PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. At the end of 2022, the PPD clinical research business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinical trial execution across the industry.

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Clinical Trials Trials Clinical Research FDA 98

Drug Discovery World

JANUARY 25, 2023

Tom Brazier , Director Decentralised Clinical Trials, mdgroup and Stephanie Larimer, Q² Solutions discuss the opportunities for decentralised clinical trials and how common pitfalls can be avoided through communications and streamlined working. The market, worth an estimated $8.8 billion, by 2026 1.

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PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. The increase in complexity isn’t just creating challenges for patients.

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Clinical Trials Trials Clinical Research Research 52

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.

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Clinical Trials Trials Compliance Clinical Research 52

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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Clinical Trials Regulations Trials Pharmaceutical Companies 52

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinical research landscape.

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Clinical Trials Trials Clinical Research Research 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Clinical Trials Trials Clinical Research Disease 59

Drug Discovery World

JUNE 20, 2024

Deepika Khedekar investigates the use of LLMs in clinical trials and how we can overcome the potential challenges to their wider application. Clinical trials make up a large part of this investment, and yet 95% of them fail 2. A single phase III clinical trial can rack up to 3.56 million data points 5.

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Clinical Research Research Clinical Trials Trials 147

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

Conversations in Drug Development Trends

APRIL 8, 2024

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success.

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Clinical Trials Clinical Research Trials Compliance 75

On Medicine

FEBRUARY 8, 2024

Why is the CHARMER trial important? The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards. We have five public and patient involvement members working on the study, with their focus on providing input into patient-facing documents and processes.

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Hospitals Doctors Trials Clinical Research 109

Quanticate

MAY 21, 2020

This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation. There are two main areas in medical writing, medical communications and regulatory writing.

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Clinical Research Research Clinical Trials FDA 52

Advarra

JUNE 16, 2022

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. Budget negotiation .

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H1 Blog

MAY 18, 2023

Streamline your operations and improve trial feasibility and outcomes. Clinical Research Organizations (CROs) play an important role in the success of clinical trials. CROs can help improve trial site feasibility and success by increasing recruitment and boosting diversity among study participants.

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Clinical Trials Trials Clinical Research Research 52

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Regulations Trials Science Clinical Trials 40

Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

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Clinical Trials Trials FDA Clinical Research 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.,

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Clinical Trials Research Trials 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.

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Compliance Clinical Research Clinical Trials Trials 52

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows).

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Licensing Licensing Pharmacy FDA 52

Vial

DECEMBER 11, 2023

Despite the essential role of the clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. Overview of key clinical trial milestones during start-up. weeks for Phase II and Phase III studies.

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Clinical Trials Clinical Research Trials Research 52

Advarra

FEBRUARY 14, 2024

With trial complexity increasing, site staff availability stretched thin, bespoke methods of interaction, and unique methods of engaging with patients administered by sites, the relationship is complicated. Is Your Trial Designed to Leverage Site-provided Information?

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Trials Nurses FDA Clinical Trials 52

Olympian Clinical Research

JUNE 27, 2023

Keeping a Food Journal: Document your meals and any corresponding skin changes to identify trigger foods. Engage in Adult Eczema Clinical Research with Olympian Clinical Research Seek additional assistance for your adult eczema by participating in a clinical research study at Olympian Clinical Research.

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Clinical Research Packaging Doctors Production 52

Advarra

NOVEMBER 9, 2023

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. Understanding Study Startup Activities Study startup is the phase of a clinical trial occurring after the protocol development and regulatory approval stages.

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Compliance Clinical Trials Trials Research 52

Drug Discovery World

OCTOBER 12, 2022

10-15 years ago, there were few validated medical devices for clinical research, and now we have a lot of technology to choose from. Why are digital biomarkers important in clinical trials? . What are the challenges using sensors in clinical trials? How does Sensor Cloud address this? . About the author .

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Clinical Trials Trials Disease Clinical Research 130

Agency IQ

AUGUST 30, 2024

many types of clinical research must comply with regulations intended to protect the rights of research participants. While the FDA regulates the conduct of clinical trials which evaluate medical products , its parent department, HHS oversees the conduct of all studies that involve human subjects.

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Advarra

MAY 25, 2022

Compliant, efficient document management during the various phases of a clinical trial is essential. As clinical research continues to move towards a remote environment, centralizing and integrating your regulatory management process and technology is vital to your institution’s success. Current eReg Integrations.

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Compliance Clinical Trials Trials Research 52

Vial

MAY 8, 2024

The widespread adoption of EDC technology has revolutionized clinical operations , offering benefits such as improved data management, reduced trial timelines, remote monitoring capabilities, and enhanced data security. EDC is a system used in clinical trials to electronically record and manage subject data.

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Clinical Trials Trials Clinical Research Laboratories 52

Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. Typically used for investigator-initiated trials (IITs), EDC is used for transcribing paper source into an application, with a team providing downstream analysis for endpoint adjudication and data submission.

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Compliance Clinical Research Trials FDA 52

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

Advarra

OCTOBER 6, 2022

Whether they’re recorded on paper or electronically, source data should follow ALCOA-C, an acronym used in clinical research for: . If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. . Attributable . Contemporaneous . Original . Accurate .

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Compliance Clinical Trials Trials Clinical Research 52

Olympian Clinical Research

APRIL 28, 2021

It’s not uncommon for fibromyalgia to co-exist with conditions like IBS, chronic fatigue syndrome, migraines, interstitial cystitis, or even anxiety and depression, so it’s important for patients to document all of their symptoms and share that information with their doctor before determining a treatment plan. .

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Clinical Research Clinical Trials Doctors Treatment 52

Crucial Data Solutions

MARCH 30, 2023

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. EDC, as can be ascertained from the name, involves collecting clinical research data electronically or digitally. Yet, this is not the case.

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Clinical Trials Trials Clinical Research Research 52

Drug Discovery World

JULY 25, 2023

It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. Ethical considerations Given the vulnerable status of children, safeguards are needed when including a paediatric population in clinical investigations of drugs and medical devices.

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Olympian Clinical Research

NOVEMBER 6, 2023

Smoking: Cigarette smoking is a well-documented trigger and worsening factor for HS. Contribute to Hidradenitis Suppurativa Breakthroughs At Olympian Clinical Research, we’re passionate about making a difference for those with HS. You can contribute to this essential work by participating in our clinical trials.

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Clinical Trials Doctors Clinical Research Treatment 52

Advarra

JANUARY 10, 2023

As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. Clinical research staff time is incredibly valuable, and team members are constantly juggling multiple tasks at any given time. eConsent Gives Sites Flexibility.

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Clinical Trials Clinical Research Trials Research 52

Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. Thorough product characterisation analysis plays a pivotal role in this process, ensuring that we can provide a comprehensive and well-documented account of our therapies.

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Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. As AgencyIQ discussed in-depth at the time , the committee grappled with data flaws and gaps within the context of positive trials and high unmet need.

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