Court Square Group, Inc. -

SUMMARY

In order to meet their first FDA submission deadline a spin-off division of a large life science company needed to implement Electronic Document Management Systems (EDMS), electronic Common Technical Document (eCTD)solutions to manage their documents, clinical trial information, and FDA submissions. The division had a corporate directive to file their initial NDA (New Drug Application) with the FDA in less than a year. Due to already overstretched resources, the corporate IT department would not be able to initiate an evaluation or begin the implementation of EDMS and eCTD solutions for at least one year.

Court Square Group (CSG) implemented and hosted multiple applications within CSG’s Audit Ready Compliant Cloud™(ARCC) environment and provided a fully functioning submission environment in less than three months. Court Square Group’s solution enabled the client to implement, train and submit the necessary documentation to the FDA for their first approval even earlier than the anticipated deadline.

THE CLIENT

The client is a new pharmaceutical start-up division of a large medical device manufacturer that was tasked with producing the first pharmaceutical products for the company. The client had a drug candidate that they intended to bring to market within the year.

Court Square Group, Inc. -

SUMMARY

A growing CRO recognized that the amount of time spent to ingest documents from multiple clinical sites over multiple trials significantly increased costs and project delays. As the number of trials expanded, the increase in costs and delays became even more troubling. The problem was compounded by a dwindling number of CRAs who possessed knowledge to classify these documents due to workforce challenges. The CRO set out to find a solution to more effectively utilize the people within the company.

ABOUT THE CLIENT

A growing CRO recognized that the amount of time spent to ingest documents from multiple clinical sites over multiple trials significantly increased costs and project delays. As the number of trials expanded, the increase in costs and delays became even more troubling. The problem was compounded by a dwindling number of CRAs who possessed knowledge to classify these documents due to workforce challenges. The CRO set out to find a solution to more effectively utilize the people within the company.

THE CHALLENGES

The first challenge was to ensure that the personnel reviewing the documents from the clinical sites were able to process those documents. Often, multiple documents were combined, scanned, saved in a single PDF and emailed to the CRAs. Extracting, separating, and determining what to do with each document was a very manual effort. CRAs needed to manually break up large files into several individual documents. After the documents were separated, CRAs needed to apply a standard naming convention.

Often clinical sites provided files with non-conforming file names. Once renamed, each document was filed into the appropriate location in the DIA eTMF file/folder structure. This labor-intensive process required knowledge of the overall eTMF structure and for the CRAs to read each document and determine the appropriate folder to store the document based on the content within.

THE SOLUTION

Qinecsa Solutions -

Join us for Part 2 of our webinar series on post-marketing safety surveillance, where we dive deeper into the intricate world of medical devices and drug-device combination products.

Building upon the foundation set in Part 1, this session explores the reporting essentials and obligations associated with the post-marketing safety surveillance of these products in both the EU and USA markets. Industry expert Veronika Valdova will guide you through current trends and challenges in the industry, offering valuable insights into best practices and regulatory expectations. Attendees will gain a comprehensive understanding of how to navigate the complexities of safety surveillance and ensure compliance with international standards.

Agenda:

• Introduction Drug-Device and Combination Products.
• Types of DDCs in Europe and the U.S.
• Reporting Essentials and Obligations
• Essential Procedures to Cover
• Comparison of Reporting Requirements in the EU vs the U.S.
• Current Trends and/or Challenges
• Best Practices
• Key Takeaways
• Q & A Session

For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy! 

Qinecsa Solutions -

Join our insightful webinar exploring the latest developments in the EU medical device vigilance landscape, with industry-renowned specialist Veronika Valdova. Learn how to seamlessly integrate medical devices into your pharma portfolio, gain practical strategies for navigating regulations, and establish robust management processes.

Key topics include: 
• Introduction to Medical Device Regulatory Requirements
• Addressing Practical Challenges
• Key Takeaways
• Q&A Session

🎯 This webinar is ideal for: 
• MedTech company leaders in acquisition by pharma
• Pharma company leaders expanding their portfolio to include device products.

For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy! 

