Fierce BioTech

OCTOBER 2, 2023

Logistics For Cell & Gene Therapy Trials: Specific Needs Demand Special Skills Download now to learn more about intricate trial logistics, the importance of expertise, navigating regulations, secure data management, and real case studies like viral vector therapy for Spinal Muscular Atrophy. A specialized provider is essential.

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The Pharma Data

NOVEMBER 26, 2020

Download Your Copy. We respect your privacy, by clicking “Download Your Copy” you agree to having your details passed onto the sponsor who may promote similar products and services related to your area of interest subject to their privacy policy. Download Your Copy. . Download Your Copy.

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PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Common Sense for Drug Policy Blog

MARCH 11, 2025

Former Philippine President Duterte Arrested And Flown To The Hague For Trial Former Philippine President Rodrigo Duterte was arrested Tuesday, March 11, 2025 on a warrant from the International Criminal Court. A copy of the International Criminal Court warrant for Duterte's arrest can be downloaded from the ICC website.

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Fierce BioTech

NOVEMBER 2, 2023

Optimizing Clinical Trials: Getting the Right Results by Keeping it Real Discover how RWD can transform your approach to clinical trial protocol optimization, patient identification, and site selection in this survey of clinical research leaders by Flatiron Health. Download now.

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Fierce BioTech

OCTOBER 3, 2023

Addressing Hidden Patient Populations During Clinical Trials Using Predictive Intelligence By directly engaging with physicians and their care teams, researchers are better positioned to find the right patients – and build a cohort more representative of the general population. Download here!

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Conversations in Drug Development Trends

SEPTEMBER 20, 2023

Download our poster today. The post Bioanalysis through automation: Our top four takeaways appeared first on Worldwide Clinical Trials. Time Savings: With the increased quality and throughput, we can validate assays in just a few days as opposed to weeks.   Want to learn exactly how we did it?

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Fierce BioTech

JULY 28, 2023

State of Clinical Inventory and Sample Management for Clinical Trials This report summarizes the survey findings from biopharma professionals on the impacts of inefficient, manual processes for managing clinical supply and samples on budgets, timelines, data integrity, and patients — and the need for change. Download here!

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Alta Sciences

APRIL 17, 2024

Planning a First-In-Human Clinical Trial? blussier Wed, 04/17/2024 - 20:52 HTML Unique FIH Solutions for Small and Large Molecules Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. DOWNLOAD Speak with one of our experts. Access the eBook here to learn more.

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PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinical trials  (DCTs) continue to expand and have become a standard solution for drug developers.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs 1.

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PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget. This year, the U.S.

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Crucial Data Solutions

MAY 31, 2023

Clinical trials continue to move closer to patients. Many patients, now, can participate fully in clinical trials largely from home by utilizing remote data collection technologies such as ePRO, eConsent, virtual visits, and more. They do so, largely, from mobile devices – often their very own smartphones.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX: CALTX) (NASDAQ: CALT) today announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy (IgAN).

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Fierce BioTech

MAY 30, 2024

Quantify Cancer With Methylation-Based ctDNA Detection Download this resource to accelerate your oncology clinical trials, optimize patient enrollment, and monitor minimal residual disease and molecular response effectively.

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The Pharma Data

OCTOBER 19, 2020

We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.” In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. .

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Fierce BioTech

MAY 31, 2024

Generative AI: Powering the next era of life sciences innovations Download this eBook to explore how generative AI is revolutionizing life sciences. Learn to accelerate drug discovery through AI-powered protein folding, enhance clinical trials with data analysis, and optimize manufacturing with real-time AI monitoring.

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The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ –: iSTAR Medical , a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIject TM. WAVRE, Belgium , Nov.

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The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

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The Pharma Data

JANUARY 12, 2021

a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor. .

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The Pharma Data

DECEMBER 8, 2020

Download Your Copy. We respect your privacy, by clicking “Download Your Copy” you agree to having your details passed onto the sponsor who may promote similar products and services related to your area of interest subject to their privacy policy. . Download Your Copy. . Download Your Copy.

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The ChEMBL-og

APRIL 16, 2024

See [link] and INN clinical candidate drugs (assigned as max_phase = 2 based on INN guidance that states “As a general guide, the development of a drug should progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection.”

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Perficient: Drug Development

AUGUST 2, 2023

For learning purposes, you can request a trial license as well. Purchase/Trial Sitecore TDS and SVS license Step 01: Goto the TDS site Step 02: Click on the Free Trial link Step 03: Click the Try TDS button Step 04: Submit the TDS free trial form. Step 05: After submission, you need to download a package and install it.

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The Pharma Data

DECEMBER 14, 2020

The Phase II SBIR grant is a follow-on 2–year award that will support testing of Alume’s fluorescent nerve targeting agent in an ongoing Phase 1/2 clinical trial in patients undergoing Head and Neck Surgery. View original content to download multimedia: [link]. About Alume Biosciences, Inc. SOURCE Alume Biosciences.

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Conversations in Drug Development Trends

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. Download our full poster to explore the comprehensive analysis and our findings and to discover how DNA sample collection can impact the effectiveness of personalized medicine.

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Predictive Oncology

AUGUST 8, 2024

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.

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Fierce BioTech

JANUARY 26, 2024

Blueprint for Modern Patient Recruitment Every day, a clinical trial is delayed due to recruitment planning issues. Discover how leading sponsors are redefining the approach to patient recruitment in clinical trials. Download now. Download now.

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The Pharma Data

DECEMBER 20, 2020

Followed by Russia , Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy on Friday, December 18, 2020. Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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The Pharma Data

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. View original content to download multimedia: [link]. BARCELONA, Spain , Jan. BARCELONA, Spain , Jan.

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . View original content to download multimedia: [link]. “Results from this study, which we are calling SWARM- P.a.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. View original content to download multimedia: [link].

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Fierce BioTech

AUGUST 1, 2023

Support for the next generation of clinical and IVD trials requires a unique, multi-specialty approach. Download here! Support for the next generation of clinical and IVD trials requires a unique, multi-specialty approach. However, these modalities add significant complexity to pharma and biotech research projects.

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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. Per the CTR, all clinical trials are to be moved over to the CTIS by January 30, 2025.

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