Quanticate

SEPTEMBER 11, 2024

The Importance of SAS Quality Control in Clinical Trials Quality control (QC) in clinical trials is essential for ensuring the integrity and reliability of data. By integrating SAS with robust QC methodologies, clinical trials can achieve higher standards of accuracy and compliance.

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Clinical Trials Trials Compliance Clinical Research 52

Advarra

FEBRUARY 13, 2024

Having a singular password could also potentially affect trial timelines. Since staff would temporarily be unable to properly access the necessary systems, it could lead to wasted time and trial delays. SSO also has the ability to enhance user accountability and compliance within an organization.

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Compliance Clinical Research International Research 52

Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Compliance Treatment 81

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. Clinical Trials. By John W.M.

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Compliance Online Pharmacies Clinical Trials FDA 57

PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. 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.

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Clinical Trials Trials Clinical Research FDA 98

Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. Outdated systems: Many organizations rely on legacy data management tools that fail to meet the demands of modern clinical trials.

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Clinical Trials Trials Science Production 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

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. 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.

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Clinical Trials Trials Compliance Regulations 52

Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11.

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Compliance Regulations Clinical Trials Packaging 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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Clinical Trials Trials Compliance Clinical Research 52

Fierce BioTech

SEPTEMBER 7, 2023

In this interview, Eric Klaver, the DCT regulatory director for decentralized clinical trials at IQVIA, aiding in compliance of the DCT strategy and platform, shares how IQVIA supports investigator | With IQVIA’s clinical trial solutions and flexible site support strategies, decentralized trial elementss are being leveraged to enhance patient- centered (..)

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Trials Clinical Trials Compliance 59

Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Clinical Trials Trials Treatment Compliance 52

Quanticate

SEPTEMBER 30, 2024

In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.

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Clinical Trials Compliance Trials 98

Quanticate

MAY 30, 2024

The ALCOA principles guide and model a company’s policies and procedures to help ensure that regulatory compliance is being maintained, and adheres to policies such as GCP and GMP. The ALCOA principles play a critical step in ensuring data integrity and compliance is of an excellent standard.

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Clinical Trials Compliance Trials FDA 59

Vial

MAY 13, 2024

However, progress from molecule to approved drug is hampered by extremely high costs and lengthy clinical trials , and approximately 90% of drugs that reach clinical trials fail. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 An estimated 80% of clinical trials do not finish on time.

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Clinical Trials Trials Drug Development Production 52

BioPharma Drive: Drug Pricing

JULY 3, 2023

iliomad Health Data can help you maintain GDPR compliance. What is the GDPR and why does it matter to your life sciences company.

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Compliance Trials Science 98

The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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Compliance Licensing Licensing Clinical Trials 52

thought leadership

SEPTEMBER 12, 2023

In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever.

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Clinical Trials Trials Compliance Pharmaceuticals 40

Advarra

JANUARY 18, 2024

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Continue to monitor training engagement and accuracy throughout the trial.

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Clinical Trials Trials Compliance Clinical Research 52

ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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Clinical Trials Regulations Trials FDA 52

H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Clinical Trials Trials FDA Treatment 52

Conversations in Drug Development Trends

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. Patient Compliance One of the most important findings of the study was the difference in patient compliance between the two sample collection methods.

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DNA Compliance Clinical Trials Trials 72

PPD

AUGUST 9, 2023

The increased adoption of decentralized clinical trial (DCT) designs has revolutionized how the industry approaches clinical studies. In short, for clinical trial design to truly benefit from the digital revolution, data flow, management and analysis are the next frontiers.

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Clinical Trials Trials Clinical Research Regulations 52

Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. The lengthy process adversely impacts clinical trial start-up time and trial costs.

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Clinical Trials Trials Clinical Research Research 52

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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Trials Clinical Trials International Regulations 59

DS in Pharmatics

OCTOBER 17, 2024

These specialists offer essential expertise in drug development, clinical trial design, regulatory compliance, and market strategy. Improve your pharmaceutical product’s chances of success by engaging a biopharmaceutical consultant. By benefiting from their […]

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Clinical Trials Compliance Drug Development Pharmaceuticals 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.

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Regulations Clinical Research Clinical Trials Compliance 52

DrugBank

OCTOBER 30, 2024

From advancing drug discovery, managing clinical trials, or developing new healthcare solutions, reliable and flexible access to quality data is essential for success. From early-stage drug discovery to complex clinical trials, Snowflake scales alongside your work to meet your growing demands. 

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Production Clinical Trials Packaging Compliance 75

Advarra

OCTOBER 31, 2024

Technology costs: fees for site-owned platforms such as a clinical trial management system (CTMS), eRegulatory management system, eSource platform, or any other specialized digital solution used during the trial. Regulatory costs: fees for institutional review board (IRB) approvals, data privacy compliance, and audits.

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Research Trials Compliance Clinical Trials 52

PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Strategies to Increase Diverse Populations in Dermatology Clinical Trials 1. ” Adding to this momentum, in December 2022 the U.S.

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Clinical Trials Trials Clinical Research Disease 59

Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. The greater the risk, the more likely a series of trials for market clearance or approval will be required.

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Clinical Trials Trials Production Regulations 52

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

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Clinical Trials Trials International Clinical Research 52

PPD

JUNE 29, 2023

To be competitive, drug developers must run their trials efficiently and within budget and timelines, while still maintaining quality to support authorization. My personal experience drives my passion to enable drug developers in the quest for better treatments with less complicated compliance requirements.

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Clinical Trials Trials Drug Development Clinical Research 52

Quanticate

JUNE 7, 2024

Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials

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Clinical Trials Compliance Trials 59