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Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. Errors jeopardize patient safety, regulatory compliance and trust. These domains are ripe for innovation.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.
Clinicalresearch 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.
The EU AI Act’s implications extend into clinicalresearch, 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.
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 clinicalresearch ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research.
The benefits of utilizing AI in clinicalresearch 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.
It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinicalresearch. Range of Services The range of services offered by a CDMO is another vital criterion.
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.
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. AI with a human purpose Herne speaks about AI in clinicalresearch with pragmatic focus. Unlearn is one of the few companies applying this approach at scale.
The Clinical Data Interchange Standards Consortium (CDISC) establishes globally recognised standards that ensure data accuracy, consistency, and compliance in clinicalresearch.
In the clinicalresearch 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.
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 clinicalresearch business of Thermo Fisher Scientific.
Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinicalresearch encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.
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.
According to GAO, FDA is facing challenges with clinicalresearch 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 clinicalresearch.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations.
Every day, clinicalresearch 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.
This fear of non-compliance can significantly affect a site’s bottom line. Allocating resources: Clinicalresearch is resource-intensive, requiring funding for staff salaries, equipment, supplies, participant recruitment, and administrative overhead.
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 clinicalresearch standards. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3?
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.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.
In response, the PPD clinicalresearch 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 clinicalresearch.
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.
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.
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.
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 clinicalresearch.
This approach provides sponsors with the agility, efficiency and speed needed to expand clinicalresearch into emerging markets or remote areas with highly qualified professionals in a cost-efficient manner.
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?
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.
Clinicalresearch is evolving as technology advancements enable more sophisticated drug development methods, dramatically increasing the speed, volume, and complexity of clinical trial data generation.
Drug developers of all sizes are working to optimize each step in the clinicalresearch 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.
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 clinicalresearch solutions can enable success.
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 clinicalresearch. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.
Leveraging SAS (Statistical Analysis System) for QC processes offers a powerful solution for clinicalresearchers. By integrating SAS with robust QC methodologies, clinical trials can achieve higher standards of accuracy and compliance.
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. Clinicalresearch is grounded in scientific integrity, participant safety, and data reliability.
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.
Global expertise and 7 key lessons learned The PPD clinicalresearch 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.
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.
Efficient and compliant data capture can make or break the success of a clinicalresearch 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.
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent).
Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinicalresearch 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.,
To protect human subjects in clinicalresearch, 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)? .
However, some industries like healthcare and clinicalresearch 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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