FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules

The eDRLS training modules deliver essential expertise for navigating FDA's electronic Drug Registration and Listing System.

The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your submission process.

Improving Patient Outcomes and Expanding Healthcare Access

Remote patient monitoring (RPM) is an excellent opportunity to create accessible healthcare that can not only enhance patient outcomes but also drive down strain and costs on the healthcare industry. Creating an RPM solution that communicates seamlessly and protects patient data can be a challenge, however, which is why KORE developed Connected Health Telemetry solutions for secure, encrypted communications that connect patient to provider.

Download the eBook, “Improving Patient Outcomes and Expanding Healthcare Access” to learn:

• The market and benefits of remote patient monitoring
• Key challenges and how to overcome them
• How KORE helped a Dexcom quickly launch an RPM solution 

Regulatory & MedicalAuthoring (RMA)Whitepaper

• Automated Initial Draft Generation Medical writers can auto-generate initial drafts using AIenabled templates.
• Large-Scale TFL Automation The add-in simplifies the integration of Tables, Figures, and Listings (TFLs). 
• AI-Powered TFL Summary Generation The add-in can automatically generate summariesof TFLs using AI.
• Enhanced Document Editing and Finalization A suite of tools supports tasks such as contentreuse, abbreviation list creation, tense conversion, and document comparison—helpingstreamline the finalization process.
• Human-in-the-Loop AI Interaction Users can engage with an AI chat assistant to guide specific tasks and monitor asynchronous AI progress.

Unlock Scalability Through High-Performing Technology

How confident are you that your organization has the right technology in place to support the journey from IND submission to commercialization?

Very confident? Somewhat confident? Not confident at all?

We can help!

Download our FREE Clinical Tech Stack Blueprint to get started on building out your systems to scale all the way from IND submission to Phase 3 trials: 

Not Just Any Trial: A Case for Sponsor-Specific Trial Finders

Not all trial finders are created equal. Study aggregate websites may seem patient-friendly, but they often introduce more risk than reward—for both patients and sponsors. Focusing on your own studies isn’t just safer; it’s smarter.

Download this report and uncover:

• Why sponsor-specific trial finders offer a more trustworthy, patient-centric experience
• The hidden risks of multi-sponsor aggregator platforms
• How leading sponsors are setting a new standard in trial discovery and engagement

The Last Mile of Patient Recruitment Social

If you're doing all the right recruitment outreach but your pre-qualified referrals are falling into a black hole and not converting into randomizations, this webinar is for you. Tune in as Gilead, Epic Medical Research, and ProofPilot unpack the complexities of the last mile of recruitment.

Optimize Clinical Trial Enrollment with ProofPilot's Scheduler

Playing phone tag is an unpaid, patient recruitment time-suck, draining up to 40 hours of sites’ precious time each week. 📞🏃‍♂️ Think about what freeing up 40 hours could do!

How do we give that time back to sites? Can we make things smoother for the patient, while we’re at it?

Technology can certainly help. ProofPilot’s automatic call scheduler eliminates the back and forth between sites and patients, reducing patient drop-off and increasing conversions. 

Ready for a deep-dive? Read our white paper to see how this technology transformed referrals for 42 sites!

Investigator Meetings and Site Training: A Necessary Evil, We Can Do Better

Site training holds a necessary place in clinical research, but the current framework lacks certain elements, hindering the true goals of successful training. What lessons can we draw from other industries that have demonstrated excellence and efficiency?

Imagine instead an alternative approach to ensuring quality conduct at the site that:

• Minimizes complexity and ambiguity with consistent approaches
• Prevents errors with highly-responsive, real-time feedback
• Takes the detective work out of finding information
• Fits the unique needs of site staff while also meeting compliance requirements

Read our latest white paper to explore a fresh take on site training that delivers on this imagined experience!

Recruiting Pediatric Patients for vaccine research

Evernorth® Health Services, collaborating with a contract research organization (CRO), performed direct-to-patient outreach to recruit patients for a pediatric vaccine trial to support a pharmaceutical sponsor. An incredible 700,000+ eligible patients within the age range were initially identified. After applying advanced analytics to narrow down to those most likely to qualify, households with multiple children were consolidated to maximize outreach efficacy.