Insife -

Read how Insife has created a unique service that can help pharma companies and biotechs, big and small, as well as CROs, by taking on the work of tracking changes in global regulation

Content Rules, Inc. -

In this white paper, we show how content reuse and automation streamlines the end-to-end content journey. We include examples of content reuse opportunities inherent to regulatory content and provide an overview of how to create a reuse strategy that works for you. You'll learn:

• What is the pharma content evolution
• What is a content reuse strategy
• The risks and costs of ‘content drift’
• How content reuse and automation directly impact the business
• How to create a content reuse strategy

Insife -

Read how Insife's automated Case Intake solution uses AI

Schlafender Hase -

Intensifying regulatory requirements leave no room for error when putting goods into patients and consumers’ hands. Yet in life sciences, one of the most strictly controlled industries, more than 50% of product recalls are caused by packaging errors. 

Is your company taking all the necessary steps to ensure labeling compliance and accuracy? 

Schlafender Hase -

Accurate barcodes on healthcare packaging and labeling are just as important as any other information. An incorrect barcode can lead to expensive misprints and recalls.

When it comes to grading a digital barcode, there should never be a result other than Pass or Fail – either it is perfect or it is not.

Is your company taking all the necessary steps to ensure that your barcodes scan correctly?

Schlafender Hase -

Regulators in the life sciences industry are making clear moves to connect patients, physicians and other stakeholders across the healthcare system by implementing e-labelling initiatives. 

The goal of these initiatives is to ensure a sustainable and consistently up-to-date information source for product and safety information that isn’t dependent on paper. 

This eBook assesses the latest regulatory expectations and timelines applicable to the medical device industry. It then sets out the practical next steps manufacturers and suppliers can take now – both to prepare for compliance and to maximize the opportunities operationally and for customers.

OM1 -

In this ebook you will discover research and patient journey insights using OM1 artificial intelligence models, how PhenOM works, and why OM1 is different.

OM1 -

In this E-Book you will find information about our automated evidence generation for streamlined clinical research.

OM1 -

In this E-book, you will find insights on our three analytic reports: Reasons for Discontinuation Comparative Outcomes Perscriber Trends

OM1 -

In this E-Book you will find a sampling of insights and case studies that address challenges in medical device research with solutions using RWD and artificial intelligence (AI).

LARVOL -

AI and ChatGPT are valuable tools in the field of medicine. There are numerous benefits of using them in drug discovery, clinical trials, patient treatment. However, the integration of AI and ChatGPT in healthcare presents several challenges that need to be addressed. Join us, as we explore the opportunities and challenges associated with the use of AI and ChatGPT in medicine. 

LARVOL -

In the fast-paced and complex world of the pharmaceutical industry, being ahead of the curve is not just a competitive advantage - it's a necessity. This is where the art of competitive intelligence (CI) comes into play, a strategic chess match where pharma teams use knowledge and insights to outmaneuver their competitors.

Glemser Technologies -

In today’s rapidly evolving landscape of content management, organizations are increasingly seeking innovative approaches to streamline workflows, enhance collaboration, and meet stringent regulatory compliance. Among these transformative solutions at their disposal, the component content management system (CCMS) shines as a beacon of innovation, pushing the boundaries of traditional content management systems (CMS) by delivering a new level of efficiency, structure, and scalability.

In this blog, we delve into the realm of CCMS, exploring its unique features, its divergence from conventional content management systems, and the promising benefits it brings, particularly for regulated industries like pharmaceuticals.

Glemser Technologies -

In the fast-paced and highly regulated pharmaceutical industry, the efficient management of labeling and regulatory submissions is crucial for ensuring compliance, patient safety, and the fast and successful market entry of innovative drugs. However, this process comes with its fair share of challenges. From navigating Chemistry, Manufacturing, and Controls (CMC) regulatory requirements to addressing global labeling and clinical labeling use cases, pharmaceutical companies face complex hurdles in meeting regulatory standards while improving their speed to market. This leaves many highly regulated life science organizations to wonder – is it possible to increase speed while increasing compliance?

G&L Healthcare Advisors -

At G&L Healthcare Advisors, we utilize decades of experience in Regulatory Affairs, Quality Assurance and Clinical Development to design and deliver solutions to the biggest challenges faced by global healthcare today.

