Perficient: Drug Development

MARCH 25, 2025

Establish a single source of truth Create a glossary that doesn’t read like a legal document Accept that these definitions will change more often than a teenager’s social media profile It’s not perfect, but it’s governance, not a philosophical treatise on the nature of reality. So very, very wrong.

Government 52

Government Compliance Regulations 52

Drug Patent Watch

JUNE 23, 2025

By systematically monitoring and analyzing these documents… Patent filings represent one of the most valuable yet underutilized sources of competitive intelligence in the pharmaceutical industry.

Pharmaceuticals 58

Pharmaceuticals Drugs 58

Perficient: Drug Development

DECEMBER 19, 2024

Accessible Information and Communication Braille and Large Print: Provide medical documents, consent forms, and educational materials in Braille and large print. Personal Assistance: Provide trained staff or volunteers to assist patients with tasks such as filling out forms, finding their way, and accessing information.

Hospitals 52

Hospitals 52

Drug Patent Watch

JANUARY 15, 2025

Understanding Google Patents Google Patents is a search engine that allows users to search the full text of patent documents from around the world. This article explores the limitations of Google Patents in this context and suggests alternative approaches.

Drugs 52

Drugs Pharmaceuticals Engineering Research 52

The Open Targets Blog

JUNE 18, 2025

Find out more about target interactors in our documentation. The Platform does not have direct genetic evidence to link IFNAR1 to SLE, but there is an approved therapy, Anifrolumab, targeting IFNAR1 for SLE. Browsing interactors data shows that IFNAR1 interacts with TYK2, which has a well-known genetic association to SLE.

Pharmacogenetics 78

Pharmacogenetics Disease Drugs Therapies 78

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric. patent for the use of turmeric in wound healing.

Drugs 89

Drugs Drug Development Pharmaceuticals Production 89

Broad Institute

JULY 8, 2025

These features were chosen for their relevance as early indicators of dementia risk and are often documented only in narrative text. These features were incorporated into a predictive modeling framework aimed at identifying individuals at risk of developing dementia, with the broader aim of enabling earlier detection and intervention.

Bioinformatics 52

Bioinformatics Disease Drugs 52

Perficient: Drug Development

NOVEMBER 20, 2024

To implement this, you first upload your content (such as large documents or files) using the Files API. This documentation provides a knowledge base for future refinements and prevents regressions. Version Control and Experimentation Maintain a version-controlled repository for prompts. Associated performance metrics.

Engineering 52

Engineering International Production 52

The Pharma Data

JUNE 12, 2025

The most commonly documented Grade 3 or higher TEAEs were thrombocytopenia (59%), neutropenia (59%), and anemia (49%). The most frequently reported all-grade treatment-emergent adverse events (TEAEs) included nausea (65%), thrombocytopenia (61%), neutropenia (59%), and anemia (49%).

Treatment 40

Treatment Small Molecule Therapies Trials 40

Perficient: Drug Development

MARCH 4, 2025

Document and review FLS enforcement to avoid security loopholes. Best Practices for Handling FLS in Apex To ensure your Apex code respects FLS, follow these best practices: Always use Security.stripInaccessible() when working with records. Use WITH SECURITY_ENFORCED in SOQL to automatically enforce field security.

52

52

The Pharma Data

JUNE 18, 2025

Emprove® Program – Designed to support regulatory compliance and quality assurance, the Emprove® framework provides detailed documentation for raw materials, process chemicals, and single-use products, making regulatory filings more efficient and transparent.

Therapies 40

Therapies Science Disease Treatment 40

Quanticate

JULY 16, 2025

This Step 4 document is the version recommended for regulatory adoption across all ICH member regions. This article is based on the final, Step 4 version of the ICH E6(R3) Good Clinical Practice guidance, officially adopted on 6 January 2025 by the International Council for Harmonisation.

