Perficient: Drug Development

MARCH 5, 2024

Every developer should be instructed to reference and update this document as implementation evolves. Work with your IT and cybersecurity team to thoroughly screen the original author to avoid any potential risks.

International 111

International Government 111

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.

Drugs 87

Drugs Drug Development Production Pharmaceuticals 87

ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development.

Therapies 100

Therapies Licensing Licensing FDA Approval 100

KIF1A

JANUARY 13, 2024

Aditi Falnikar’s presentation from our 2023 KAND Conference Read the Article Rare Roundup FDA issues final guidance on rare disease drug development As we continue to explore new therapeutic avenues for treating KAND, it is crucial to think about the regulatory steps those therapies will face.

DNA 105

DNA Regulations Drug Development Disease 105

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.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

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

APRIL 1, 2024

In the Optimizely Search & Navigation admin view, administrators can set a certain weight of different properties (title, content, summary, or document content). According to the documentation, “The default property weight, 1, does not affect the score. And the boost weight of that matching condition is 2.

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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.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Perficient: Drug Development

OCTOBER 26, 2023

Since I referred to various online sources to execute this, I’ve documented the process below. While the documentation suggests creating or overwriting an icon pack to implement a custom icon (refer to: [link] ), I discovered that the method outlined below also works if you simply want to add a single icon other than an SVG.

Packaging 98

Packaging 98

Perficient: Drug Development

JULY 2, 2024

For more information, please refer to the Microsoft Graph connector documentation and the ServiceNow connector documentation. If you have any questions or feedback, please let us know in the comments section below. Disclaimer: Parts of this blog post were generated with the help of artificial intelligence.

Production 118

Production 118

Perficient: Drug Development

DECEMBER 18, 2024

Use Accessible Documents Large Print Materials: Provide printed materials in large print for patients with low vision. Braille Documents: Offer key documents in Braille for patients who are blind. Digital Text: Ensure that digital documents are accessible to screen readers.

Treatment 52

Treatment 52

Alta Sciences

OCTOBER 9, 2024

This document examines various analytical techniques that support pharmaceutical product development, with a focus on bioavailability. We take pride in developing, qualifying, and validating robust and rugged analytical procedures to ensure the quality of your products and meet the requirements of regulatory agencies worldwide.

Clinical Trials 52

Clinical Trials Drug Development Pharmaceuticals Trials 52

Perficient: Drug Development

AUGUST 14, 2023

Document all actions taken in Google Optimize. Documentation Checklist should include: A/B testing results Personalization campaigns Goals and Metrics setup Google Analytics audience setup Development workflows and troubleshooting documentation 2. As your business scales, so should your experimentation maturity.

Packaging 98

Packaging Marketing Trials Production 98

Fierce BioTech

SEPTEMBER 13, 2024

The new Guideline replaced the corresponding drug interaction guidance documents from the US FDA, EMA, and PMDA, among others.

Drugs 52

Drugs FDA Drug Development 52

Perficient: Drug Development

NOVEMBER 10, 2023

For more options and details on resetting the RDE for your program, review Adobe’s documentation on Experience League on this page. Multiple Developer Scenarios As with any development team, there will be a need for developers to collaborate on their development activities in a shared environment.

Packaging 105

Packaging Licensing Licensing International 105

Perficient: Drug Development

MARCH 19, 2024

Always have a list of contacts to whom you can direct any questions about the case or process to, including developers, PMs, or any other involved party. Document any failures, concerns or access issues in a list or table format depending on each requirement.

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102

Perficient: Drug Development

SEPTEMBER 4, 2024

The SDLC Waterfall Model Requirements Analysis: Gather and document what the system should do. Insufficient Requirement Gathering Sometimes, demands are not appropriately explained in the documentation, stories, or any part of requirement gathering, but for some tasks, we just don’t have standards to track but understandings.

Production 105

Production 105

Perficient: Drug Development

OCTOBER 25, 2023

The bulk of our customers have already started implementing, are actively exploring, or in the midst of documenting their point of view and roadmap on AI. Without a documented, aligned point of view and methodology, executive buy-in and employee engagement may not last. Central to this paradigm shift is Artificial Intelligence (AI).

Compliance 110

Compliance Production 110

Drug Target Review

DECEMBER 6, 2024

Public datasets, linked papers or supplementary documents often provide essential context about the experimental setup. This document summarises the data analysis process, including the key findings, statistical analyses, and interpretations. The final step is the generation of a report.

