Pharmaceutical Technology

SEPTEMBER 26, 2022

Two single-country trials and 44 multinational investigations with a site in Ukraine have started over the past six months, according to Global Data, with research covering infectious diseases, cardiology, schizophrenia, and gastrointestinal therapies. A clear path exists for clinical research to continue, with the potential to scale.

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Clinical Trials Clinical Trials Trials Regulation 130

Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. The post Accelerating Consumer Product Research with Unified Clinical Trial Management Solutions first appeared on CLOUDBYZ.

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Clinical Trials Clinical Trials Production Trials 52

pharmaphorum

APRIL 11, 2022

How can this data be incorporated into clinical trials?”. There was a huge opportunity for regulators to leverage real-world evidence and patient-reported outcomes data, captured through wearables, in addition to traditional clinical data. But the field was still pretty nascent at that point. This brings us to VivoSense.

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Clinical Trials Clinical Trials Trials Development 111

Cloudbyz

AUGUST 15, 2024

Answer: Trial Supply Management (TSM) refers to the processes and systems involved in managing the supply chain of investigational products during a clinical trial. Controlled Destruction: Coordinating the destruction of unused products in accordance with GMP and local regulations, ensuring that destruction is performed safely and securely.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

Clinical Trials 40

Clinical Trials Clinical Trials Trials Compliance 40

Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. Well-planned ADME investigations are conducted in the early stages of clinical research to generate this important data, which is needed for regulatory submissions.

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Bioavailability Manufacturing Drugs Production 130

Pharmaceutical Technology

NOVEMBER 1, 2022

The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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Big Data Regulation Medicine Research 278

pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders?

Life Science 98

Life Science Medicine Regulation Compliance 98

pharmaphorum

FEBRUARY 2, 2022

When teams opted for the former option, they found themselves having to learn how to deliver decentralised clinical trials ‘on the job’. If decentralised trials are to become the new normal in clinical research, it is essential to make sure we are doing it right, Dr Harris and Dr Carroll explained. But how do we package that up?”

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Trials Clinical Trials Clinical Trials Research 52

Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

MAY 27, 2022

wearable device carried by patients to measure certain health-related parameters, remote patient monitoring) and tele-healthcare in clinical trials (e.g. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. video consultations), health data analytics (e.g. What comes next?

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Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

MAY 26, 2022

The challenge for regulators and pharma companies is that safety and efficacy data from an RCT may not always translate to the real world ‘effectiveness’ of a medicine (how efficacious the drug is in patients once marketed) which is governed by these complex intrinsic and extrinsic factors. Why are certain ethnic groups underrepresented?

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Clinical Trials Clinical Trials Trials Medicine 143

XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

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Vaccine Vaccination Antibody Life Science 92