XTalks
MARCH 6, 2023
Levation Pharma has initiated a Phase I/II trial to evaluate the preliminary safety and potential efficacy of their investigational topical gel LEV102 for acquired blepharoptosis in adults. This is the first clinical trial that the company has launched for LEV102.
Pharma Phorum
JANUARY 14, 2022
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.
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Pharma Phorum
AUGUST 6, 2021
Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment.
XTalks
NOVEMBER 7, 2022
Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials.
Crucial Data Soutions
DECEMBER 15, 2020
Someday, clinical and post-market research will be 100 percent remote. But in fact, ‘someday’ in the clinical research space is now. A medical device sponsor is conducting a clinical trial on an innovative cardiac stent.
Pharmaceutical Technology
AUGUST 24, 2022
Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. This helps sponsors identify patients for clinical trials, as well as helps clinicians devise patient-specific treatment plans for participants.
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. Safety Management Ensuring patient safety is of paramount importance in clinical trials.
CATO Research
JULY 20, 2020
The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.
Pharma Phorum
JUNE 14, 2022
Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. Emphasising multiregional trials.
Riverside Clinical Research
MARCH 14, 2022
If you think you do, you may qualify for participation in clinical research that could be beneficial to you. How to Learn More or Begin this Clinical Study Volunteering Process . About Velocity Clinical Research. Study Information.
Pharma Phorum
JANUARY 27, 2023
Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said.
Pharma Phorum
JANUARY 27, 2023
The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. The impact of burnout on clinical trials Each staff member involved in a clinical trial is essential to its success.
CATO Research
JUNE 15, 2021
The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors.
Riverside Clinical Research
OCTOBER 10, 2022
Fatty acids which are contained in salmon and packed into flax seeds help protect and renew tissue, increasing brain function. Dark chocolate contains antioxidants and theobromine, which can improve focus, concentration and mood.
Pharma Phorum
MAY 5, 2022
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Increase the amount of useful clinical data.
XTalks
NOVEMBER 29, 2022
One of these cancer advocates is Devon Adams, an ACS CAN staff member with diverse policy and clinical experience. Can you tell us about the work you have done on the topic of decentralized clinical trials (DCTs) as a Senior Analyst for Policy and Legislative Support at the ACS CAN?
The Pharma Data
MARCH 31, 2022
A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. director of the Hope Clinic at the Emory Vaccine Center in Atlanta, and Angela Branche, M.D.,
The Pharma Data
JUNE 26, 2021
Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus.
The Pharma Data
JUNE 25, 2022
Primary vaccination with Beta-containing vaccine candidate delivers 64.7% in seropositives Favorable safety and tolerability profile First ever reported efficacy data in an Omicron environment support relevance of a Beta-containing vaccine.
The Pharma Data
JULY 8, 2021
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).
XTalks
FEBRUARY 7, 2023
Rugo, MD, professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, US and principal investigator of the TROPiCS-02 study, in the press release.
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 conduct and .
The Pharma Data
APRIL 3, 2021
No serious safety signals were raised in the trial. Analyses remain ongoing and NIAID and the INSIGHT Network intend to publish the full results of the trial soon. ” Following the outcome of the ITAC trial, the CoVIg-19 Plasma Alliance’s work now concludes. Clinical Trail
Riverside Clinical Research
MARCH 2, 2020
Hot flashes are commonly caused by certain foods and drinks – particularly spicy food, food or drinks containing caffeine and alcoholic beverages; medication side effects; stress; smoking; and even tight clothing.
The Pharma Data
JANUARY 17, 2021
The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.
The Pharma Data
JANUARY 10, 2021
There were no serious adverse events related to treatment and no clinically significant injection site reactions. Because ASLAN004 is the only clinical stage monoclonal antibody targeting IL-13R?1, This release contains forward-looking statements.
The Pharma Data
SEPTEMBER 25, 2020
Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate.
The Pharma Data
OCTOBER 19, 2020
“We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. Phase 2 trial for Berubicin during the first quarter of 2021.”
The Pharma Data
OCTOBER 25, 2020
NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. .
The Pharma Data
JANUARY 13, 2021
Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. . NEW YORK , Jan.
Pharma Phorum
DECEMBER 13, 2022
Over the past few years, many clinical study administrators wanted to use the bring your own device (BYOD) model within their eCOA, but they were typically constrained by regulatory requirements or misunderstandings around the approach. BYOD in clinical trials.
The Pharma Data
SEPTEMBER 23, 2020
September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. NEW BRUNSWICK, N.J.,
The Pharma Data
JANUARY 25, 2021
agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Cessation will be measured and determined by clinical and EEG findings. About the RAISE Trial. 26, 2021 12:01 UTC. Marinus and Ceribell, Inc.
CATO Research
JUNE 29, 2020
The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials. This resulted in higher costs for sponsors and long trial start-up timelines. The number of newly registered clinical trials per year in Europe is declining in the past decade.
Pharma Phorum
AUGUST 31, 2021
ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. It is no surprise that total per patient costs exceed $100,000 in most oncology trials, with haematology patients costing multiples of that.
XTalks
MAY 24, 2022
There has been a lengthy search to find an HIV cure and there have been a few promising trials, including the stem cell transplantation reported at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI-2022). Clinical Trials of Lenacapavir.
Cloudbyz
MAY 22, 2020
If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. 3) Objectives & Purpose : This section contains a detailed description of primary and secondary objectives.
The Pharma Data
NOVEMBER 18, 2021
At the recommendation of the eDMC, Merck is stopping dosing in the trial, with continued monitoring of study participants. All clinical studies provide important learnings to help us in the fight against HIV, and we are grateful to the patients and investigators for their contributions.”.
The Pharma Data
JANUARY 3, 2021
United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency. U.S.
The Pharma Data
NOVEMBER 14, 2020
In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate for the prevention of COVID-19 in up to 30,000 participants worldwide. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. Clinical Trails
Pharma Phorum
SEPTEMBER 15, 2022
The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. This enables regulatory reviewers to evaluate and process clinical trials more effectively.
The Pharma Data
JANUARY 6, 2021
Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% EMERYVILLE, Calif. ,
XTalks
APRIL 29, 2022
Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo.
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