Contract research organization

Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia

Retrieved on:

tisdag, maj 7, 2024

This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.

Key Points:

This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion.
An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated.
"Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical.
Michael Redmond, President of Oragenics, added, "Our collaboration with Avance Clinical during the Phase I trial was instrumental, and we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion."

Gentronix Recognised With King’s Award After Record International Growth

Retrieved on:

tisdag, maj 7, 2024

UK-based Contract Research Organisation (CRO) Gentronix – a leading specialist toxicology firm based at Alderley Park – has been awarded the King’s Award for Enterprise after achieving a triple-figure revenue growth following rapid expansion in international markets.

Key Points:

UK-based Contract Research Organisation (CRO) Gentronix – a leading specialist toxicology firm based at Alderley Park – has been awarded the King’s Award for Enterprise after achieving a triple-figure revenue growth following rapid expansion in international markets.
View the full release here: https://www.businesswire.com/news/home/20240507716487/en/
Gentronix Recognised With King’s Award After Record International Growth (Photo: Business Wire)
Gentronix recorded total growth of 239% in overseas earnings over the past three years, with the percentage of total sales exported rising from 71% to 81% over the same period, driving revenue to in excess of £10m per annum.
The US has been a particularly strong area of growth and this market now makes up almost half of the firm’s international business, with demand continuing to increase across North America.
As a result of the business’s success and enhanced overseas trading, Gentronix has received a prestigious King’s Award for Enterprise for 2024, marking its success in the area of International Trade.

MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating

Retrieved on:

tisdag, maj 7, 2024

FDA, Safety, Food, De novo, Documentation, Spine, Support, Food and Drug Administration, MCRA, Health, Contract research organization, Pharmaceutical industry

WASHINGTON, May 7, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and healthcare advisory firm is proud to announce its role in supporting Orthobond with achieving a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System with Ostaguard™ coating. This De Novo grant marks the first spine device to be treated with a coating that reduces bacterial contamination in the operating room.

Key Points:

This De Novo grant marks the first spine device to be treated with a coating that reduces bacterial contamination in the operating room.
MCRA Responsible for Regulatory Strategy and Support for FDA Submission for Orthobond's Ostaguard.
Orthobond engaged MCRA in March 2020 to help support their pre-submission efforts in gaining FDA feedback to their proposed performance testing suite for their Ostaguard antibacterial technology.
On April 5th, the FDA granted the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial use.

KCAS Bio and Crux Biolabs Announce Global Spectral Flow Cytometry Alliance

Retrieved on:

fredag, maj 3, 2024

Research, Clinical Trials, Health Technology, Stem Cells, Biotechnology, Health, Pharmaceutical, General Health, Science, Contract research organization, Vitruvian Partners, Partnership, Investment, Partner, Flow cytometry

KCAS Bio has partnered with Crux Biolabs, a leading provider of flow cytometry and bioanalytical services located in Melbourne, Australia.

Key Points:

KCAS Bio has partnered with Crux Biolabs, a leading provider of flow cytometry and bioanalytical services located in Melbourne, Australia.
John Bucksath, CEO of KCAS Bio, commented, “We are delighted to partner with the Crux Biolabs team, working to accelerate our combined offering of global development support to the industries and customers we serve.
KCAS Bio has embarked on significant investments in spectral flow cytometry, including the placement of harmonized Cytek Aurora cytometers at Crux Biolabs.
Establishing common practices and using a harmonized Cytek Aurora platform for spectral flow cytometry with KCAS Bio will bring a unique and industry-leading offering to our current and emerging clients.”

Ephicacy Consulting Group Completes Acquisition of Advance Research Associates

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torsdag, maj 2, 2024

Technology, Medical Devices, Consulting, Clinical Trials, Professional Services, Biometrics, Biotechnology, Pharmaceutical, Health, Data Management, Contract research organization, ARA, Biostatistics, Patient, Acquisition, Associate, Data management, Pharmaceutical industry

Ephicacy Consulting Group, Inc. (“Ephicacy”), a leading biometrics Contract Research Organization (“CRO”), today announced that it has acquired Advance Research Associates (“ARA”), a provider of data management and biostatistical consulting services for clinical trials.

Key Points:

Ephicacy Consulting Group, Inc. (“Ephicacy”), a leading biometrics Contract Research Organization (“CRO”), today announced that it has acquired Advance Research Associates (“ARA”), a provider of data management and biostatistical consulting services for clinical trials.
Since its founding in 2005, Ephicacy has grown into a leading biometrics Contract Research Organization (“CRO”) leveraging its global talent pool to deliver clinical analytics services.
“It is ARA’s mission to consistently provide the highest quality customized data management and biostatistical consulting services to our clients.
Joining forces with Ephicacy represents a natural evolution of that mission,” said Peter Shabe, ARA Founder and Ephicacy’s incoming Global Head of Biostatistics Consulting.

