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

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. Everyone may use different software systems to manage these documents.

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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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PPD

OCTOBER 17, 2024

Drug developers of all sizes are working to optimize each step in the clinical research process from site selection to complex logistics, managing evolving regulations, and patient recruitment and retention strategies. When sponsors are armed with this knowledge, it expedites the ability to expand and scale CGT development.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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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

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.

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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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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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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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Advarra

JANUARY 10, 2024

There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. However, adopting eSource is challenging for many research facilities. Research sites may elect to collect data using eSource, paper source, or a combination of the two.

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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

DECEMBER 1, 2022

HIPAA statements are typically provided to participants in one of two ways: Standalone document in addition to the ICF. For clinical research, this may include local researchers sharing the information with a third party, or, in the case of a partial waiver of Authorization, reviewing PHI for recruitment purposes.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Some examples of often-forgotten research costs include: Costs associated with trial participants: These include the costs of recruiting participants, screen failures, and screening activities.

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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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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

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?

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Clinical Trials Trials FDA Clinical Research 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 ).

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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. This includes everything from clarifications sought from individual regulatory authorities to Q&A documents, other professional publications and conference presentations.

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Agency IQ

AUGUST 18, 2023

The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation. government, so FDA’s regulations are technically parallel to HHS’.

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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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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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Agency IQ

AUGUST 11, 2023

Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management.

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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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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 is also due to revise 24 other guidance documents at that time.

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Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

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Advarra

SEPTEMBER 27, 2023

If there’s one constant in clinical research, it’s change. With continual innovations and transformations, establishing a human research protection program (HRPP) can help many research institutions adapt to these changes while upholding the highest ethical standards.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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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.

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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

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Agency IQ

AUGUST 9, 2024

FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans. While the new version of the guidance is greatly expanded as compared to an earlier version from 2022, it has left plenty of important questions unanswered.

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Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

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Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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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. The goals for Annex 2 are focused, in part, on DCT issues.

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Denmark posts guidance on decentralizing clinical trials. Draft Report. .

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