PPD

NOVEMBER 18, 2024

Effective monitoring of regulatory intelligence comes with big challenges The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.

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Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards. This compliance is crucial for the successful regulatory approval and dissemination of trial results.

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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

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Avoiding double billing: Avoid duplicate charges for budget items by ensuring compliance with the research billing plan. from the Food and Drug Administration [FDA]) Safety reporting (e.g.,

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Clinical Trials Trials Compliance Laboratories 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

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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Therapies Clinical Trials Clinical Research Trials 52

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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Clinical Trials Trials Compliance Clinical Research 52

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

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

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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Clinical Trials Trials Compliance FDA 40

PPD

SEPTEMBER 6, 2023

Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

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Clinical Research Regulations Packaging Drug Development 59

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. In three years of tracking safety reporting compliance with this client, their annual China EC Compliance rates averaged over 99%.

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Compliance Regulations Production International 52

Advarra

JUNE 14, 2022

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Annual reports to confirm ongoing compliance and maintain accreditation. Compliance with Applicable Regulations. Compliance with Other Requirements. IRB Clients.

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Compliance Regulations FDA Research 52

Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

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Clinical Trials Clinical Research Trials Compliance 52

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

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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Trials Clinical Trials Regulations FDA 80

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

Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations.

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Regulations Clinical Research Research Government 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.

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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

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.

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Clinical Trials Compliance Trials Laboratories 52

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. Exemptions: Despite its overarching reach, the proposal does carve out exemptions.

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Laboratories FDA Clinical Development Regulations 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. Keeping abreast of changes in regulatory frameworks guarantees compliance and minimizes regulatory-related delays.

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Trials Clinical Trials Compliance Treatment 81

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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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.

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Compliance Clinical Research Trials Clinical Trials 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

AUGUST 9, 2023

Harmonized Clinical Trial Data Structures to Drive Innovation within Decentralized Clinical Trial Models Data is the fuel of the digital enterprise — it is the lifeblood needed to execute key processes, make decisions and achieve regulatory compliance. This said, there is regulatory uncertainty that must be resolved.

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Clinical Trials Trials Clinical Research Regulations 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

Perficient: Drug Development

SEPTEMBER 25, 2024

Limited data accessibility : Researchers frequently lack efficient ways to access and interpret the specific data relevant to their roles. Collaboration barriers : Disparate teams often struggle to share insights and work cohesively, slowing down the research process.

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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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Clinical Trials Clinical Research Trials Hospitals 52

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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Research Compliance Clinical Research Government 52

PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

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Laboratories Assay Development Small Molecule Drug Development 52

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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Clinical Research Research Compliance Clinical Trials 52

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?

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Advarra

NOVEMBER 10, 2022

This blog highlights some of the major proposed changes and how they may impact the clinical research community. . In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. . multisite research and trials).

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Regulations FDA Research Trials 52

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