MCRA Supports Darmiyan with FDA Approval for BrainSee Device

Retrieved on:

torsdag, maj 2, 2024

Alzheimer's disease, FDA, Brain, MCI, Policy, Food, Montreal Cognitive Assessment, De novo, Artificial intelligence, Digital, Science, Digital health, MCRA, MRI, Marketing, Contract research organization, Pharmaceutical industry

MCRA announces its role in the successful granting of Darmiyan's De Novo request for BrainSee by the FDA.

Key Points:

MCRA announces its role in the successful granting of Darmiyan's De Novo request for BrainSee by the FDA.
Darmiyan retained MCRA in 2021 for its broad and deep experience in Neurology, Digital Health, and Artificial Intelligence (AI).
John Doucet, Vice President, Neurology Regulatory Affairs – Neuromodulation and Evolving Technologies at MCRA states, "We are proud to have worked closely with Darmiyan to achieve both Breakthrough Device Designation and marketing authorization from the FDA for BrainSee.
The FDA Breakthrough Device Designation for BrainSee was a critical foundation for FDA collaborations during development, review, and granting of the De Novo request.

Novotech Appoints Commercial and Clinical Life Sciences Specialist to Head Up Global Drug Development Consulting Team

Retrieved on:

torsdag, maj 2, 2024

Contract research organization, University, Probability, Public health, DDC, Vaccine, Therapy, CMC, Drug development, Antibody, Toxicology

BOSTON, May 02, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has appointed Scott Schliebner as Vice President and Global Head, Drug Development Consulting (DDC) .

Key Points:

BOSTON, May 02, 2024 (GLOBE NEWSWIRE) -- Novotech , the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has appointed Scott Schliebner as Vice President and Global Head, Drug Development Consulting (DDC) .
He is a proven strategic, innovative, and business focused life sciences executive with ~30 year of experience across the biopharma and CRO sectors.
To do this, DDC leverages CMC/manufacturing, toxicology, clinical/medical and regulatory affairs experts with extensive industry experience covering all phases of drug development.
I am also passionate about leveraging data and technology including RWE/RWD, technological innovation, and patient-focused paradigms to accelerate clinical drug development,” he said.

ASLAN Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on:

fredag, april 12, 2024

Cash used in operations for the fourth quarter of 2023 was $7.6 million compared to $12.0 million in the same period in 2022.

Key Points:

Cash used in operations for the fourth quarter of 2023 was $7.6 million compared to $12.0 million in the same period in 2022.
Research and development expenses were $9.6 million in the fourth quarter of 2023 compared to $10.7 million in the fourth quarter of 2022.
General and administrative expenses were $3.2 million in the fourth quarter of 2023 compared to $2.7 million in the fourth quarter of 2022.
Net loss attributable to stockholders for the fourth quarter of 2023 was $13.5 million compared to a net loss of $14.5 million for the fourth quarter of 2022.

Innovaderm, Recognized by Clinical Leaders CRO Leadership Awards for the 4th Consecutive Year

Retrieved on:

onsdag, maj 1, 2024

Health, Biometrics, Clinical Trials, Research, Pharmaceutical, Science, Contract research organization, Overalls, Dermatology, ISR, Fine chemical

Innovaderm , the leading medical dermatology and aesthetics Contract Research Organization (CRO), today announced that it has been selected by Clinical Leaders CRO Leadership Awards for the fourth consecutive year, excelling across core categories of Expertise, Capabilities, Quality, and Reliability.

Key Points:

Innovaderm , the leading medical dermatology and aesthetics Contract Research Organization (CRO), today announced that it has been selected by Clinical Leaders CRO Leadership Awards for the fourth consecutive year, excelling across core categories of Expertise, Capabilities, Quality, and Reliability.
Clinical Leaders CRO Leadership Awards, which include a collaboration with ISR Reports, provide readers with accurate and reliable customer feedback to assist them in choosing a reputable CRO partner.
“We are proud to be recognized by the CRO Leadership Awards for the 4th year running,” said Cedric Burg, COO at Innovaderm.
The CRO’s comprehensive approach includes full-service capabilities and stand-alone biometrics and clinical regulatory services across all phases of clinical trials.

NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June

Retrieved on:

tisdag, april 30, 2024

Contract research organization, American Diabetes Association, GAN, Part, Congress, EASL, Gubra, OXM, Weight loss, GCGR, GLP1R, GPR119, Obesity, SAD, Glucagon-like peptide-1 receptor, MASH, Pharmaceutical industry

"We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Key Points:

"We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
DA-1726 has consistently shown, in our preclinical data, to sustain weight loss in diet-induced obese models by decreasing food consumption and boosting energy expenditure.
Both programs are progressing well, and we have been able to significantly accelerate the clinical timelines for DA-1726.
A member of the Dong-A ST Research Center will present pre-clinical data on DA-1726 in a poster presentation at this scientific session in Orlando, FL.