Ennov -

For this project, Ennov provided the solution to a US-based multinational health care company known for providing a broad portfolio of essential hospital products, including but not limited to: sterile IV solutions; infusion systems and devices; biosurgery products and anesthetics; pharmacy automation, software and services. Their global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. A worldwide employee network builds upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Ennov -

Maincare Solutions offers a full range of hospital administrative solutions which allow healthcare organizations to manage their activities in order to gain efficiency, optimize their resources and control quality and budget. The Maincare administrative suite is comprised of M-GAM for administrative management and invoicing, M-GELF for economic, logistics and financial management and M-RH for human resources and payroll management. Working on an accelerated timeline, Maincare Solutions was looking to add the capability to effectively manage patient financial and administrative documents to their administrative suite. To achieve this, they considered two alternatives—they could develop an Electronic Document Management (EDM) solution themselves (using market requirements to guide them) or they could partner with a company to provide them with a proven EDM solution that was currently operational for a significant number of client companies. Maincare Solutions also felt that any potential partner should be able to provide advice and guidance and ensure a good implementation of this specialized functionality. In the end, Maincare Solutions opted to select an OEM partner. This decision was strategic for Maincare Solutions as it allowed them to quickly respond to a market need while allowing their resources to maintain their focus on the development of their main solutions.

Court Square Group, Inc. -

Case Study: SAP S/4HANA Implementation Success Brings Penicillin Production Back to the United States. Migration and implementation of a robust SAP S/4HANA 1709 solution in just 16 weeks.

Court Square Group, Inc. -

Innovative Voice and Video Solution Captures Patient– Clinician Interactions and Clinical Data To Improve Clinical Trials Leading clinical management solution provider group taps Court Square to provide a 21 CFR Part 11 voice and video solution for rating patient–clinician interactions, using off-the-shelf tools.

Copyright Clearence Center -

The reuse of published material in medical communications projects is common practice but understanding how this activity intersects with copyright law can be confusing and fraught with misunderstanding that can lead to greater risk of infringement to your organization. Here are some common misconceptions around content access and reuse and guidelines for educating yourself — and your clients — on the responsible reuse of published content.

Copyright Clearence Center -

The role of Medical Affairs within a pharmaceutical or medical device company is largely centered around critical communications. Your reputation as a trusted, reliable source for both internal and external clients requires compliant access to comprehensive and up-to-date information via scientific and medical literature. If your organization doesn’t yet have a literature management tool, explore these reasons why implementing one will benefit Medical Affairs.

Copyright Clearence Center -

Reference management software provides immense value and time savings by automatically formatting citations. However, many reference managers were built for individual or academic use and may not meet the needs of those authoring in a corporate environment. Here are five key questions you may want to explore if your company is looking for reference management software. 

Copyright Clearence Center -

Whether just launching your information management strategy or looking to take yours to the next level, securing automated, centralized literature management software can maximize the value of your content investments, streamline companywide access to content, reinforce copyright compliance, and accelerate the flow of research to drive innovation. If you and your company have decided it’s time to invest in a literature management solution, here are the top questions you should ask when beginning your search.

Canopy Life Sciences -

At Canopy, we provide best-in-class MLR Solutions. Our 360° suite of services covering MLR Operations, Regulatory AdPromo Review, Medical Review, Consulting, and Technology is focused on one goal; keep content moving through the MLR process as quickly as possible, while driving quality, efficiency, and compliance. Our highly trained, agile teams work together across multiple regions, offering 24-hour global solutions supported by our internal people and processes, and driven by our desire to provide unparalleled service excellence.

Insight Guide -

Given the rapid evolution of AI, dedicating a person to staying abreast of AI developments is crucial to prevent it from becoming a distraction. This article underscores the pivotal role of an AI Operations (AI Ops) specialist in driving AI transformation within associations. The AI Ops role extends beyond technical implementation, fostering a cross-departmental team to collaborate, share learnings, and promote an AI-supportive culture. Through their work, the AI Ops specialist enables associations to utilize AI effectively, showcasing measurable results and achievements and ensuring a bright AI-driven future.