Review

DECEMBER 13, 2024

Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Fcgamma Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates. Meng Y, Wang X, Yang J, Zhu M, Yu M, Li L, et al. Discov Oncol. 2024;15(1):327. 2022;39(1):89-103.

Therapies 52

Therapies Treatment Clinical Trials Drugs 52

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He currently serves as chair of the medical and scientific advisory group and as a member of the Board of Directors of the Alzheimer’s Association. Corey Davis Ph.D.,

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. The regulation of dietary supplements in the U.S.

Therapies 40

Therapies Science FDA Production 40

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

Science 40

Science FDA Production Trials 40

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments. Japan, and China.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.

Regulations 40

Regulations Trials Clinical Trials Science 40

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40