Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV. the effect on illnesses and side effects each dose may produce).

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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

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

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. Oftentimes, research staff are faced with logging into multiple systems, and with that comes remembering multiple passwords.

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Compliance Clinical Research International Research 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. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.

Engineering 52

Engineering Clinical Research Research Virus 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

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

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

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

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. It’s difficult to calculate a clinical trial’s ROI if the potential research outcomes are unknown. Calculating the ROI of studies is essential for a research site’s success.

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 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.

Research 52

Research Compliance Clinical Research Government 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.

Compliance 52

Compliance Clinical Research Clinical Trials Trials 52

Advarra

JUNE 5, 2023

In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant safety by convening a data safety monitoring board (DSMB), sometimes called a data monitoring committee (DMC) or independent safety monitoring board (ISMB).

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Research Clinical Trials Trials Clinical Research 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. Whether you’re new to IVD research or could use a refresher, this high-level overview will help you navigate IRB review requirements for IVDs.

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Research Clinical Trials Regulations FDA 52

Advarra

APRIL 27, 2023

Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and well-functioning society, the benefits of research would ideally be shared equitably among all social groups, regardless of race, age, gender, or ethnicity. This gives the research community (e.g.,

Clinical Trials 52

Clinical Trials Research Trials Clinical Research 52

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.

Compliance 52

Compliance Clinical Research Trials Research 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

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.

Drug Development 52

Drug Development Molecular Biology Compliance Clinical Trials 52

Conversations in Drug Development Trends

APRIL 25, 2024

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%.

Clinical Trials 52

Clinical Trials Compliance Trials Clinical Research 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

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

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

AUGUST 5, 2024

Where the historical goal was to delay progression of the disease, more recent research focuses on new medications and disease-modifying therapies with potential for generating clinical improvements and, ultimately, reversal of the disease. None offers a cure for PAH. From that experience, we offer seven key takeaways.

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Clinical Trials Trials Clinical Research Disease 98

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

However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products. This is where contract research organizations (CROs) come into play.

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Clinical Trials Trials Compliance Regulations 52

Advarra

NOVEMBER 9, 2023

Efficient and compliant study startup activities set the foundation for the entire research process. This blog explores the pivotal role QMS plays in study startup activities as well as how a right-sized QMS contributes to the overall success of clinical trials. This guarantees consistency and compliance.

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Compliance Clinical Trials Trials Research 52

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

Vial

FEBRUARY 15, 2024

To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1. The demand for clinical trial outsourcing services is on the rise. over the forecast period (2022-2030).

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Pharma Companies Clinical Trials Compliance Trials 52

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions. from 2024 to reach US$129.8 billion by 2029.

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Clinical Trials Clinical Research Trials Laboratories 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.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 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

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

Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. BioDAOs fund and incubate projects during the initial stages of translational research, often through IP-NFTs, even before a company is established.

Engineering 52

Engineering Research Clinical Trials Government 52

Advarra

AUGUST 18, 2022

In the last few years, the clinical research industry has seen a bigger push for electronic informed consent (eConsent) than ever before. eConsent can include something as small as research staff collecting an eSignature via PDF, or as large as using a comprehensive eConsent platform. Obtain and document informed consent.

Research 52

Research FDA Clinical Research Compliance 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

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.

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Drug Development Clinical Trials Trials Drugs 52