Revolutionizing Regulatory Submissions: How AI Templates Simplify IND to NDA

Regulatory submissions are complex, but drafting them doesn’t have to be. What if you could generate structured, submission-ready content at the click of a button?

What You’ll Learn:

• How automation accelerates submission preparation – Reduce time spent on drafting and iteration from months to minutes
• How AI-powered templates enhance content generation – Instantly produce narratives, tables, and lists beyond static document structures
• How Weave simplifies regulatory workflows – Automate key steps from planning to publishing for greater efficiency and accuracy
• What’s next for Weave – Expanding support for clinical-phase filings, including CSRs, protocols, and annual reports

Hardware and Connectivity: KORE and JACS Solutions Relationship Simplifies IoT

KORE and JACS Solutions have developed a trusted, long-standing relationship with each providing strong service and solution offers that simplify the complexities of IoT.

For KORE, one of the primary hardware elements it offers its connected health customers is a USB modem that plugs into at-home cardiac rhythm monitoring devices to enable cellular connectivity.

OEM devices have limited shelf lives, which can lead to integration issues and continuity of services. For JACS Solutions, when their customers purchase hardware but need services such as connectivity, connectivity management, network monitoring, lifecycle management, or forward and reverse logistics they turn to KORE.

Medical Guardian Enables Seniors to Live Longer and More Independently with KORE

Medical Guardian is a leading provider of personal emergency response systems (PERS) and innovative health solutions for aging adults, with 600,000+ active members in all 50 states. The company offers a full suite of connected-care medical alert systems that empower older adults to live a life without limits and age safely at home.

KORE OmniSIM™ technology provides Medical Guardian the flexibility to wirelessly switch to a network carrier that best meets members’ specific needs. This revolutionary technology is designed to overcome cell signal challenges and address healthcare access disparities by enabling electronic switching of service carriers for optimal 24/7 connectivity.

Enterprise Mobility Meets Compassion: Curbing Substance Abuse Through Remote Monitoring

The opioid epidemic continues to present significant challenges to public health, with nearly 87,000 drug overdose fatalities recorded in 2024. And while this marks a decline from previous years, some states remain harder hit than others. West Virginia continues to face substantial challenges related to the opioid crisis. 

In response, a groundbreaking partnership between VeeOne Health, Social Mobile, and KORE has been instrumental in supporting drug control policy in West Virginia. Together, these organizations have deployed an innovative solution aimed at reducing relapse rates among individuals recovering from substance use disorder (SUD).

Optimizing Site Selection for Phase III Oncology Clinical Trial

Discover how a pharmaceutical company leveraged advanced analytics to streamline site selection for a Phase III oncology trial, ensuring efficient patient recruitment and high-quality data collection. Learn how integrating patient demographics, investigator profiles, and social determinants of health can enhance trial outcomes and accelerate drug development.

Upping the Migraine Intelligence Quotient: Real-world data sheds light on prevalence rates, providers and treatment variation

Discover groundbreaking insights into migraine prevalence, treatment variations, and healthcare provider dynamics with the PurpleLab Migraine Study. This comprehensive whitepaper leverages real-world data to illuminate the complexities of migraine management, offering valuable intelligence for healthcare providers and life sciences companies.

New Treatments Hold Significant Promise, but are Marketing Teams Helping Life Sciences Companies Deliver on this Potential?

Life sciences companies are operating in a new world, one where new treatments are being developed at breakneck speed, which holds unprecedented promise for patients. However, this new world is also one that requires the use of real world data (RWD) to empower marketing teams to effectively engage with various stakeholders – and ultimately lead healthcare providers to prescribe innovative drugs to the patients who will truly benefit from these treatment therapies.

How Deerfield Optimized Healthcare Advertising Campaigns Using Purplelab®’s Real-World Data Insights

Analyzing real-world data (RWD) in pharmaceutical marketing has the power to unearth hidden trends and insights into the overall prescription landscape. However, accessing and compiling this data tends to be a resource-intensive process. This case study explores how PurpleLab’s Prescription Measurement Report empowered the marketing agency Deerfield to harness RWD insights effectively.

