Perficient: Drug Development

NOVEMBER 20, 2024

Prioritize assets based on compliance requirements and risk levels. Intel and Honeywell : Investing in quantum hardware and research collaborations to tackle cybersecurity challenges. Observe Develop a complete inventory of cryptographic assets from both a network and application perspective. What Can Be Done Today?

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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Without clinical research, these medical breakthroughs would remain out of reach for patients. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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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 97

BioPharma Drive: Drug Pricing

DECEMBER 11, 2023

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

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Science Compliance Marketing Research 152

Drug Patent Watch

FEBRUARY 12, 2025

The generic drug development process involves several stages, from patent research to regulatory approvals. Here are a few: Thorough Patent Research : Conducting comprehensive patent research is critical to identifying potential patent challenges and developing a robust strategy to overcome them.

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Drug Development Drugs Compliance Regulations 81

Advarra

JULY 26, 2022

As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. While there isn’t a significant amount of research on cannabidiol (CBD), it’s easily accessible in the U.S. This can make research challenging, but not insurmountable. Funding Research on Cannabis.

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Regulations Research FDA FDA Approval 97

Drug Patent Watch

MARCH 17, 2025

That's why it's essential to develop a well-thought-out strategy that takes into account factors such as market research, regulatory compliance, and marketing tactics. Regulatory compliance : Ensuring that all necessary approvals and certifications are in place before launching the product.

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PPD

JULY 29, 2024

The benefits of utilizing AI in clinical research Patient recruitment and diversity AI is increasingly being utilized in the recruitment process for clinical trials , aiming to connect individuals with potential benefits from investigational treatments.

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.    The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years.

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H1 Blog

NOVEMBER 15, 2023

However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan. In this blog post, we will explore why compliance is critical in medical affairs and how it can make or break successful KOL engagement strategies.

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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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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 Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Clinical Development Compliance Clinical Trials 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

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. So, how can sponsor, contract research organization (CRO), and site teams better collaborate to improve quality and efficiency in their studies? In addition, many research trials are conducted over the course of many years.

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Compliance FDA Clinical Trials Trials 52

FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M. Clinical Trials.

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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. Compliance and Regulatory Bodies Meeting critical study milestones is often dependent on compliance with relevant GxP requirements.

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Clinical Research Research Compliance Clinical Trials 52

ACTO

DECEMBER 17, 2024

These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

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Compliance Government Pharmaceutical Companies Pharmaceuticals 52

Perficient: Drug Development

FEBRUARY 27, 2025

trillion in disposable income according to research by the Return on Disability Group. Those Guidelines will be technically sound and used by practitioners across the globe, minimizing risk of non-compliance. And this form of research can be quite affordable and effective. In the U.S. alone people with disabilities have 1.3

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Compliance Research Marketing Production 52

Advarra

APRIL 23, 2024

Evolving regulations, technological advancements, changing societal norms, and new research methodologies can cause an organization to pause and think, “Does our human research protection program (HRPP) have the proper expertise, policies, and procedures in place? Are we ready for increasing new single IRB (sIRB) mandates?

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Research Compliance International Regulations 52

The Premier Consulting Blog

NOVEMBER 6, 2024

Improved convenience and patient compliance: ICPs can offer improved convenience for patients by requiring only one device, rather than two or more separate inhalers – ultimately resulting in better patient compliance. The goal of ICPs is to improve the quality of life for patients suffering from chronic respiratory diseases.

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Production FDA Compliance Disease 52

Advarra

SEPTEMBER 7, 2023

Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A robust HRPP is comprised of many individuals and programs throughout an organization, and everyone works together toward the common goal of protecting research participants. What is an HRPP?

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Research Clinical Trials Compliance Regulations 52

FDA Law Blog: Drug Discovery

MARCH 3, 2025

From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. Hyman, Phelps & McNamara, P.C.s FDA Law Blog is a conference media partner.

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Compliance FDA Marketing Therapies 52

Quanticate

AUGUST 19, 2024

In recent years the requirement for maintaining a robust audit trail has become crucial for ensuring data integrity, transparency, and compliance with regulatory requirements. An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial.

Regulations 52

Regulations Clinical Research Clinical Trials Compliance 52

Advarra

AUGUST 22, 2023

As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is compliant and safe for participants. For research administrators, having a robust human research protection program (HRPP) in place is vital.

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Research Compliance Regulations 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

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Visibility into and control of the financial aspects of a site’s research portfolio are key to building a successful financial site workflow.

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Clinical Research Research Clinical Trials Compliance 52

PPD

JULY 16, 2024

Regulatory interpretation and analysis in the real world Across the complex landscape of medicinal product and medical device development, solid regulatory expertise and effective safety reporting are key to ensuring patient well-being and statutory compliance.

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Compliance Regulations Production Trials 98

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations.

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Clinical Research Trials Clinical Trials Research 69

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

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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Compliance FDA Drugs Pharmaceuticals 97

FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed.

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Clinical Research FDA Research Clinical Trials 59

Chemical Biology and Drug Design

APRIL 16, 2023

The advantages of TEs include increased patient compliance, bypassing first-pass metabolism, including non-toxic raw components, being a noninvasive method of drug delivery, being more stable, biocompatible, biodegradable, and administered in semisolid form. In the presence of ethanol and an edge activator, skin permeability can increase.

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Drugs Compliance Research Marketing 100

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

Drug Patent Watch

FEBRUARY 26, 2025

Regulatory compliance : Biologics are subject to strict regulatory requirements, including those related to manufacturing, labeling, and marketing. Conduct thorough research : A thorough search of prior art and regulatory requirements is essential to identify novel and non-obvious features.

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Drugs Government Regulations Compliance 59

thought leadership

MARCH 31, 2025

Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the increasing complexity of clinical research.

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