Life Sciences Archive - Page 3 of 13

Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

by David Gwyn | May 31, 2024 | Business Consulting, Datasheet, Life Sciences, Regulatory

Regulatory Information Management (RIM) remains critical in today’s ever-evolving pharmaceutical industry. It involves maintaining licensure across countries and publishing the necessary information for health authority approvals. Selecting the right RIM package isn’t just about integrating technology; it’s about ensuring the solution meets complex business requirements and gains widespread user acceptance. This is where fme steps in, employing a meticulous approach to guide companies through the RIM package selection and evaluation process.

1. Understanding the Complexity of RIM

Regulatory Information Management manages and publishes licensure information across multiple countries. As such, purpose-built solutions tailored to these unique demands are required. fme recognizes this need and offers services that understand the intricacies of RIM and the integration challenges with existing software stacks.

2. fme’s Approach to Software Selection

fme’s approach is characterized by a systematic methodology designed to capture both current and future requirements of RIM and publishing. Here’s how we do it:

Define Requirements: Before proceeding with solution selection, we work closely with clients to define their current and future RIM requirements, ensuring that any solution aligns with their business objectives.
Identify Candidate Solutions: Leveraging our industry expertise, we identify potential solutions that could integrate well with the client’s existing software stack.
Drive Evaluation and Selection: Through a series of evaluations, we ensure that all critical voices from the user community are heard, ensuring that the solution meets technical requirements plus user needs and preferences.
Support Decision Making: We assist clients in the final decision-making using quantitative and qualitative measures to compare potential solutions.

3. Engaging Key Client Team Members

A unique aspect of our approach is the emphasis on stakeholder engagement. We understand that for any solution to be successfully adopted, it must receive widespread acceptance from its end-users. Therefore, we:

Organize Requirement Gathering Sessions: We facilitate sessions with various stakeholder groups to ensure all needs and concerns are captured.
Promote Participation in the Selection Process: From defining requirements to evaluating demos and participating in hands-on pilot tests, we ensure key client team members are actively involved in every step.

4. Ensuring a Tailored Fit

Our methodology doesn’t just stop at selecting a package; it ensures the solution is tailored to the client’s organization. This includes:

Building the Business Case: We help clients articulate the strategic objectives and analyze financial implications, ensuring the solution delivers value.
Narrowing Down Vendors through RFI/RFP Processes: We ensure that only the most suitable vendors are considered through a structured RFI and RFP process.
Testing the Solutions: We ensure the solution meets the listed requirements and works seamlessly in the client’s real-world environment through scripted demos and client-driven pilot tests.

5. Finalizing the Selection

The final stage involves a comprehensive vendor assessment, looking at financial stability, product roadmap, and customer references. This thorough analysis ensures the final decision is well-informed and geared towards long-term success.

Learn More

For more details about fme SelectAssist, and how it can benefit your organization download the SelectAssist for RIM datasheet, and contact us to discuss your current challenges.

Download Datasheet

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in RIM package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your RIM package selection is a resounding success. Join us in navigating the complexities of RIM, and let’s ensure your regulatory information management is robust, compliant, and efficient. Contact us today to get started.

Join fme in Madrid at the Veeva Summit R&D and Quality

by The fme Team | May 3, 2024 | dqMan, Events, Life Sciences, migration-center, Veeva

Veeva Product Certified Silver Partner Badge

The 2024 Veeva Summit: R&D and Quality for clients and partners is around the corner, and fme has once again selected as a Gold sponsor. Only a select group of certified partners are invited to participate, and we are honored to be able to share our experience and strategies with the Veeva community. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Veeva Summit for European Clients

The Veeva Summit in Madrid is the continent’s best opportunity to learn the crucial R&D and Quality best practices and solutions for content management, as well as network with industry professionals from leading Life Sciences firms. Since fme specializes in providing Life Sciences firms with implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support this powerful platform throughout an organization that is ready to leverage the power of advanced technology.

This year’s Veeva Summit promises to deliver unique value to attendees:

Gain insights into the latest features and enhancements within Veeva’s powerful platform, and how they help you reach your IT and business goals.
Understand how fme provides end-to-end solutions to optimize your Veeva environment, ensuring seamless integration, operation, and maximum ROI.
Exchange ideas, network, and learn from industry professionals to help you stay ahead of industry trends and competition.

fme at the Veeva Summit

The Veeva Summit is a valuable learning opportunity. fme’s Life Sciences experts will be answering questions, demonstrating our capabilities, and proving how our experience and innovation can bring your organization to new heights. Here are a few solutions designed to deliver exceptional benefit to our Veeva clients:

Migration Planning and Execution – Good content in, good content out – get it right from the beginning. fme’s technical experience, business process knowledge, and proprietary tool migration-center make us an unsurpassed choice to migrate your content into the Veeva platform, consolidate legacy platforms, or migrate data Vault to Vault. Learn more >>
fme migration-center – fme’s proprietary migration-center solution can save you 60% in costs and 80% in project duration compared to developing your own scripts and frameworks. Learn more in our migration-center for Veeva datasheet >>
fme dqMan Veeva Vault Edition – Based on VQL and MDL, dqMan provides exclusive capabilities and a broad feature set designed to boost productivity and maximize efficiency by eliminating manual, time-consuming tasks. Learn more >>
fme HealthCheckAssist – Personalized roadmap to Veeva success. HealthCheckAssist provides an in-depth assessment of your current configurations and usage of your Vault RIM solution, then delivers a detailed report containing recommendations and a clear roadmap to optimize and improve the use and value of the platform. Learn more >>
fme PlatformAssist – Keep your Veeva platform delivering top performance and value. PlatformAssist is a comprehensive set of modular building blocks that ensure you are at your best through updates, process flow customizations, and daily support issues post go-live. Learn more >>
fme SelectAssist – Life Sciences companies face many challenges when selecting new software solutions and platforms. SelectAssist is designed to gather and consolidate requirements, incorporating the perspective of end users, technology requirements, and business goals. We then evaluate solutions and make recommendations for solutions that will meet complex business requirements and gain widespread user acceptance. SelectAssist simplifies software selection for you. Learn more >>
fme MetatdataAssist – Effortless metadata updates. Whether before a migration or within an existing repository, MetadataAssist uses advanced AI and NLP (Natural Language Processing) to reconnect lost documents without the frustration, time, or costs to your key business resources. Quickly and efficiently update your content’s metadata to ensure they are properly classified and discoverable in your Veeva system. Learn more >>

Even if you aren’t attending the Veeva Summit, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

fme's Veeva Capabilities

Contact Us Today!

To learn how fme has earned their place as an end-to-end Veeva partner and to get more details on the conference, contact us today. We’ll schedule a discovery meeting with our Veeva experts to discuss your current challenges and introduce the range of next steps that can accelerate your journey to success.

Maximizing the Veeva Platform for the Whole Suite of Regulatory Use Cases

by Frank D'Entrone | Mar 11, 2024 | Life Sciences, Technology Services, Veeva

There are numerous reasons why Veeva Vault has become a popular strategic platform for regulatory information management (RIM) and more–from its easy accessibility and scalability in the cloud, to its regular updates adding new innovative functionality.

However modest or ambitious Life Sciences companies’ plans to harmonize Regulatory content and standardize and streamline processes may be–potentially spanning adjacent functions such as Quality and Clinical operations–Veeva perfectly supports all scenarios with built-in futureproofing.

Common RIM Challenges

Life sciences companies often face several challenges in Regulatory Information Management (RIM) due to the complex nature of regulatory requirements, data management, and the need for compliance across different regions. A software solution such as Veeva Vault RIM can help address these challenges by providing streamlined processes, centralized data management, and compliance support. Here are a few of the common challenges that life sciences companies expect a RIM software solution to help address:

Complex Regulatory Requirements

Navigating the complex global regulatory landscape is challenging. Companies expect RIM software to provide updates on regulatory changes, guidelines, and standards to ensure compliance. The software should enable easier adaptation to regulatory requirements across various regions and countries.

Data Integration and Accessibility

Life sciences companies often deal with vast amounts of data from diverse sources, including clinical trials, research data, and regulatory submissions. A RIM solution should offer seamless data integration across various platforms and ensure that information is easily accessible, well-organized, and securely stored. This includes managing a wide range of document types and formats.

Efficient Submission Management

Preparing and managing regulatory submissions is a time-consuming process that involves compiling, organizing, and submitting large volumes of data. A RIM solution should streamline the submission process, provide templates and guidance for different types of submissions, and ensure that all documentation meets the specific regulatory standards of each region. The software should also allow tracking of submission status and deadlines to avoid compliance issues.

Collaboration and Communication

Collaboration among various departments and stakeholders is crucial in the regulatory process. RIM software should facilitate effective communication and collaboration by providing tools for project management, document sharing, and version control. This ensures all team members work with the most up-to-date information and can easily track changes and approvals.

Compliance and Risk Management

It is paramount to ensure compliance with regulatory requirements and minimize risks associated with regulatory actions. RIM software should offer robust compliance and risk management features, such as audit trails, compliance checks, and alerts for potential issues. This helps companies proactively address compliance risks and maintain a state of continuous regulatory readiness.

By addressing these challenges, RIM software can significantly improve the efficiency and effectiveness of regulatory processes, reduce the risk of non-compliance, and ultimately accelerate the time to market for life sciences products.

Veeva in a Regulatory Context

Veeva RIM (Regulatory Information Management) is a comprehensive suite designed to help life sciences companies manage their regulatory processes more efficiently. Here’s how Veeva RIM supports addressing the challenges mentioned:

Adapting to Complex Regulatory Requirements

Veeva RIM provides a unified platform for tracking regulatory requirements across different regions and countries, ensuring that companies can easily adapt to various regulatory landscapes. It includes regulatory intelligence features that offer insights and updates on the latest regulatory guidelines, helping companies stay compliant.