How AI Can Drive Smarter, Faster Pharmaceutical Workflows

The pharmaceutical industry is evolving rapidly, but inefficient research workflows can slow innovation. With scientific literature growing exponentially and regulatory compliance becoming more demanding, AI is emerging as a transformative tool. 

This white paper explores how AI-driven solutions can streamline literature reviews, accelerate drug discovery, and enhance compliance, ultimately reducing time-to-market for critical breakthroughs. Learn how AI can automate tedious processes, improve data management, and provide real-time insights—allowing researchers to focus on what truly matters: advancing medicine. Dive in and discover the future of pharmaceutical research!

The Future of Systematic Literature Reviews

Introducing Literature Review by ReadCube

Systematic Literature Reviews (SLRs) help researchers and organizations navigate the growing sea of academic knowledge. Yet, traditional SLRs are slow, costly, and error-prone due to fragmented workflows.

What if you could transform your SLR process?

In The Future of Systematic Literature Reviews white paper, ReadCube introduces an AI-driven solution that streamlines workflows, reducing costs and improving accuracy. Discover the challenges of traditional reviews, the role of AI and automation, and how an all-in-one platform saves time and enhances efficiency.

Don't rely on outdated methods—download the white paper now!

A Case Study on How to Create and Integrate Multiple Research Libraries to Support Global Teams

Moderna, a leading mRNA technology company, saw unprecedented growth during the COVID-19 pandemic. Before this, its Medical Affairs teams aligned Research and Commercial narratives via a scientific communications platform (SCP) set annually with little change.

During the pandemic, daily data on the virus, its evolution, vulnerable populations, efficacy, durability, and real-world evidence (RWE) surged, overwhelming existing tools.

This case study explores how Moderna Medical Affairs used ReadCube’s platform as a centralized repository for efficient content management and integration, enhancing research accuracy, data efficiency, and collaboration.

Automation & AI in Medical Communications, Pt 2: Practical Applications & Case Studies

In Part 2 of our AI & Automation series, we delve deeper into practical case studies and real-world applications of AI in medical communications. Join Synterex as we explore the next phase of AI adoption, focusing on automating business processes, optimizing medical writing workflows, and leveraging AI for better stakeholder engagement.

Watch now to learn:
How to build a business information library for efficient content generation
The role of AI-driven automation in medical writing and regulatory documentation
Best practices for explaining AI adoption to stakeholders and clients
Examples of using automation to streamline business processes

Automation & AI in Medical Communications, Pt 1: Balancing Risk and Value

Synterex partnered with MarketBeam to host "Automation & AI to Solve Business Problems in Medical Communications" in June 2024.

Discover how AI and automation are transforming medical communications in this insightful webinar hosted by Synterex. From balancing regulatory risks to optimizing business practices, this webinar delves into the practical applications of AI across the medical writing landscape.

Watch now to learn:
How AI and automation can streamline medical writing processes
Best practices for AI compliance and governance
Real-world case studies on AI’s impact on business efficiency
Key insights into managing AI-driven risks in clinical and regulatory documentation

(White Paper) This One’s for the Children: Progress in Pediatric Drug Development in the United States

Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.

Download and read now for more insights!

(White Paper) The Road to Representation in Clinical Research

Innovative development of human drugs, biologics, and medical devices (medical products) and their quick advancement through the United States Food and Drug Administration (FDA) approval pipeline is necessary to improve the lives of patients. It is also imperative for sponsors to consider diversity when enrolling study participants throughout the clinical development pipeline to adequately represent the population of patients who have a disease or condition.

Download and read now for more insights!

The Business Benefits of Using FACTS for the Modeling and Simulation of Clinical Trial Designs

This white paper will explore the business benefits and case of using the FACTS simulation software for all your clinical trial designs.

Insife Annual Convention - Connect. Collaborate. Community.

Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.ect. Collaborate. Community.Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.

Series topic: Vigilance Medical Device Guidance Part 2: “Post-Marketing Safety Surveillance, EU & USA"

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! 

Series topic: Vigilance Medical Device Guidance Part 1- topic: “Vigilance Medical Device Regulations (EU) 2017/745

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! 

