Cloudbyz

JUNE 19, 2023

Large language models excel in understanding and contextualizing textual data, enabling efficient adverse event detection and categorization. Improving Risk Assessment: Generative AI models can contribute to better risk assessment by leveraging large-scale data to identify factors associated with increased risk.

Drugs 76

Drugs Compliance Clinical Trials Clinical Trials 76

ACRP blog

AUGUST 2, 2023

Leverage data and technology to optimize participant recruitment, enrollment, and retention. WCG partners with research sites to provide comprehensive, integrated solutions designed to address the primary challenges sites face in effectively launching, managing, and growing a research program.

Trials 52

Trials Clinical Research Clinical Trials Clinical Trials 52

ACRP blog

AUGUST 2, 2023

Leverage data and technology to optimize participant recruitment, enrollment, and retention. WCG partners with research sites to provide comprehensive, integrated solutions designed to address the primary challenges sites face in effectively launching, managing, and growing a research program.

Trials 52

Trials Clinical Research Clinical Trials Clinical Trials 52

pharmaphorum

MAY 26, 2022

Automatization may be a solution. Now those companies who have turned to automatic solutions keep it up. One of those essential but not yet digitized stages in pharmacovigilance was medical literature monitoring. . On average, a specialist should spend about 40 hours per week monitoring 100 sources. .

Drugs 52

Drugs Production Marketing Medicine 52

Clinical Trial Podcast

FEBRUARY 23, 2021

After mapping out trial assumptions such as number of sites, patients, enrollment period, monitoring, a project manager will develop the study budget and timeline with key milestones. During a periodic data review meeting, the project manager finds out that the site has a significant number of protocol deviations.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

XTalks

JANUARY 4, 2024

This achievement now allows the company to start clinical trials in the US, including a Phase II study for primary open-angle glaucoma (OAG) or ocular hypertension (OHT), with data expected in early 2024. Furthermore, in 2022, Thea Pharma’s Iyuzeh (latanoprost ophthalmic solution) 0.005 percent was granted FDA approval for IOP reduction.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

Advarra

JUNE 16, 2022

These elements are most critical and demand the most attention from sponsors, contract research organizations (CROs), monitors, and sites. . Collecting, storing, and submitting the data and documents associated with the trial . Collecting data during the visit . Do you need a data monitoring committee? .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

JANUARY 13, 2021

Some of the standard buckets are technology, travel and meeting costs, data management support, manpower cost, study intervention, study-related care, etc. Remember that every task and data point will cost you money , so allocate them in your budget. There are overhead costs too, that needs to be budgeted.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

Worldwide Clinical Trials

JUNE 15, 2022

But it’s important we strive to find ways to include diverse patients so trial data can be representative of the wider population. This data is important for informing the safety of an investigational product and will only be found if we continue to increase the diversity of clinical trials.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

Trialfacts

NOVEMBER 12, 2023

47257 Fremont Blvd, Fremont, CA 94538, United States Lead Researcher: Dr. Grace Gardner IRB Committee: This study has been reviewed and approved by the WCG Institutional Review Board About the Study Did you know that approximately 1 in 7 people living in the United States have hearing loss? Location: Sonova USA, Inc., Who Can Participate?

Branding 52

Branding Research Licensing Licensing 52

The Pharma Data

OCTOBER 26, 2020

Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody. Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. Please read more here. . portion of the study. Typically, the U.S.

Antibody 52

Antibody Vaccination Vaccine Manufacturing 52

Cloudbyz

JANUARY 13, 2021

Some of the standard buckets are technology, travel and meeting costs, data management support, manpower cost, study intervention, study-related care, etc. Remember that every task and data point will cost you money, so allocate them in your budget. There are overhead costs too, that needs to be budgeted. Wrapping Up.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

XTalks

JULY 19, 2022

Analysis of clinical trial data for Novavax’s COVID-19 vaccine showed that the shot was over 90 percent effective in preventing all forms/severities of COVID-19, from mild to severe. Safety data came from about 26,000 clinical trial participants who were administered the vaccine and 25,000 who received placebo. The vaccine was 78.6

Vaccination 94

Vaccination Vaccine Protein Clinical Trials 94

Cloudbyz

JUNE 13, 2023

Data Management and Analysis: Effective data management and analysis are vital for clinical trial success. Budgets should incorporate costs related to data collection, data management systems, database setup, monitoring, statistical analysis, and reporting.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Marketing 69

pharmaphorum

APRIL 27, 2022

Redefining HCP engagement monitoring. I don’t know’ ” As the pandemic progressed, it quickly became clear that identifying and measuring omnichannel marketing success would require companies to think outside of the box and develop solutions that effectively addressed the unique needs of modern marketing.

Marketing 115

Marketing Sales Production Development 115

Delveinsight

AUGUST 24, 2021

So, the Independent Data Monitoring Committee (IDMC) recommended halting the clinical trials for future purposes. The data collected after the study remained constant with no new progressive achievement. Approval of 2 formulations was granted, one a tablet and the other an oral solution with weight-based dosage.

