Drug Target Review

JUNE 13, 2025

Beginning with a degree in biomedical engineering, her passion for research and the ethical treatment of animals led her down a different path. “I I was good at maths and science and interested in medicine, so I pursued biomedical engineering. Liz Nunamaker’s career path has been far from conventional.

Research

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

Clinical Research

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 These regulations demand that healthcare AI be specifically tailored to ensure data privacy, security, and compliance, limiting the utility of plug-and-play approaches seen in other industries.

Regulations

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 These regulations demand that healthcare AI be specifically tailored to ensure data privacy, security, and compliance, limiting the utility of plug-and-play approaches seen in other industries.

Regulations

Perficient: Drug Development

APRIL 28, 2025

The Illusion of Data-Driven Greatness Some time back , I was working on a project where a major trading platform launched a new engine to automate trade surveillance and compliance monitoring. Compliance officers were drowning in noise!!! Historical compliance notes were inconsistently formatted and misclassified.

Government

Perficient: Drug Development

OCTOBER 9, 2024

Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. This not only fulfills moral, ethical, and regulatory obligations but also opens up new market opportunities. billion people with $1.9

Compliance

ASPET

AUGUST 21, 2024

Those models along with the surrogate markers can play important roles in quantifying TdP risk of new compounds, impacting late-phase clinical design and regulatory decision-making, and preventing adverse events on post-marketing clinical use.

Compliance

Perficient: Drug Development

JUNE 25, 2024

ADA compliance ensures that your e-commerce site is usable by people with visual, auditory, and other impairments. Who needs to follow ADA compliance standards? Let’s have a deeper look at ADA compliance and what it means for eCommerce stores. Look for themes that explicitly mention ADA compliance. What is WCAG?

Compliance

Perficient: Drug Development

SEPTEMBER 6, 2024

Salesforce’s position as a leader in this report reflects its current offerings, robust strategy, and strong market influence. Strategy: Forrester evaluates the vendor’s long-term vision, innovation roadmap, and ability to address future market needs.

Marketing

Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

Regulations

Perficient: Drug Development

MARCH 22, 2024

Migration and modernization are vital to reach new markets, deliver innovative products, improve resiliency, reduce costs, and improve customer experiences. Data Insight : Data is the engine driving intelligent decision-making. Cloud modernization is the primary driver of digital transformation and impactful business value.

Government

Perficient: Drug Development

MARCH 12, 2024

Embracing Regulatory Compliance with HIPAA Sitecore’s commitment to regulatory compliance, especially concerning HIPAA, further strengthens its position in the healthcare sector. A well-optimized search engine can significantly enhance the patient’s journey by providing accurate, relevant, and timely information.

Marketing

Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. If approved, the company can then market and distribute the therapeutic. How do BioDAOs differ from investment DAOs?

Engineering

Drug Target Review

AUGUST 6, 2024

Cardiovascular diseases : Atherosclerosis : ADCs could be engineered to target and deliver drugs to atherosclerotic plaques, potentially stabilising them and preventing cardiovascular events. Finally, companies evaluate potential return on investment (ROI), considering development costs, time to market, pricing, and reimbursement prospects.

Therapies

FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

FDA

Drug Target Review

APRIL 5, 2024

Together, these attributes provide a strong foundation for protein expression with enough adaptability to produce much of the commercial and therapeutic protein market. The upfront investment in identifying a high-quality CDMO will pay dividends with a stable, high-quality cell line that companies can feel confident going to market with.

Protein Production

Perficient: Drug Development

JULY 24, 2025

Concept & Feasibility: Design for commercialization from day one Successful MedTech products start with a clear understanding of unmet clinical needs, market dynamics, consumer expectations, and regulatory pathways. Hospitals are increasingly unwilling to adopt devices that require complex IT overhauls.

Production

Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. The compliance deadline, however, depends on the firm’s total receipts from calendar years 2023 and 2024. Compliance deadlines follow a staggered rollout based on total assets. Ready to explore your firm’s compliance with Rule 1033?

Compliance

Drug Patent Watch

DECEMBER 10, 2024

Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines. Regulatory professionals play a crucial role in navigating the regulatory landscape, ensuring compliance with guidelines and regulations, and communicating with regulatory agencies.