Clinical Trials 52

Clinical Trials Trials International 52

The Premier Consulting Blog

NOVEMBER 6, 2024

Developers must ensure that their CMC documentation is comprehensive, covering both the APIs and the device. By offering better symptom control, reducing exacerbations, and simplifying treatment regimens, these products help patients lead more active, comfortable, and fulfilling lives. What regulatory division governs ICPs?

Production 52

Production FDA Compliance Disease 52

Advarra

MAY 21, 2025

Our advice is to begin with a thorough review of your documentation, then once the gaps are identified, updates can be planned and implemented. Once documentation and systems have been reviewed and updated, the next step is to prepare your people and sites by conducing mock inspections, so they are always ready for inspection.

Pharma Companies 52

Pharma Companies FDA Trials Government 52

Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

The Pharma Data

JUNE 15, 2025

Infections were documented in 18 patients (58% of the study population), with 5 cases (16%) classified as serious; none resulted in a grade 5 event (death related to the study treatment). Evidence of Benefit in Difficult-to-Treat Subgroups Dr.

Therapies 40

Therapies Treatment Trials Clinical Trials 40

DrugBank

JUNE 18, 2025

Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations. A well-documented case is Sarepta Therapeutics’ eteplirsen , a drug developed for Duchenne muscular dystrophy.

Drug Development 52

Drug Development Clinical Trials Compliance Drugs 52

Advarra

JULY 3, 2025

Patient consent: Do your consent documents meet patients’ language and literacy needs across media formats (text, visuals, video)? Documentation: Do you have robust document storage and distribution processes outlined? Patient selection and public involvement: Have you reviewed your rationale for participant inclusion/exclusion?

Compliance 52

Compliance Trials Clinical Trials Laboratories 52

LifeSciVC

MAY 21, 2025

The structured written format (plus posting the document for all to see) focuses on the project rather than individuals, enables the whole group to view and contribute feedback, and discusses it in a setting where we can drive accountability.

Production 55

Production Drugs 55

Perficient: Drug Development

MAY 5, 2025

ContentArea = 5 ; }); Note that increasing this will increase the document size and make the synchronization job much slower depending on the amount of content and level of nesting in your site. If you are querying draft content you need to configure and enable preview tokens Documentation 4. AddContentGraph ( options => { options.

52

52

PPD

FEBRUARY 10, 2025

In contrast to traditional source data verification and source document review methods focusing on past events, RBM draws upon forward-looking capabilities, such as real-time monitoring and predictive modeling. It encompasses systems and processes used to identify, assess, control, communicate and review risks throughout clinical trials.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Perficient: Drug Development

MARCH 12, 2025

You can read the official documentation here. You can read the official documentation here. This SDK is historically based on Sitecore Discover whose cookies are similarly documented here ,e.g., These include Sitecore CDP, Sitecore Personalize, etc. For the remainder of this post, assume that version 2.5.5

Compliance 52

Compliance Production Marketing 52

The Premier Consulting Blog

DECEMBER 10, 2024

Validation involves detailed documentation of every step of the production process, from raw material sourcing to final product packaging in good manufacturing practice (GMP) compliant facilities. Detailed documentation and reporting of batch testing results are essential components of NDA submission. Complying with global regulations.

Marketing 52

Marketing Production Compliance Regulations 52

Drug Target Review

JULY 7, 2025

To overcome these hurdles, stakeholders must invest in collaborative research, transparent data sharing and regulatory science.

Drug Research 52

Drug Research Research Animal Testing Drugs 52

PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. It automates repetitive tasks such as documentation, summarization and annotation — significantly improving efficiency.

