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. The FDA, HHS, and research and informed consent policies In the U.S.,

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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.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Advarra

DECEMBER 1, 2022

The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed decision about whether to participate in a clinical trial. Why HIPAA in Research? PHI is a subset of what is termed “individually identifiable health information.”

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Clinical Trials Trials Regulations Research 52

PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Clinical Trials Trials Clinical Research Research 52

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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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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Clinical Trials Laboratories Regulations Clinical Research 59

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.

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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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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. Amid a constantly evolving global regulatory environment, companies must be proactive, well-informed and flexible.

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Compliance Regulations Production Trials 98

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review? appeared first on Advarra.

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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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Clinical Trials Treatment Clinical Research Trials 98

PPD

AUGUST 5, 2024

Global expertise and 7 key lessons learned The PPD clinical research business of Thermo Fisher Scientific has extensive history working with PAH clinical trial sites globally (more than 3,500 sites across 53 countries in the past five years). From that experience, we offer seven key takeaways.

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Clinical Trials Trials Clinical Research Disease 98

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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Clinical Trials Trials Clinical Research FDA 98

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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FDA Regulations Trials Research 40

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?

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Research Clinical Trials Compliance Regulations 52

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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Trials Clinical Trials Regulations FDA 80

Advarra

NOVEMBER 10, 2022

This blog highlights some of the major proposed changes and how they may impact the clinical research community. . Proposed changes to informed consent requirements include new basic elements similar to those included in the revised Common Rule. Again, this is similar to what HHS regulations currently permit. .

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Regulations FDA Research Trials 52

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

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Regulations Compliance FDA Clinical Trials 52

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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Regulations Clinical Research Research Government 52

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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Clinical Research Doctors Research Regulations 52

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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Clinical Trials Trials Clinical Research Treatment 52

Advarra

APRIL 19, 2023

IVDs are used in almost all clinical research. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.

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Research Clinical Trials Regulations FDA 52

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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Clinical Trials Trials Clinical Research Disease 59

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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Clinical Trials Trials FDA Clinical Research 52

Fierce BioTech

JUNE 15, 2023

Logos Attribution 0 Attribution 0 Primary Category Biotech On Demand Off Enable Automatic On Demand On Registration Login Link Already registered?

DNA 52

DNA Clinical Research Regulations Disease 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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Trials Clinical Trials Compliance Treatment 81

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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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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Clinical Trials Trials Compliance Regulations 52

Vial

JUNE 12, 2024

Introduction Patient-reported outcomes (PROs) refer to information about a patient’s health that is shared directly by the patient and not influenced by the interpretation of any other. Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research.

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Clinical Trials Trials FDA Clinical Research 52

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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Clinical Trials Clinical Research Trials Hospitals 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.

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Clinical Research Clinical Development International Engineering 52

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor.

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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. Most large organizations have a simplified mobile experience to log in, authenticate, and access various platforms needed to conduct research.

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Compliance Clinical Research International Research 52

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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Therapies Clinical Trials Small Molecule Immune Response 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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Therapies Clinical Trials FDA Trials 52

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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Clinical Trials Trials Clinical Research Regulations 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).

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