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How the New EU AI Act Will Impact Clinical Trials in the Life Sciences?

Cloudbyz

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

Pharma Mirror

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion Market Demand appeared first on Pharma Mirror Magazine.

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SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Breaking Down Financial Barriers in Clinical Trials: Enhancing Equity and Access for Patients

Cloudbyz

Although participation in clinical trials is essential to medical progress, a little-known fact is that they are not sufficiently diverse. Ultimately addressing these financial barriers is crucial for the optimal participation of all individuals in clinical trials. percent Native American.

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The next phase of decentralisation in clinical trials

Pharmaceutical Technology

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time.

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EU clinical trials: ‘Application process is now simplified’

BioPharma Reporter

The new clinical trials regulation makes it easier to conduct clinical trials in the EU, according to an EU Commission representative.