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e-pharmacies informed CDSCO they are only providing online platform connecting users & pharmacies: Minister

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations. The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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Centre puts onus on SLAs to take action against e-pharmacies for violation of D&C Act and Rules

AuroBlog - Aurous Healthcare Clinical Trials blog

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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Pharmacy and clinical research: the pharmaphorum podcast

pharmaphorum

The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinical research. He explores how COVID-19 has disrupted healthcare delivery and why virtual and decentralised trials could help increase patient access.

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Decentralized Clinical Trial Models: Are They Here to Stay?

ACRP blog

Decentralized clinical trial (DCT) elements enabled clinical research to continue during the pandemic, when physical attendance at healthcare facilities was often impossible. Author: Jill Dawson The post Decentralized Clinical Trial Models: Are They Here to Stay? appeared first on ACRP.

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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Pharmacy File Ensure inventory records are up to date.

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Orvacabtagene autoleucel by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

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