Perficient: Drug Development

MAY 30, 2024

The world’s leading financial institutions and regulators come together at XLoD to discuss the future of non-financial risk and control. They want to know how AI and machine learning can enhance the capabilities of compliance, legal, and risk professionals in managing non-financial risk.

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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. What Can OEMs Do to Manage Changing Battery Regulations?

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Advarra

DECEMBER 14, 2023

b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time.

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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. By the time people started speaking of Y2K , regulators were accepting documents from the bank prior to starting the onsite examination.

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Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This comparison enables your teams to assess process effectiveness and identify deviations that require attention due to inefficiencies and/or non-compliance.

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Perficient: Drug Development

SEPTEMBER 6, 2023

The regulators feel that this proposed LTD rule would: Improve the resolvability of these banking organizations in case of failure, Potentially reduce costs to the Deposit Insurance Fund, and Mitigate financial stability and contagion risks by reducing the risk of loss to uninsured depositors.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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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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Perficient: Drug Development

JANUARY 16, 2024

Regularly review and update policies annually to ensure compliance with current rules and regulations. Implement a check and balance or send policies/procedures through a multi-business review approach to confirm documentation updates and adherence to current rules and regulations.

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Perficient: Drug Development

DECEMBER 27, 2023

Once published by regulators, Perficient’s Risk and Regulatory CoE will be here to walk our clients through the changes. 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.

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Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators. However, it is often unengaging, cumbersome, and manual.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. The team analyzing the data warehouses, the data lakes and aiding the analytics will have to have this one major organizational goal in mind.

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Perficient: Drug Development

DECEMBER 6, 2023

The objective is clear: encouraging compliance with consumer protection regulations they deem important before punitive measures are implemented broadly. Why Companies Need to Review Their Practices Legal Compliance: The rapidly evolving landscape of consumer protection laws demands constant vigilance.

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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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Perficient: Drug Development

JULY 12, 2023

Perficient provides risk management to more than 500 financial services organizations, many of whom have multiple bank regulators. Often an organization will have a state-charted non-member bank, which has the FDIC as its primary federal regulator.

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Perficient: Drug Development

JUNE 19, 2024

Our risk and regulatory compliance experts, Carl Aridas and Chandni Patel, have just returned from XLoD 2024 in New York. The event brought together the world’s top financial institutions and regulators to discuss the future of non-financial risk and control.

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PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

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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.

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Perficient: Drug Development

FEBRUARY 29, 2024

A well-structured, well-executed tagging strategy can enhance data classification, enable regulatory compliance and streamline data lifecycle management. Geo-coding data with tags to comply with European regulations is also a possible target of opportunity. Tagging can make these assets more seachable, manageable and governable.

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Perficient: Drug Development

JUNE 4, 2024

By leveraging self-hosted runners for deployment, organizations can optimize control, customization, performance, and cost-effectiveness while meeting compliance requirements and integrating seamlessly with existing infrastructure and tools. Here are few advantages of self-hosted runners as given below.

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Vial

FEBRUARY 15, 2024

Rising costs : The rising costs of clinical trials, including expenses associated with recruiting participants, trial infrastructure, data management, and regulatory compliance, is a critical issue4,5. Their expertise in protocol design and regulatory compliance accelerates trial initiation and execution, reducing regulatory setbacks.

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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.

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Perficient: Drug Development

AUGUST 4, 2024

Enhanced Security and Compliance Security and compliance are primary concerns for businesses today. Microsoft CSPs bring a wealth of knowledge in implementing robust security measures and ensuring compliance with industry standards and regulations.

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Perficient: Drug Development

SEPTEMBER 7, 2023

It requires precision, coordination, and control to ensure financial data accuracy and compliance. Whether it’s quarterly reports, annual statements, or compliance documents, you can produce them efficiently and accurately. Data Security and Compliance Maintaining data security and compliance is paramount in finance.

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Perficient: Drug Development

JUNE 13, 2024

Compliance: Many industries have strict data privacy regulations. Verifying accessibility helps maintain compliance with these regulations. Compliance: Maintain adherence to industry regulations. Benefits Recap: Data Security: Prevent unauthorized data access and protect sensitive information.

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Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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Perficient: Drug Development

JULY 14, 2024

Compliance and Ethical Responsibilities Legal Compliance: Universal Design aligns healthcare facilities with legal requirements for accessibility and non-discrimination under disability rights laws. This ensures compliance with regulations and promotes fair treatment of all patients.

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Perficient: Drug Development

DECEMBER 22, 2023

This mitigates the risk of customer service representatives providing incorrect information and ensures compliance with regulatory disclosures, ultimately enhancing the overall customer experience while reducing costs. Contact our experts today if you are interested in learning more about up-and-coming news in financial services.

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Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Author Information William E. Spanogle, Ph.D.

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Perficient: Drug Development

JANUARY 3, 2024

Additionally, these branches underwent annual on-site inspections to ensure compliance with regulations. This shift also led to technological advancements enabling firms to closely monitor broker activity to ensure full compliance at all times.

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Perficient: Drug Development

NOVEMBER 7, 2023

For healthcare entities, this change is intensified by stringent regulations, intricate procedures, and the vital importance of patient care and member services. Adhere to Regulations : Ensure Agile processes align with healthcare regulations like HIPAA. Compliance and data security are paramount.

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Perficient: Drug Development

APRIL 18, 2024

Open banking transforms the way financial data is shared and accessed, allowing third-party data providers and other banks to access financial data in traditional banking systems through application programming interfaces (APIs). Traditionally, banks hoarded financial data, sharing it sparingly on a need-to-know basis.

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