Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

Clinical Research

Advarra

JULY 3, 2025

10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3?

Compliance

ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. Once perceived as a regulatory gray zone, the Indian clinical research ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research.

Clinical Trials

PPD

JUNE 17, 2025

This approach provides sponsors with the agility, efficiency and speed needed to expand clinical research into emerging markets or remote areas with highly qualified professionals in a cost-efficient manner.

Clinical Development

Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

Clinical Research

PPD

JUNE 20, 2025

Prioritizing participant comfort and convenience improves compliance as well as patient recruitment and retention rates, in turn increasing the likelihood that studies are able to be completed on time and on budget. The emphasis on patient-centric trial designs is becoming increasingly important in IPF research.

Clinical Development

Drug Target Review

MAY 5, 2025

Evolve from data generation to actionable knowledge application Taking action based on the knowledge our data provides is paramount in modern drug development, especially with so many fragmented databases and source systems with pre-clinical, clinical development, manufacturing and commercial functions.

Clinical Development

PPD

APRIL 14, 2025

Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

Clinical Research

Conversations in Drug Development Trends

JANUARY 6, 2025

Regulatory Compliance and Ethical Considerations Adaptive trials, although flexible and efficient, must adhere to strict regulatory and ethical standards. Real-World Data Integration Another emerging trend in clinical research is integrating real-world data (RWD) into the designs of adaptive trials.

Trials

Advarra

MAY 14, 2025

With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Sponsors often ask, How will the FDA view this?

FDA

Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

Clinical Research

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.

Clinical Research

Quanticate

APRIL 15, 2025

The Clinical Data Interchange Standards Consortium (CDISC) establishes globally recognised standards that ensure data accuracy, consistency, and compliance in clinical research.

Clinical Research

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.

Clinical Research

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

Clinical Research

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

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. In other words, the inspectional output was inversely proportional to the importance of clinical research.

Clinical Research

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.

Clinical Research

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. SSO also has the ability to enhance user accountability and compliance within an organization.

Compliance

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.

Clinical Research

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.

Clinical Research

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

Clinical Research

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.

FDA Compliance

Broad Institute

JANUARY 24, 2024

Compliance agreements: Terra can now sign HIPAA Business Associate Agreements for U.S. The responsible use of omics and health data requires robust security and compliance controls, but also ease of access and use to unlock the scientific potential,” said Jonathan Carlson, Managing Director, Microsoft Health Futures.

Bioinformatics

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.

Clinical Research

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.

Clinical Trials

Quanticate

APRIL 29, 2025

Clinical research is evolving as technology advancements enable more sophisticated drug development methods, dramatically increasing the speed, volume, and complexity of clinical trial data generation.

Clinical Trials

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.

Therapies

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.

Vaccine

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.

Clinical Trials

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

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

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. Study sponsors need quality results as quickly as possible to maximize profit-generation opportunities in the market.

Clinical Trials

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

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.

Clinical Trials

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.

Compliance