RNA 52

RNA Drugs Research Science 52

Perficient: Drug Development

APRIL 15, 2024

Leveraging these developer tools can help identify issues related to object recognition and interaction. Collaboration and Documentation: Debugging complex automation solutions often requires collaboration with other team members, such as business analysts or subject matter experts.

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The Premier Consulting Blog

JUNE 3, 2024

When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it starts by keeping the end in mind. It is a core document that positions and differentiates a product. It articulates the unmet medical needs of patients, physicians, and payers.

Production 52

Production FDA Drug Development Marketing 52

FDA Law Blog: Drug Discovery

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108

FDA Production Drugs Laboratories 108

Perficient: Drug Development

JUNE 28, 2024

For more information, please refer to the Microsoft Graph connector documentation and the ServiceNow connector documentation. You can also create custom verticals and result types to customize the search experience for your catalog items. Disclaimer Parts of this blog post were generated with the help of artificial intelligence.

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PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

International 87

International Clinical Development Clinical Trials Clinical Research 87

Quanticate

SEPTEMBER 2, 2024

One document which plays an essential role in the safety, traceability and overall validity of a clinical trial is the Statistical Analysis Plan (SAP). As a result, clinical trials must be performed to the highest degree of scientific and ethical standards, for results to be recognised as credible and the trial deemed as successful.

Clinical Trials 52

Clinical Trials Trials Clinical Research Production 52

Perficient: Drug Development

NOVEMBER 6, 2023

The Internal ChatGPT proof of concept was developed on Azure’s OpenAI chat interface. It enables employees to retrieve information from various documents and databases within a company’s internal network. This eliminates the need for manual searches through multiple documents, saving valuable time for employees.

International 64

International Regulations Production 64

Perficient: Drug Development

JUNE 25, 2024

Apache PDFBox is a versatile open-source library designed to work with PDF documents. It is widely used in various Java applications to create, modify, extract, and print PDF documents. Key Features of PDFBox PDF Creation PDFBox allows developers to create new PDF documents programmatically.

52

52

Fierce BioTech

APRIL 4, 2024

Discover how leading organizations leverage AI to revolutionize operations and expedite drug development, ensuring faster access to life-saving treatments. Ensure regulatory compliance through efficient management of documentation, audits, and reporting, powered by AI automation.

Science 52

Science Compliance Drug Development Treatment 52

Drug Patent Watch

DECEMBER 10, 2024

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

Compliance 52

Compliance Pharmaceuticals Pharmaceutical Companies Regulations 52

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 Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.

FDA 64

FDA Drug Development Disease Trials 64

PPD

JUNE 10, 2024

This update reflects the integrated and expansive approach we bring to your drug development journey. As a part of Thermo Fisher, we bring you an expanded portfolio of offerings across all phases of drug development. It’s a visual representation of our enhanced capabilities and integrated solutions.

Clinical Research 52

Clinical Research Research Drug Development Therapies 52

Perficient: Drug Development

DECEMBER 11, 2023

Getting Technical Okta’s documentation provides implementation insight for the Remember Device feature. What is Okta’s widget doing that it’s documentation is hiding from us? This is where Remember Device comes in and allows users to conveniently access their accounts without the need for frequent MFA.

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105

Perficient: Drug Development

JUNE 25, 2024

To do this, utilize PDFBox, a Java library for managing PDF documents, in combination with Selenium, a potent web automation tool. It enables the creation, modification, and extraction of content from PDF files by developers. Key Features: PDF Creation: Enables the creation of new PDF documents from scratch.

Packaging 52

Packaging 52

Perficient: Drug Development

MAY 1, 2024

Note : Content Search API will require CORS policy to be able to work, to read more about the configurations, please refer to this document for details. Prerequisites Content Delivery API and Content Search API need to be installed and configured properly in your source application. You also have to reindex the site after installation.

Packaging 105

Packaging Production 105

Perficient: Drug Development

NOVEMBER 21, 2023

As I navigate this powerful framework, I’ve decided to document my experiences, insights, and newfound knowledge in a blog series. I am thrilled to embark on a journey of exploration and learning with you as I dive into the fascinating world of Spring Boot.

Production 116

Production 116

Perficient: Drug Development

FEBRUARY 14, 2024

Generative AI at Perficient From chatbots to intelligent document automation, Perficient is helping organizations utilize AI and generative AI to streamline business processes and improve the customer experience.

Marketing 115

Marketing International Research Production 115