Clinical Research 98

Clinical Research Research Compliance Government 98

Alta Sciences

NOVEMBER 15, 2024

Specify your short-term objectives, such as starting a new trial phase, submitting additional regulatory documents, or expanding into new regions, along with your long-term goals. Being transparent about your needs and expectations will foster trust and enable the CRO to accurately craft a tailored strategy. IND, CTA, NDA, BLA). “If

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

The Pharma Data

JUNE 16, 2025

Neurologic events (NE) of any grade were documented in 33% of patients, with Grade 3 NEs in 4% and no Grade 4 or 5 NEs. Cytokine Release Syndrome (CRS) of any grade was reported in 76% of patients, while Grade 3 CRS was observed in only 4%. Importantly, there were no cases of Grade 4 or 5 CRS.

Therapies 40

Therapies Clinical Trials Disease Trials 40

Codon

APRIL 17, 2025

Still, despite the genus first being documented in 1839, the broader scientific community had been unaware of its capacity for mimicry. Still, scientists have documented both volatile chemical communication and bacterial gene-swapping in plants before, so these ideas at least have some basis in observed phenomena. Nobody yet knows.

Research 60

Research DNA Engineering Government 60

Perficient: Drug Development

JULY 17, 2025

env DATABASE_URL=postgresql://postgres:password@localhost:5432/ragchatbot_db # Get your key from [link] OPENAI_API_KEY=your-openai-key-here Preparing the Embedding Pipeline Sample data file Create input/data.txt with sample documentation or FAQs. Download the full file here. AcmeCorp Subscription Guide ## How do I renew my plan?

52

52

Quanticate

JUNE 19, 2025

Clinical trials rely on comprehensive data collection to prove the investigational drug/device’s efficacy and safety, the Case Report Form (CRF), a structured document designed to record all trial-related data for each participant makes this possible.

Clinical Trials 52

Clinical Trials Trials Drugs 52

Alta Sciences

MARCH 4, 2025

Many of the groups achievements have included raising critical challenges in study design and data interpretation, and providing feedback and suggestions to draft FDA guidance documents. One example is the recent interest in psychedelics for the treatment of psychiatric disorders, including major depressive disorder.

Clinical Trials 52

Clinical Trials FDA Drug Development Trials 52

PPD

DECEMBER 16, 2024

Top-tier CROs provide a full range of regulatory support , from submission strategy to post-approval maintenance, helping sponsors navigate complex landscapes, including: Early success Provide strategy development, module and content development, SME review, application publishing and maintenance submission Support a variety of submissions Assist with (..)

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Perficient: Drug Development

FEBRUARY 13, 2025

Best for: Blog posts, marketing pages, documentation. Static Generation (SSG) Caches pages at build time and serves static HTML files via CDN. Uses getStaticProps() to prefetch data only once at build time. Incremental Static Regeneration (ISR) Rebuilds static pages in the background at set intervals (without a full redeploy).

Engineering 52

Engineering Production Marketing 52

Drug Target Review

JULY 10, 2025

One key initiative was the creation of internal documentation and operational expertise tailored to customised automation. We started to build documentation and the expertise within the organisation here in Europe,” Basile added. “But But we are very good at customisation and can provide cost-efficient solutions.”

Cell Biology 59

Cell Biology International Production Research 59

The ChEMBL-og

JULY 10, 2025

In the next few months, our focus will be to develop a new curation/submissions tool that enables ChEBI curators and external users to efficiently annotate and add data into ChEBI, ensure that documentation is updated, and finally turn off the old interface.

Small Molecule 45

Small Molecule Bioinformatics Engineering 45

PPD

JULY 18, 2025

Prepare questions that are aligned with existing guidance documents, regulations and agency precedents — to demonstrate an understanding of the applicable framework and scientific rigor. This enables drug developers to define their objectives clearly for every meeting and curate and structure briefing materials with precision.

Regulations 52

Regulations Drug Development Clinical Trials Research 52

sptlabtech

DECEMBER 6, 2024

The benefits of 3D cell culture are well documented: Improved physiological accuracy : 3D models provide a more realistic representation of cell-cell and cell-matrix interactions, improving studies on cell morphology, differentiation, and drug responses.

Small Molecule 52

Small Molecule Research Drugs Science 52