Perficient: Drug Development

APRIL 8, 2024

To bolster its capabilities and ensure compliance, the bank sought assistance from Perficient in delivering exceptional project and program management services to tackle their significant hurdles.

Compliance 52

Compliance Government International 52

FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

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Drug Development Molecular Biology Compliance Clinical Trials 52

Advarra

DECEMBER 14, 2023

Provide Visit Guidance and Calculators to Sites A Tufts Center for the Study of Drug Development (CSDD) study found the mean number of deviations and substantial protocol amendments has increased across all trial phases. The post How Sponsors and Sites Work Together to Improve Protocol Compliance appeared first on Advarra.

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Compliance FDA Clinical Trials Trials 52

Perficient: Drug Development

JANUARY 29, 2024

Integrating NLP Algorithms for Compliance To ensure compliance with the Illinois Artificial Intelligence Video Interview Act, employers can integrate NLP algorithms into their video interview processes: Consent Understanding: NLP algorithms can analyze and understand the language used in consent forms, ensuring they are clear and comprehensible.

Compliance 52

Compliance Government International 52

Perficient: Drug Development

AUGUST 17, 2023

The ripple effect will be essential as EV penetration continues to rise in the United States, although it also opens a whole new area of regulatory compliance with batteries which was not as big of a factor when EV penetration was much lower. Regulatory battery compliance cannot be an afterthought for OEMs manufacturing EVs and batteries.

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Compliance Regulations Production International 52

Perficient: Drug Development

SEPTEMBER 11, 2023

Already reviewed by Perficient, BES provides a secure and efficient portal to exchange documents, information, and communications for consumer compliance and Community Reinvestment Act (CRA) examinations. This month, the Federal Deposit Insurance Corporation (FDIC) launches it new Banker Engagement Site (BES) through FDIC connect.

Compliance 52

Compliance Regulations 52

Alta Sciences

AUGUST 18, 2023

Webinar— A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development iianiro Fri, 08/18/2023 - 19:49 URL [link] Description Save the date—Join us for a complimentary webinar for an overview of the draft FDA guidance on early-phase clinical development of psychedelics and how Altasciences can guide you through the process, (..)

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Drug Development Compliance Clinical Development FDA 40

DS in Pharmatics

OCTOBER 17, 2024

These specialists offer essential expertise in drug development, clinical trial design, regulatory compliance, and market strategy. Improve your pharmaceutical product’s chances of success by engaging a biopharmaceutical consultant.

Clinical Trials 52

Clinical Trials Compliance Drug Development Pharmaceuticals 52

Perficient: Drug Development

DECEMBER 18, 2023

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Compliance with these legal obligations is not only mandated by regulatory authorities but also necessary for maintaining an institution’s reputation.

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Regulations Compliance 111

thought leadership

AUGUST 19, 2024

QA responsibilities are shared between the actual manufacturing sites and the sponsors, who play a pivotal role in overseeing the quality management systems, setting quality expectations, and ensuring compliance throughout the drug development process.

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Compliance Clinical Trials Drugs Drug Development 52

DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

Production 52

Production Pharmaceuticals Compliance Drug Development 52

Perficient: Drug Development

AUGUST 4, 2024

Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount. Regulatory Reporting and Compliance Automation Compliance reporting is often a resource-intensive process.

Compliance 110

Compliance Marketing Production 110

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98

Perficient: Drug Development

AUGUST 12, 2024

Enhanced Security and Compliance Security and compliance are top priorities for any integration platform. Azure Integration Services benefits from Azure’s robust security features and compliance certifications.

Compliance 105

Compliance Licensing Licensing Production 105

Perficient: Drug Development

JULY 27, 2023

The Community Reinvestment Act (CRA) is a federal law in the US that promotes the interest of financial service firms to serve their communities’ credit needs, including low- and moderate-income neighborhoods.

Compliance 52

Compliance International Government Marketing 52

Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. Regulatory Compliance and Submission Typical process: Submissions to regulatory bodies usually require manual compilation of documents and individual submissions to each agency. However, it is often unengaging, cumbersome, and manual.

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Clinical Trials Trials Compliance Clinical Research 52

Perficient: Drug Development

OCTOBER 30, 2024

As part of the regulatory process, FinCEN may consider how financial institutions are currently using innovative approaches to compliance such as machine learning and AI, and the potential benefits and risks of specifying standards for those technologies.