Clinical Trials 96

Clinical Trials Clinical Trials Trials Drugs 96

Pfizer

APRIL 14, 2023

This week we are approaching another pivotal moment in our ongoing fight against the virus as an independent advisory committee will meet to discuss and advise the FDA on Pfizer’s application seeking approval of a booster dose of our COVID-19 vaccine in people ages 16 years and older. With more than 1.5

Vaccination 52

Vaccination Vaccine Immune Response Clinical Trials 52

Pharmaceutical Technology

OCTOBER 28, 2022

According to Alex Edwards, solutions architect at leading pharmaceutical translations provider RWS: “Pharma companies have three years until EU-CTR is mandatory, but it's in everyone's interest to start sooner rather than later. This introduction of tighter deadlines has become a key pain point for sponsors. “In

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Clinical Trials Clinical Trials Life Science Trials 130

The Pharma Data

APRIL 8, 2021

Phase 3 Data from KEYNOTE-564 to be Presented at Upcoming Medical Meeting and Submitted to Regulatory Authorities. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo.

Trials 52

Trials Clinical Development Antibody Clinical Research 52

XTalks

FEBRUARY 22, 2024

The shift to full approval was supported by data from an additional 161 patients and 28 more months of monitoring to evaluate DOR. The main criteria for effectiveness were ORR and DOR, as assessed by a blinded independent review committee.

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

Pfizer

OCTOBER 28, 2022

NYSE: PFE) announced today that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded their assessment of Janus kinase (JAK) inhibitors authorized for the treatment of certain inflammatory diseases in the European Union (EU) and has provided updated recommendations for their use.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

The Pharma Data

OCTOBER 6, 2021

Data from the early-stage study suggest that an antiviral compound prevents the interaction between two viral proteins (NS3 and NS4B) that play an important role in the replication process of a virus, thereby stopping the ability of the virus to reproduce. Janssen is now moving its dengue program into clinical development.

Clinical Development 52

Clinical Development Development Research Licensing 52

The Pharma Data

MARCH 22, 2021

Regeneron will share new data with the U.S. Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19. in the 2,400 mg group and 4.0%

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

JULY 23, 2021

In addition, data from preclinical studies, as referenced in publications in Cell and Nature, showed that casirivimab and imdevimab retained neutralisation activity against key emerging variants. Since then, we have continued to add a range of diagnostics solutions to our global portfolio to help in the fight against COVID-19.

Antibody 52

Antibody Medicine Production In-Vitro 52

Pfizer

NOVEMBER 2, 2022

The data will also provide us with more insights on the potential of mRNA vaccines addressing more than one pathogen. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

MARCH 18, 2021

We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial.

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52

pharmaphorum

JANUARY 11, 2021

From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. There is no shortage of online conference solutions available, but there is still much to improve on.

Clinical Trials 78

Clinical Trials Clinical Trials Life Science Containment 78

The Pharma Data

MARCH 2, 2021

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021. Efficacy was consistent across age, gender, race and ethnicity demographics.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 1, 2020

will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI). The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”. This press release features multimedia.

Vaccination 40

Vaccination Vaccine Manufacturing Clinical Trials 40

XTalks

AUGUST 30, 2022

The accelerated approval was based on data from clinical trials that showed aducanumab can reduce brain amyloid beta plaques, which are biomarkers in Alzheimer’s disease that are likely to predict clinical benefit. Figure 3 ). ICV delivery is always done under general anesthesia and this needs to be considered when selecting participants.

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Trials Drug Delivery Drugs Gene 83

The Pharma Data

OCTOBER 21, 2020

Clinical study data suggests Tyvaso® improved forced vital capacity, an important measure of lung function, in patients with pulmonary hypertension associated with interstitial lung disease. The data were featured in one of seven abstracts sponsored by United Therapeutics at the conference. SILVER SPRING, Md.

Production 52

Production Drugs Containment Bioinformatics 52

Advarra

JULY 19, 2022

Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities. They may include key performance indicators (KPI) and key risk indicators (KRIs) to monitor vendor performance. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

Packaging 52

Packaging Packaging Drugs Containment 52

Drug Discovery World

FEBRUARY 20, 2024

To address the latter, digital solutions such as eConsent are replacing paper ICFs which streamline the process to a more patient-centric approach. Despite the benefits described above, eConsent solutions are based on an isolated user identity model for participant identity management. for sponsors or sites, or private, eg.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Pharma Companies 52

Drug Discovery World

FEBRUARY 20, 2024

To address the latter, as shown in Figure 2, digital solutions such as eConsent are replacing paper ICFs which streamline the process to a more patient-centric approach. Despite the benefits described above, eConsent solutions are based on an isolated user identity model for participant identity management.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Pharma Companies 52

The Pharma Data

JUNE 18, 2021

The data were presented for the first time today during the virtual 26 th European Hematology Association (EHA) Annual Congress (abstract #S146). Efficacy was based on PFS as assessed by an independent review committee. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.

Medicine 40

Medicine HR Trials Production 40

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About VIR-7831 / GSK4182136.

Antibody 52

Antibody Trials Vaccination Vaccine 52