Perficient: Drug Development

JULY 3, 2023

Coveo’s platform is designed to meet stringent security standards, helping healthcare organizations comply with HIPAA regulations. Personalized Patient Experiences: Coveo’s AI-powered platform enables healthcare organizations to deliver highly personalized experiences to patients while adhering to HIPAA regulations.

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NIH Director's Blog: Drug Development

APRIL 2, 2020

The structural map of this interaction will help guide drug developers, atom by atom, in devising safe and effective ways to treat COVID-19. The protein is known to play a prominent role in the body’s complex system of regulating blood pressure. These ACE inhibitors lower blood pressure by causing blood vessels to relax.

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Perficient: Drug Development

NOVEMBER 27, 2023

This blog was co-authored by Carl Aridas and Joel Thimsen. In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. Build a reliable risk management strategy using accurate estimations and predictions.

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Perficient: Drug Development

MAY 30, 2024

LinkedIn | Blogs How We’re Approaching AI AI can be exciting—but it can also be intimidating, if your organization isn’t sure where to start. Perficient has years of AI experience and many successful AI-focused engagements under its belt, which means a mature, developed sense of how companies can implement it most effectively.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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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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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Ultimately, a smooth trial process paves the way for the development of promising therapies that will continue to help more patients.

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Perficient: Drug Development

FEBRUARY 26, 2025

This series of blog posts will cover main areas of activity for your marketing, product and UX teams in advance of, during and after site migration to a new digital experience platform. From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations.

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The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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DS in Pharmatics

FEBRUARY 24, 2023

Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market.

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Pharmaceutical Development Group

JANUARY 5, 2022

Compliance with these new focus points hinge upon proactive utilization Drug Development Services , effective FDA Pre-Submission, and comprehensive Regulatory Consulting. Collectively leveraged, this will focus on the FDA’s vital points and lead to FDA Drug Approval. Author Information William E. Spanogle, Ph.D.

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Perficient: Drug Development

NOVEMBER 10, 2023

This being the first blog post in a series of blogs by Perficient’s Financial Services Risk Management and Regulatory Capabilities Center of Excellence (CoE), we will be investigating the deposit structures of non-client banks over time.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. By Adrienne R.

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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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ACTO

DECEMBER 17, 2024

Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

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The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML.

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Perficient: Drug Development

SEPTEMBER 23, 2024

In this blog post, we delve into why focusing on user experience (UX) for healthcare auditory disabilities is crucial. Legal and Ethical Responsibilities Many countries have enacted laws and regulations that mandate accessibility for digital content. Promoting Inclusivity and Equality At its core, Universal Design is about inclusivity.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans.

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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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Perficient: Drug Development

DECEMBER 22, 2023

This blog was co-authored by: Ashley Simmons In conversations with financial services executives, Perficient consultants consistently delve into the application and usage of artificial intelligence (AI) within the industry. A pivotal aspect of this conversation revolves around the regulatory perspective toward AI.

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The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics.

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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. This blog was co-authored by Chandni Patel and Carl Aridas. Our banking risk and regulatory experts are excited to attend the upcoming XLoD Global event in New York on June 11th.

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Perficient: Drug Development

JANUARY 16, 2024

This blog, the first in a series by Perficient’s Risk and Regulatory Center of Excellence (CoE), provides actionable measures your company can adopt to safeguard against senior-level embezzlement risks and maintain the integrity of your institution’s financial transactions.

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Perficient: Drug Development

FEBRUARY 13, 2024

What to Expect Understanding HIPAA-Ready regulations and how Adobe addresses it: A review of HIPAA regulation and the relevance in healthcare commerce. Check out our blog series that discusses different use cases for HIPAA-Ready Adobe Commerce.

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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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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

However, with this most recent approval, FDA did not leave the question of durability as something to be answered postapproval, which signals to us that this issue looms large in FDA’s preapproval regulation of gene therapies. We can see this evolution for requiring longer-term follow-up play out with this most recent approval of Hemgenix.

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Perficient: Drug Development

OCTOBER 5, 2023

Sensory integration apps have emerged as powerful tools that foster cognitive development, independence, and enhanced quality of life for those facing cognitive challenges. For more information on why accessibility is important in general, you can check out my previous blog post here.

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Perficient: Drug Development

SEPTEMBER 20, 2023

In this blog post, we’ll explore why it’s essential to stay active while working from home and share some easy ways to keep those steps ticking throughout the day. Physical Health Benefits: Regular physical activity helps regulate body weight and supports a balanced metabolism, reducing the risk of obesity.

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Perficient: Drug Development

JUNE 13, 2024

As Salesforce developers, it’s crucial to ensure our code respects user permissions and profiles, enforcing the correct access controls. In this blog post, we’ll explore how to use the database methods available in Apex to check object and field accessibility, and we’ll include some practical coding examples.

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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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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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