HALOPV - transforming the management of the Pharmacovigilance System Master File (PSMF)

The PSMF document is a compulsory and vital part of pharmacovigilance compliance in Europe, supporting and documenting a company’s compliance with the requirements laid down in EU legislation. Each pharma company has to have such a file, fully describing their PV system. It must be kept up to date and must be available within seven days on request if the EMA wishes to view it. As well as describing the company’s PV system, the PSMF includes annexes with up-to-date information on topics such as ongoing and completed clinical trials, registered products and audits.

The PSMF holds a large amount of important information and the variety of the information included means that all the information is rarely managed by the QPPV themselves, who maintains oversight and is responsible for the PSMF itself. The content might be provided by different personnel, from regulatory affairs, quality assurance or clinical development. Therefore, it is essential that the communication between these personnel and the QPPV is as seamless and transparent as possible.

Reducing the need for manual effort

The coordination of the material required for the PSMF used to be a highly manual endeavour. People would work with document management systems and the QPPV Office would have to manage multiple email exchanges and spreadsheets, in order to track who was providing what information and what had been sent through, then chasing what was needed. They then had to create a common format for all the information received so it could all be pulled together cohesively. Companies are updating this information at least on a quarterly basis and the bigger the company, the bigger the headache to collate everything correctly and on time.However, the technology used and developed for Insife’s revolutionary HALOPV system has now automated this process, saving effort, time and therefore money.

Templated for ease and consistency

The data sent through each annex is of course from different sources and systems, but HALOPV has an interface with other systems which identifies and uploads just the information that is needed, yet again eliminating excessive manual work. There are also templates for each annex so that once all the information has been uploaded from the different sources, it is all presented with the same look and feel. This makes it much easier to have a full oversight of all the content and be able to review it as needed.

All the annexes in the PSMF can be auto-scheduled, with notifications being sent out directly to the responsible person for each section of content. The system can also take away the need for ongoing manual tracking and follow up, with reminders being sent out automatically too. Based on our experience, the man hours saved can be substantial.

 It all starts with implementation

The key to a successful use of the PSMF module is the detailed work undertaken at implementation. Agreeing on the annexes and who will deliver the content for each is of course essential. While the QPPV is the person responsible for the PSMF, the responsibility of maintaining it may be delegated to a member of the QPPV Office. This depends on the size of the company and its internal structure.

The structure and working practices of each company also means that certain things in the Insife system need to be adaptable. There are templated workflows within the PSMF module, but they can be configured differently to make the module work in the most efficient way for each and every client.

The other crucial part of the implementation is of course the decisions on where the data are coming from and in what format. It could be emanating from five or six different IT systems in different departments, so agreement on formatting is key at this stage.

The future - globalising the PSMF

The EU’s PSMF legislation was set in 2010 and there are moves to create similar processes globally. Already, the UK (post Brexit), Turkey, India and Saudi Arabia have implemented their own requirements and others are following. There are challenges when looking at local and regional requirements as the varying regulations undoubtedly lead to logistical challenges. Insife are jumping to this challenge by providing options to create similar solutions for other countries. The key is to create rules that determine when the same information is required for other territories, so that replication of information is minimised and key data are shared as necessary.

HALOPV – the solution for future proofing your PSMF!

With the proven technology at the heart of HALOPV and the success of the PSMF module, Insife is in a perfect position to work with companies and regulators alike, to make the PSMF as seamless and efficient as possible, right across the globe.

The Global Regulatory Intelligence Club for Pharmacovigilance

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

AI solution in case intake

Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.ect. Collaborate. Community.Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.

A Business Case for a Document Comparison Software: The Best Insurance Policy for Regulatory Affairs

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? 

Barcode Compliance Guide

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?

e-Labelling: The Road to Reduced Med Device Packaging

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.

Testimonials: What will DIA Membership Offer You?

What is ReadCube?

ComplianceAuthor® AI

Redefining Content Management with Component Content Management Systems (CCMS)

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.

Enhancing Compliance and Efficiency with Structured Content Authoring

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?

Canopy MLR Solutions

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.