Regulations 52

Regulations Compliance Government International 52

FDA Law Blog: Drug Discovery

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

H1 Blog

JULY 30, 2024

This sets the stage for binding and enforceable components per Section 3601 of the Food and Drug Omnibus Reform Act (FDORA), which will come into effect 180 days after the final guidance is published. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

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FDA Clinical Trials Compliance Pharma Companies 59

Alta Sciences

AUGUST 7, 2024

blussier Wed, 08/07/2024 - 19:51 HTML Timing is Everything Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing. Contact us today to discuss the next stage of your drug development journey.

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Clinical Trials Compliance Drug Development Trials 40

The Pharma Data

NOVEMBER 24, 2020

Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

FDA 52

FDA Drug Development Compliance Drugs 52

Perficient: Drug Development

NOVEMBER 6, 2024

SEC Chairman Gensler foresees potential systemic risks because the use of AI in the financial sector eventually may be driven by a small handful of foundational models, thus creating a “monoculture” with many market participants relying on the same dataset or model.

Regulations 52

Regulations Compliance Government Marketing 52

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

Science 59

Science Drugs Compliance Drug Development 59

Perficient: Drug Development

FEBRUARY 15, 2024

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

Compliance 52

Compliance Licensing Licensing Regulations 52

Conversations in Drug Development Trends

JUNE 13, 2024

The study focused on several key factors: DNA Yield and Quality Sample Stability Assay Outcomes Patient Compliance DNA Yield and Quality The study found that blood samples typically yield a higher quantity of DNA compared to buccal swabs. Buccal swabs had a compliance rate of 95%, compared to 69% for blood samples.

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DNA Compliance Clinical Trials Trials 72

Perficient: Drug Development

FEBRUARY 15, 2024

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

Compliance 52

Compliance Regulations Licensing Licensing 52

Alta Sciences

JULY 18, 2024

Preclinical manufacturing involves various sub-processes, all of which are critical in overall drug development. In each issue, they share their decades of knowledge to help sponsors along their early-phase drug development journeys, as well as explore the latest challenges and innovations in the industry.

Production 52

Production Clinical Trials Compliance Drugs 52

Perficient: Drug Development

MARCH 12, 2024

Whether it’s streaming processes, improving citizen services, or ensuring compliance, our specialized knowledge positions us as a go-to partner for government projects. Looking Ahead We are excited about the new opportunities the Government Specialization brings and are committed to continuing our journey of innovation and excellence.

Government 105

Government Compliance 105

Alta Sciences

JULY 10, 2024

Surveys have shown that patients prefer dermal routes of administration, and so dermal and transdermal drug delivery systems (TDDS), also known as patches, can provide greater patient compliance, ease of administration, and convenience—especially for conditions in which chronic use is necessary.

Clinical Trials 52

Clinical Trials Compliance Trials Drug Development 52

Perficient: Drug Development

OCTOBER 22, 2024

Greater Focus on Data and Compliance Risks With AI agents handling sensitive business functions like customer management and HR, companies like Klarna must ensure that data governance, compliance, and security are up to the task.

Compliance 52

Compliance Government International Regulations 52

Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Perficient: Drug Development

OCTOBER 15, 2024

In the banking sector, data governance is more than just a compliance checkbox. Financial services companies like AXA and ABN AMRO rely on these tools to handle everything from compliance workflows to data lineage mapping. .” If that doesn’t send a chill down your spine, nothing will. Why is Data Governance Such a Big Deal?

Government 52

Government Compliance Regulations Production 52

Perficient: Drug Development

DECEMBER 27, 2023

YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve. Contact us today to discuss in depth how we can help tackle your business challenges.

Compliance 52

Compliance Regulations Production 52

Precision for Medicine

DECEMBER 15, 2023

At Precision, our mission is to transform the drug development process and maximize benefits to patients and society. Extending beyond compliance, ESG is a reflection of our values and mission to create positive change for all stakeholders.

Government 52

Government Compliance Drug Development Drugs 52

Perficient: Drug Development

JANUARY 16, 2024

Regularly review and update policies annually to ensure compliance with current rules and regulations. Software tools to detect unusual patterns or transactions, risk management protocols, compliance assurance, regular reporting, and quality control.

Compliance 52

Compliance Regulations International Production 52

Perficient: Drug Development

JULY 3, 2023

Recently, Coveo hosted a webinar discussing the importance of HIPAA compliance in the digital world. Staying HIPAA Compliant with Coveo Compliance with HIPAA is essential for all healthcare organizations, as failure to do so can lead to severe consequences, including financial penalties and reputational damage.

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Compliance Regulations Doctors Hospitals 52

Alta Sciences

OCTOBER 28, 2024

Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. This resource provides valuable insights into optimizing drug development while ensuring regulatory compliance and innovative solutions for immunotherapy. Read or listen now. Watch the video.

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