Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). RFIs must be addressed in the clinical trial information system (CTIS) within 10 calendar days for validation and 12 calendar days for assessment.

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Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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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

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

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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. Responses to the draft guideline highlighted DCT issues. Next, the U.S.

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thought leadership

SEPTEMBER 30, 2024

However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes. These changes can impact staffing requirements throughout the study.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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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).

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Vial

FEBRUARY 21, 2024

These companies are equipped with the expertise and resources to lead successful medical device clinical trials. Medical device sponsors often seek out CROs so they can outsource services such as clinical research, site selection, trial design, and regulatory consulting.

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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 To learn about the history of these trial technologies and their adoption within the clinical research industry, read more here !

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PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. It also records data on a centralized system available to both the research site and sponsor, so all parties have access to up-to-date information.

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PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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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.

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Advarra

NOVEMBER 17, 2022

Today, many clinicians and researchers acknowledge giving children drugs with no supporting pediatric research data and adjusting dosing based on weight likely isn’t the most effective way to treat them. The ethical way forward is to offer children [1] better opportunities to participate in clinical research.

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Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. The industry faces several persistent hurdles: Data fragmentation: Research teams often struggle with siloed information across departments, hindering collaboration and comprehensive analysis.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Thus, while the same types of safety endpoints need to be evaluated, the studies done to do so often look different compared to those for a small molecule.

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PPD

AUGUST 9, 2023

Therefore, regulators and the industry must agree on accepted methods for analyzing data collected from wearable devices. Accessing structured, clean data is also a significant challenge because robust data-cleansing processes are typically required before clinical trial data can be used.

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Olympian Clinical Research

JULY 29, 2021

While we don’t know all the technicalities of what causes migraines on a neurological level, most scientists believe that they are the result of abnormal brain functioning, affecting your brain’s nerve signals, possibly the ones that regulate pain. Contact our office to be signed up to learn more information !

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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. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

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The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.

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Laboratories FDA Clinical Development Regulations 52

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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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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Olympian Clinical Research

SEPTEMBER 3, 2020

Sit back and take a look at yourself, your life, and your depression – understand how things affect you, what situations may overwhelm you or exacerbate your depression, and take steps to improve your life and do what’s best for you based on that information. Sleep is especially important in regulating mood.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating  Collaborating with patients plays a fundamental role, as each treatment discussion and decision-making process varies based on individual patients. 

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Advarra

JUNE 14, 2022

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Compliance with Applicable Regulations. Abiding by the appropriate research regulations is the right thing to do, it’s legally required, and it’s the heart of the IRB’s mission.

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Compliance Regulations FDA Research 52

Conversations in Drug Development Trends

APRIL 3, 2024

Patient Education and Advocacy Collaboration : Making sure proper educational materials are available at sites and with patient advocacy organizations helps bring awareness to your trial and drive informed participation. These include ensuring informed consent, particularly around the risks and benefits of participation.

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Agency IQ

AUGUST 18, 2023

FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. BY LAURA DIANGELO, MPHAUG 17, 2023 12:08 AM CDT The FDA, HHS, and research and informed consent policies In the U.S.,

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Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

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Agency IQ

AUGUST 11, 2023

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more.

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The Pharma Data

JANUARY 24, 2021

Their world-class physicians set new standards in comprehensive urologic patient care and continue to innovate with the most advanced treatments backed by clinical research. FACOS, Director of Clinical Research for MU stated “We are excited to work with Theralase for the NMIBC clinical study. Dr. Laurence H.

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PPD

AUGUST 28, 2024

Regulators and payors also demand a higher volume of data collection for these studies. Clear communication throughout the process further empowers patients to make informed decisions about their own care. There is a lot of competition in this area of drug development, and the regulatory landscape is increasingly dynamic.

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The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. For further information please visit www.abetterlifephama.com. About Transcend Biodynamics.

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