Drug Development

Perficient: Drug Development

JANUARY 16, 2024

a healthcare and life sciences software engineering firm based in San Diego, California, with European operations located in Cluj-Napoca, Romania. We’re a full-service software engineering service provider focused on improving the patient experience through innovative software solutions and technologies.

Science

ACTO

SEPTEMBER 26, 2023

According to a study by Growth Engineering, personalized learning programs can boost engagement by up to 60% compared to traditional one-size-fits-all training approaches. Compliance Training Regulatory compliance is essential, so when introducing personalized learning, ensuring it maintains all compliance requirements is a must.

Compliance

Perficient: Drug Development

FEBRUARY 14, 2024

You’ve got compliance training, processes training, training from corporate leadership, onboarding training for new team members and more. But there’s one more type of training your healthcare content strategists and marketers need that you’re (probably) not doing: healthcare writing training. But that should just be the first step.

Engineering

Perficient: Drug Development

JUNE 21, 2024

Increasing Key Metric Conversions Accessibility is crucial in driving key metric conversions, offering substantial and measurable business benefits beyond compliance. Expanded Market Reach: By implementing accessibility practices, businesses can tap into an underserved market segment.

Compliance

Drug Target Review

AUGUST 9, 2024

It continues from drug candidate screening and selection, prototype generation, preclinical validation, early clinical studies, to later clinical studies and post-market monitoring. 3 Patient compliance is a critical but complex challenge, with contributing factors reaching beyond just drug formulation. What is the API’s solubility?

Science

Alta Sciences

MARCH 8, 2024

So much so that the HPAPI market is estimated to reach USD 31.5 Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects. billion by 2029.

Compliance

Perficient: Drug Development

NOVEMBER 28, 2023

We imagine, create, engineer, and run digital transformation solutions that help our clients exceed customers’ expectations, outpace competition, and grow their business. Traded on the Nasdaq Global Select Market, Perficient is a member of the Russell 2000 index and the S&P SmallCap 600 index.

Compliance

Perficient: Drug Development

SEPTEMBER 11, 2024

Thousands of brands, marketers, technologists, and digital visionaries come together for three days of top-notch networking, inspiring success stories, innovation-driven sessions, and more. Sitecore Symposium is Sitecore’s biggest event of the year.

Compliance

Perficient: Drug Development

JANUARY 3, 2024

Here are the top 7 reasons this should be the case: XM Cloud Empowers Marketers to Create their own Components and Get Started with Personalization XM Cloud provides a brand-new WYSIWYG component building experience to marketers, who can lay out their components however they want and use them directly in pages.

Compliance

Drug Target Review

DECEMBER 5, 2024

2,3 Engineering both the capsid and DNA cargo improves the safety and efficacy of rAAV vectors and expands their clinical applications. As a result, there is a need for validated AAV testing solutions to meet quality standards as well as compliance and regulatory requirements. Bio-Rad, Bulletin 3725 [cited 2024 Oct 28].

Therapies

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.

Laboratories

Perficient: Drug Development

MAY 16, 2024

Observing GAAD raises awareness about these legal obligations and encourages compliance to ensure equal access and prevent discrimination. Accessible design expands market reach, enhances customer satisfaction, and fosters brand loyalty. GAAD is a reminder that together, we can create a more inclusive and accessible world for all.

Production

The Pharma Data

NOVEMBER 15, 2020

Pre-clinical studies of MINIject highlighting the anti-fibrotic properties of its STAR ® material were recently published in BMC Biomedical Engineering. 3 Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.

Trials

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

Production

The Pharma Data

MAY 3, 2021

Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research. Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets. Continuous professional development. RAPS 2021 Convergence (December).

Production

Perficient: Drug Development

JUNE 25, 2024

Learning from history, he referenced the lack of regulatory controls in derivatives and financial engineering before the 2008 financial crisis, and more recently, the unregulated growth of cryptocurrencies leading to the “Crypto Winter” of 2022. The evolution of electronic trading provides a valuable case study to consider.

Regulations

Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 Our proactive team of innovators, engineers, and ClinOps (Clinical Operations) leaders have built a global, full-service CRO powered by intuitive end-to-end technology.

Clinical Trials