Advarra

OCTOBER 17, 2023

This fear of non-compliance can significantly affect a site’s bottom line. Allocating resources: Clinical research is resource-intensive, requiring funding for staff salaries, equipment, supplies, participant recruitment, and administrative overhead.

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Clinical Research Research Clinical Trials Compliance 52

Advarra

JUNE 27, 2023

This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy.

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Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

JULY 9, 2024

Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.

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Clinical Research Treatment Research Clinical Trials 52

ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FDA Compliance Clinical Trials Compliance Trials 52

Advarra

MARCH 14, 2023

Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows.

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Clinical Research Research Compliance Clinical Trials 52

Advarra

MARCH 31, 2023

Among the various regulatory bodies providing oversight on clinical research, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

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Engineering Clinical Research Research Virus 52

Quanticate

SEPTEMBER 11, 2024

Leveraging SAS (Statistical Analysis System) for QC processes offers a powerful solution for clinical researchers. By integrating SAS with robust QC methodologies, clinical trials can achieve higher standards of accuracy and compliance.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

PPD

NOVEMBER 4, 2024

The PPD clinical research business of Thermo Fisher Scientific has conducted a comprehensive survey involving 150 drug developers from around the world. This year’s findings reveal a nuanced landscape where rising clinical trial costs, complex protocol designs and patient recruitment issues have emerged as significant challenges.

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Drug Development Clinical Trials Clinical Research Trials 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

NOVEMBER 14, 2024

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

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Clinical Trials Trials International Clinical Research 52

Advarra

OCTOBER 31, 2023

A common misconception in the manufacturing and research development landscape is quality systems can be bought off the shelf and there are no significant differences among the proliferation of quality systems. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

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Compliance Clinical Research Clinical Trials Trials 52

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. However, it is often unengaging, cumbersome, and manual.

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Clinical Trials Trials Compliance Clinical Research 52

FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Her expertise spans a range of critical areas including: human subject protections, clinical trial conduct, development strategies, FDA interactions, and enforcement action responses. Hyman, Phelps & McNamara, P.C.

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Drug Development Molecular Biology Compliance Clinical Trials 52

Conversations in Drug Development Trends

APRIL 8, 2024

Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.

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Clinical Trials Clinical Research Trials Compliance 75

Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance. Defining eSource and EDC First, it may be helpful to define e Source and EDC.

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Compliance Clinical Research Trials Research 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

NOVEMBER 18, 2024

For example, a biotech developer creating a new antiviral drug could miss a change in one aspect of a regulatory requirement, only to discover at the end of the process that they must restart a clinical trial or resubmit portions of their data.

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Clinical Trials Regulations Compliance Production 52

Conversations in Drug Development Trends

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging.

Clinical Trials 52

Clinical Trials Compliance Trials Clinical 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.

Clinical Trials 52

Clinical Trials Clinical Research Trials Compliance 52

PPD

JUNE 24, 2024

Explore the unique aspects of mega trials, the challenges they pose to vaccine developers, what the future holds for these large, complex trials, and how a partnership with an experienced provider of clinical research solutions can enable success.

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Vaccine Trials Clinical Trials Laboratories 97

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. This leads to cost savings and faster timelines.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Advarra

NOVEMBER 9, 2023

This helps each site follow consistent procedures, which reduces the risk of errors, omissions, or delays in meeting study milestones due to regulatory non-compliance. This guarantees consistency and compliance. This proactive approach can prevent delays, compliance issues, and costly setbacks.

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Compliance Clinical Trials Trials Research 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

Vial

MAY 22, 2024

Introduction Veeva Systems and Vial CRO ( contract research organization ) represent stakeholders in the clinical research landscape, which play integral roles in the successful execution of clinical trials. Conclusion Vial CRO and Veeva Systems are tech-first solution providers in the clinical trial landscape.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Clinical Trials Clinical Research Trials Laboratories 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. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

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Therapies Clinical Trials Clinical Research Trials 52

H1 Blog

JULY 30, 2024

The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements. Find out more by requesting a demo today.

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FDA Clinical Trials Compliance Pharma Companies 59

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Our GMP Lab team, which provides PPD® Laboratory services , has already received requests from clients who have chosen to transition as quickly as possible to stay ahead of these compliance requirements and perhaps be one step ahead of the competition.

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Packaging Laboratories Pharmaceutical Companies Compliance 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 is an Electronic Master File (eTMF)? .

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Research Clinical Trials Compliance Regulations 52

Advarra

DECEMBER 1, 2022

This policy requires domestic awardees and domestic sites conducting NIH-funded multisite research to be overseen by a single IRB of record. This rule was announced on June 21, 2016, with a compliance date of January 25, 2018. Click here for more information on the HHS compliance requirements. FDA Initiatives. An Age of sIRB.

Regulations 52

Regulations Compliance FDA Clinical Trials 52

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

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

Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

Laboratories 45

Laboratories Clinical Trials Clinical Research Compliance 45

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

PPD

OCTOBER 31, 2024

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 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.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 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