Good clinical practice

Global Clinical Trial Management Systems (CTMS) Business Report 2024: Market to Reach $4.5 Billion by 2030, Growing at a CAGR of 14.5% from 2023 to 2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 18, 2024
General Health, Health, Clinical Trials, Clinical trial, International Council, Conditional sentence, GCP, Prevalence, Research, CTMS, ICH, Growth, Good clinical practice, Pharmaceutical industry

The "Clinical Trial Management Systems (CTMS) - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trial Management Systems (CTMS) - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.
  • The global market for Clinical Trial Management Systems (CTMS) is estimated at US$1.7 Billion in 2023 and is projected to reach US$4.5 Billion by 2030, growing at a CAGR of 14.5% from 2023 to 2030.
  • This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.
  • The growth in the Clinical Trial Management Systems market is driven by several factors.

New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Deliver 30% Savings, Halve Timelines and Cut Risk for Biotechs

Retrieved on: 
Tuesday, June 4, 2024
Communication, GCP, Regulation, Good clinical practice, ChromeOS, FDA, Frost, EMA, Drug development, BIO, MFDS, WAKE, Safety, TGA, Marketing, Fine chemical

Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:

Key Points: 
  • Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:
    - Regulatory Strategy Development: We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals.
  • - Liaison with Regulatory Authorities: We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
  • "Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies.
  • Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions, she said.

AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS

Retrieved on: 
Friday, June 28, 2024
EMA, Committee, Good clinical practice, Survival, ALS, Patient, Element, Guideline, Science, Safety, European Medicines Agency, CHMP, Euronext, Vaccine

AB Science intends to ask for re-examination on the basis of:

Key Points: 
  • AB Science intends to ask for re-examination on the basis of:
    1)   First and foremost, the urgent need for patients to have early access to a promising treatment.
  • 2)   The opportunity of having the dossier re-examined by new rapporteurs and by a Scientific Advisory Board.
  • AB Science highlights the difficulty of a conditional marketing authorization in ALS and cannot guarantee a positive outcome following this re-examination.
  • The subgroup analysis is the strict application of EMA guidance (EMA/CHMP/539146/2013), which is applicable to post hoc analysis and to registration with single pivotal study, thus resolving the objection regarding subgroup data.

Sapio Sciences Introduces Sapio GMP LIMS Offering Unmatched Flexibility for Unique Manufacturing Processes

Retrieved on: 
Tuesday, June 25, 2024
Data Management, Biotechnology, Technology, Manufacturing, Health, Health Technology, Other Science, Research, Other Manufacturing, Software, Science, Good, GLP, Data and information visualization, Food, GxP, QC, Good clinical practice, ELN, Face, COA, GMP, Good laboratory practice, Environmental monitoring, Documentation, LIMS, GCP, Laboratory, Medical device

Sapio Sciences , the science-aware™ lab informatics platform, today announced the Sapio GMP (Good Manufacturing Practice) LIMS for laboratories that require unparalleled flexibility to meet manufacturing compliance standards.

Key Points: 
  • Sapio Sciences , the science-aware™ lab informatics platform, today announced the Sapio GMP (Good Manufacturing Practice) LIMS for laboratories that require unparalleled flexibility to meet manufacturing compliance standards.
  • The new Sapio GMP LIMS solution addresses industry applications in biotechnology, pharmaceutical, clinical research and diagnostics, food and beverage, chemical, and environmental testing.
  • Built on Sapio Sciences' industry-leading lab informatics platform , the new GMP solution includes a quality control laboratory information management system (QC LIMS), environmental monitoring programs, and stability management .
  • “By adopting Sapio GMP LIMS, manufacturing laboratories can quickly integrate, configure, and automate their unique compliance requirements to the precise nature of their products, processes, and organization.

Nucleai and GoPath Diagnostics Announce Strategic Collaboration to Provide Integrated AI-powered Digital Pathology Solutions for Clinical Research and Diagnostic Applications

Retrieved on: 
Monday, April 8, 2024
Other Health, Software, Research, Pharmaceutical, Oncology, Technology, Artificial Intelligence, Genetics, Health Technology, Science, Biotechnology, Health, College, GCP, LMS, Algorithm, Prostate cancer, Case management, Good clinical laboratory practice, Partnership, LIMS, CLEP, Biomarker, GCLP, AI, CAP, Good clinical practice, IBD, Medicine, Workflow, CLIA, Pathology, Inflammatory bowel disease, Medical director, Medical device

Nucleai , a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, today announced a strategic collaboration with GoPath Diagnostics , a leading full-service digital pathology and molecular diagnostics laboratory.

