XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Cloudbyz

FEBRUARY 26, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports.

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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 release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra. “Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

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Cloudbyz

FEBRUARY 21, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial and proves that a clinical trial has been conducted following Good Clinical Practice (GCP) guidelines and all regulatory requirements and also demonstrates that the integrity of trial data has been maintained.

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Cloudbyz

JULY 11, 2022

Author: Reeshav Mittal , Associate Director, Clinical Operations, Cloudbyz Inc. What correspondence is considered relevant for a clinical trial? The DIA TMF Reference Model states that the following clinical trial correspondence is relevant : . trial administration, . trial conduct and . Agreements,

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WCG Clinical

JULY 12, 2023

The report provides a 360-degree review of what motivates or deters potential volunteers from participating in clinical trials, and what steps can be taken to encourage more participation, particularly among underrepresented groups. Avoca joined the WCG family of companies in April 2021.

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pharmaphorum

DECEMBER 13, 2022

The COVID-19 pandemic created an urgent need to reach out and connect with study participants without them coming into clinics and risking infection. This precipitated a shift from a centralised trial experience to a decentralised one, resulting in participants communicating electronically. BYOD in clinical trials.

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XTalks

APRIL 25, 2024

Read on to learn more about the groundbreaking devices and trials shaping the future of heart failure management, as detailed by Medpace’s experts in the field. The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial.

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Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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Pharma in Brief

MAY 29, 2023

Background A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. A CSP is intended to partly compensate innovators for time spent on research and on obtaining marketing authorization.

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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. with compliance required beginning January 25, 2018. 21 st Century Cures Act.

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Cloudbyz

MARCH 30, 2023

Ensure Compliance: Life sciences organizations are subject to various data protection regulations, including GDPR, HIPAA, and CCPA. eSource / EDC/ Electronic Health Records (EHRs): EHRs contain sensitive patient information, including medical history, test results, and personal information.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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FDA Law Blog

FEBRUARY 7, 2023

It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions. Part 814), and for conducting clinical trials (21 C.F.R.

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. 9. 10 Trends and Statistics for Clinical Trials in 2023 Several key trends in clinical trials have been shaping the landscape of the field this year.

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WCG Clinical

NOVEMBER 17, 2023

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. It is unknown when these changes would go into effect if they are ultimately adopted.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

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pharmaphorum

SEPTEMBER 2, 2020

In other words, it’s a mapping between each item on a form to its corresponding variable contained within the corresponding dataset. How can Formedix clinical trial automation software help? And you’ll have a much happier and more productive Clinical Dataset Administrator! That means you’ll have no compliancy worries!

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Clinical Trials Clinical Trials Trials Compliance 52

Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

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The Pharma Data

DECEMBER 11, 2020

The University of Oxford has regularly appeared in our updates since July 2020, as its team of researchers leads an ongoing clinical trial for the Covid-19 vaccine. Sensitech technology helps to ensure the container refrigeration units can deliver a temperature control within +/- 0.25-degrees

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WCG Clinical

NOVEMBER 20, 2023

Access WCG’s whitepaper “Is This an Interventional Clinical Trial or Observational Study? While this paper is oriented toward the two extremes of clinical trial and registry, the information is broadly applicable. While oriented to clinical trials, this information applies to all research studies.

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Cloudbyz

FEBRUARY 23, 2023

Clinical trials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinical trial operations and increase operational efficiency. CTMS helps to streamline clinical trial processes, from study planning to site selection, enrollment, monitoring, and data analysis.

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Camargo

NOVEMBER 11, 2020

The speed of the submission in January 2020 and approval in October 2020 was attributed to the retrospective testing of available tumor tissue samples from patients enrolled in three clinical trials that led to the accelerated approval of larotrectinib. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder. Ken Phelps.

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Cloudbyz

MAY 22, 2020

3) Objectives & Purpose : This section contains a detailed description of primary and secondary objectives. Also, any HIPAA and other regulatory and compliance measures must be stated with accuracy and supporting documentation. WHERE the study will take place. Explanations on the science behind the drug and the possible outcomes.

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The Pharma Data

JULY 21, 2021

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

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Delveinsight

JANUARY 5, 2021

Somatrogon is going to compete with already established Pfizer’s Genotropin , a recombinant human growth hormone, however, the latter one puts a burden on the patients due to its daily injections, which also leads to compliance issues in children. SMS) has collaborated with Mayo Clinic to fight the battle against infectious diseases.

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The Pharma Data

OCTOBER 18, 2020

AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. Cautionary Note Regarding Forward Looking Statements.

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The Pharma Data

DECEMBER 20, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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The Pharma Data

JULY 27, 2021

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

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The Pharma Data

DECEMBER 27, 2020

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures. Cowen served as the sole placement agent for each of the PIPE financings.

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Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

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pharmaphorum

FEBRUARY 11, 2022

Sun says Komodo’s Healthcare Map has been built over the last seven and a half years and contains so much information that can help identify and treat patients with rare diseases. It’s our representation of tracking the deidentified, which is important from a privacy and compliance point of view,” Sun says. “It

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pharmaphorum

MAY 5, 2022

Why CDISC standards should never be ignored in any clinical trial: The use of CDISC standards allows externals to understand clinical trial data FAST. This increases the amount of useful clinical data that can be derived from a single study. Enhance the interoperability of clinical research systems.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. He will be Chair of the Audit, Risk & Compliance Committee of Sandoz.

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The Pharma Data

DECEMBER 14, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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