Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.

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Clinical Trials Clinical Trials Gene Trials 52

Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Cost: Manufacturing cell and gene therapies can be expensive, especially for small patient populations, which can impact the overall viability of a trial.

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Gene Therapy Gene Trials Clinical Trials 52

Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

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Clinical Trials Clinical Trials Compliance Trials 66

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra. Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

ACRP blog

JULY 26, 2023

But it’s not just about study design—educating patient advocacy groups about clinical research can also help to increase public awareness of the importance of clinical trials.” That session is available as part of a Regulatory & Compliance replay package of conference sessions or in the Full Program replay package.]

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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. Regulatory Compliance Compliance with regulatory requirements is critical for CROs.

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Compliance Branding Packaging Packaging 79

Cloudbyz

AUGUST 9, 2023

Let’s delve into why this method is paramount for the transformation of clinical research management. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Marketing 52

Marketing Compliance Packaging Packaging 52

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program. Media Contact: Andrew Baud, Distil,?

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Life Science Clinical Trials Clinical Trials Compliance 52

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Clinical Research Research Clinical Trials Clinical Trials 105

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

ACRP blog

JULY 26, 2023

But it’s not just about study design—educating patient advocacy groups about clinical research can also help to increase public awareness of the importance of clinical trials.” That session is available as part of a Regulatory & Compliance replay package of conference sessions or in the Full Program replay package.]

Clinical Research 52

Clinical Research Clinical Research Coordinator Packaging Packaging 52

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Marketing 40

Marketing Compliance Packaging Packaging 40

Cloudbyz

FEBRUARY 3, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). Opening up our doors for Clinical Research Organizations looking to streamline their existing as well as future research activities. How can virtual trial ease the process? Resource Management.

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Clinical Trials Clinical Trials Trials Packaging 83

pharmaphorum

AUGUST 5, 2020

Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Ophthalmic Drug Delivery is compelling for many reasons, including the major issue of patient compliance and tolerability of therapies. Benefits of attending: Identifying unmet clinical needs favouring DD technology. OphthalmicDrugs.

Drug Delivery 52

Drug Delivery Trials Development Drugs 52

Cloudbyz

DECEMBER 30, 2020

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). Remember, a clinical trial is an evolving process, and your CTMS should be adept at accommodating your future evolving needs and not let you replace the CTMS a few years down the line. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 52

The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Clinical Supply Gene Therapy Gene Development 52

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. The first is a lack of standardisation in trial design, which leads to delays in study setup. The future is automation.

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Clinical Trials Clinical Trials Trials Compliance 98

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

JUNE 1, 2021

This technology can also play an important role in supporting virtual clinical trials. Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. The threat of illegal online pharmacies.

Medicine 52

Medicine DNA Pharmacy Production 52

Drug Discovery World

JULY 11, 2022

These challenges exist across the translation cycle from early research to clinical trials, manufacturing, and ultimately reimbursement. The complexities of sample management can significantly extend the timelines for clinical trials. Methods& clinical development, 21,524–529. Regulatory requirements.

Gene Therapy 52

Gene Therapy Gene Development Production 52

Advarra

JUNE 6, 2022

A: If the GCLP term referenced is interpreted as a combination of good laboratory practice (GLP) and good clinical practice (GCP), then the roadmap needs to include processes covering pre-clinical and clinical development stages. However, this is not a requirement, and it may not deliver an enhanced level of compliance.

Compliance 52

Compliance Development Production Manufacturing 52

Cloudbyz

JANUARY 13, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry. eCOA / ePRO.

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Advarra

JUNE 28, 2022

Ensure your study has evidence to support the robustness of the assay used in evaluating the clinical trial. One of the biggest reasons sponsors receive a clinical hold is the IND lacks organization and clarity. It may take 12-14 months to complete the IND package, not including the time commitment for the pre-IND.

Regulation 52

Regulation Drugs Manufacturing Development 52

Cloudbyz

JANUARY 20, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). Although clinical trials have made significant progress over the years, there is still little or no ecosystem collaboration. Resource Management. Agile Portfolio Management. Study Start-up.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 25, 2022

Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. A dedicated team-based approach to project management from formulation and development through manufacturing, analytical, packaging, and regulatory review can also streamline PDF production.

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Manufacturing Production Pharma Companies Development 130

Drug Discovery World

MARCH 27, 2023

The UK government endorses TREs, having recently announced an investment package of up to £200 million in TREs and digitally enabled clinical trials 4. TREs are already paving the way to greater collaboration in drug development, improvements to existing treatment approaches, and driving better patient outcomes.

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Genome Genomics Research Scientist 52

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.

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Production Manufacturing Vaccination Vaccine 52

Pharmacy Checkers

DECEMBER 12, 2019

A majority of inspections resulted in findings of non-compliance. For each drug regulatory authority, before a drug is approved, three phases of clinical trials of increasing complexity and scope in human subjects and proof that a drug will be manufactured correctly under Current Good Manufacturing Practices are required.

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Drugs Manufacturing Medicine Compliance 71

The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021.

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Antibody Sales Production Development 52

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period.

Production 52

Production Branding Marketing Licensing 52

Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Staying informed of regulatory changes is crucial for businesses to ensure continued compliance and avoid disruptions in their operations.

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Pharmaceutical Technology

JANUARY 20, 2023

While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights. To learn more about how Tanner is adapting to changes in the clinical trial supply chain and embracing technological innovations, download this white paper.

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