Key Points: 
  • Nucleai , a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, today announced a strategic collaboration with GoPath Diagnostics , a leading full-service digital pathology and molecular diagnostics laboratory.
  • This partnership unites Nucleai and GoPath's complementary skills to expedite the development of new AI-powered clinical research and diagnostics.
  • The integrated solutions will be deployed within a centralized environment that meets the standards of the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Clinical Laboratory Evaluation Program (CLEP), Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP).
  • Jim Lu, M.D., CEO and Medical Director for GoPath Diagnostics, said: “Our collaboration with Nucleai transforms our capabilities, enabling GoPath to deliver a seamlessly integrated lab workflow.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in BioVie Inc. of Class Action Lawsuit and Upcoming Deadlines – BIVI

Retrieved on: 
Saturday, March 23, 2024
GCP, Macrocephaly, Prior, Shareholder, Form, Risk, District court, COVID-19, Patient, Purchasing, Ext, Acquisition, LLP, Good clinical practice, Scientific misconduct, Complaint, Insulin resistance, Clinical trial, Lung compliance, Pomerantz, Action Replay, Court, Person

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) and certain officers.

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against BioVie Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) and certain officers.
  • To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

ONGOING DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of BioVie

Retrieved on: 
Tuesday, March 19, 2024
GCP, Risk, COVID-19, Patient, Alzheimer's disease, Defendant, LLP, Good clinical practice, Clinical trial, OSI, Advertising, FDA, Court, Food, Pharmaceutical industry

Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia.

Key Points: 
  • Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia.
  • The firm has recovered hundreds of millions of dollars for investors since its founding in 1995.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding BioVie’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
  • The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com).

BIVI INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that BioVie Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!

Retrieved on: 
Tuesday, March 19, 2024
GCP, Macrocephaly, Risk, COVID-19, Good clinical practice, Complaint, Clinical trial, Court, Person

Such investors are encouraged to join this case by visiting the firm’s site: bgandg.com/BIVI .

Key Points: 
  • Such investors are encouraged to join this case by visiting the firm’s site: bgandg.com/BIVI .
  • or his Law Clerk and Client Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 332-239-2660.
  • If you suffered a loss in BioVie you have until March 19, 2024, to request that the Court appoint you as lead plaintiff.
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.

BIVI 4-DAY DEADLINE ALERT: Hagens Berman, National Trial Attorneys, Encourages BioVie (BIVI) Investors with Substantial Losses to Contact Firm Before Mar. 19th Deadline in Securities Class Action

Retrieved on: 
Monday, March 18, 2024
GCP, Macrocephaly, Risk, COVID-19, Patient, News, Person, Good clinical practice, Scientific misconduct, Science, OSI, Lung compliance, Hagens Berman, Pharmaceutical industry

]” This news drove the price of BioVie shares down $1.25, or almost 30% lower, on Nov. 9, 2023.

Key Points: 
  • ]” This news drove the price of BioVie shares down $1.25, or almost 30% lower, on Nov. 9, 2023.
  • On an event call, BioVie’s management suggested that the company became aware of Phase 3 deviations beginning as early as July 2023.
  • This news drove the price of BioVie shares crashing $3.03, or over 60% lower, on Nov. 29, 2023.
  • “We’re focused on investors’ losses and are investigating whether BioVie may have intentionally concealed GCP and protocol violations,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

DEADLINE ALERT for MBLY, FTFT, BIVI, and BTI: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Monday, March 18, 2024
GCP, Macrocephaly, Mobileye, Law, Fintech, Risk, COVID-19, Defendant, Security (finance), Good clinical practice, BTI, Suite, Complaint, Investment, Clinical trial, EyeQ, Future, American Tobacco Company, Lung compliance, Hand

LOS ANGELES, March 18, 2024 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • LOS ANGELES, March 18, 2024 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected] .
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • The Law Offices of Frank R. Cruz, Los Angeles