Streamlining Data Integration and Accessibility

The software offers a centralized repository for all regulatory documents and data, enabling easy access and management of information. It supports integration with other systems and platforms, ensuring that data is harmonized and efficiently retrieved, enhancing data accessibility and integrity.

Enhancing Efficient Submission Management

Veeva RIM simplifies the submission process through automation and structured workflows. It provides tools for creating, compiling, and managing regulatory submissions, including templates and checklists that align with specific regulatory requirements. The system also tracks submission statuses and critical deadlines, ensuring timely and compliant submissions.

Facilitating Collaboration and Communication

The platform enhances collaboration among internal teams and external partners. It offers document sharing, version control, and project management tools that enable effective teamwork and ensures all stakeholders are aligned and informed. This collaborative environment helps streamline the regulatory process and reduce errors.

Proactive Compliance and Risk Management

Veeva RIM includes risk management and compliance monitoring features, such as audit trails and automated compliance checks. These tools help identify potential compliance issues early and enable companies to take corrective actions promptly, reducing non-compliance risk and enhancing regulatory readiness.

By providing these capabilities, Veeva RIM addresses the critical challenges faced by life sciences companies in Regulatory Information Management, helping them to navigate the complex regulatory environment more effectively and efficiently.

fme & Veeva: Securing your RIM platform’s ROI

In conclusion, Veeva Vault’s RIM solutions address life sciences companies’ multifaceted challenges in regulatory information management. By providing a unified platform that adapts to complex regulatory requirements, streamlines data integration, enhances submission management, and facilitates collaboration, Veeva Vault empowers organizations to navigate the regulatory landscape efficiently.

fme is crucial in helping clients maximize their ROI in Veeva Vault. With expertise in data migration, deduplication, and enrichment, fme ensures that life sciences companies have a harmonized platform that serves as a single source of truth for regulatory information. fme’s comprehensive business consulting and strategic technical advice, coupled with its experience in system implementation and migration in regulated industries, enable clients to optimize their RIM environment’s performance. Furthermore, fme’s ability to lay out future-stage strategies for digital process transformation extends the benefits of Veeva Vault beyond the regulatory function to adjacent departments, driving the best possible outcomes and ensuring a significant return on investment.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and discuss a specific requirement relating to Veeva Vault-based RIM.

Download our Veeva Capabilites Datasheet

Related Resources

Optimize and Improve Your RIM System with HealthCheckAssist℠

by David Gwyn | Mar 6, 2024 | Business Consulting, dqMan, Life Sciences, Veeva

Regulatory compliance is more complex and crucial than ever, and organizations are under immense pressure to manage their regulatory information efficiently. In addition, the stakes have increased as health authorities responding to public pressure have become increasingly rigorous in their evaluations, issuing more fines and penalties than ever. The health authorities are also striving to standardize data submissions in ways that organizations may not be ready to meet.

Common Regulatory Challenges

Organizations face numerous immediate challenges in managing regulatory information:

High volume of data and documents
Data fragmentation over time and platforms
Adherence to evolving standards
Inefficient processes across teams
Compliance risks
Legacy systems being consolidated into new platforms
Frequent RIM platform updates to stay current with complex and changing regulatory environments from multiple Health Authorities worldwide

As companies grow, merge, and acquire new data, many struggle to maintain operational efficiency and ensure compliance with mission-critical global regulatory requirements.

Modern Platforms: A Double-edged SaaS

There’s no question that today’s cloud-connected SaaS solution platforms are a fantastic leap forward in technology. Unfortunately, their undeniable benefits also come with their own challenges that IT teams need to be prepared to address.

For example, today’s leading platform in regulatory information management Veeva introduces three product releases per year where the RIM Vault is enhanced with new features. Compared to historic on-prem solutions that started to become out of date the month after purchase, this is a fantastic capability. The challenge now is that new features, bug fixes, and enhancements are automatically turned on and/or configurable and have a critical go-live date regardless of whether the organization is ready. The volume of changes can be significant, and some organizations fall behind in implementing the configurable features. In addition, many configurable features are not immediately beneficial but are utilized to build a foundation for future innovations that provide additional efficiencies.

Security can be another significant challenge. An overly complex security scheme can stunt the utilization of the solution, preventing the use of features and functionality intended to provide significant user efficiency. A properly configured and maintained RIM solution should allow all its users to easily find the information necessary to complete current Regulatory tasks. Often, during solution implementations, an organization will try to configure a security scheme that is far too granular, complex, and not conducive to efficient collaboration. The overly complex security will cause frustration and loss of user adoption of the solution. It can also cause burdensome administrative overhead and limit the available scope of change requests from the user community.

The Solution – HealthCheckAssist

Implementing your RIM solution took time and money. As an experienced regulatory information management solution provider and proven migration, technology, and services partner on the Veeva platform, fme is ready to help our clients make the most of their investments. We are proud to introduce HealthCheckAssist, a comprehensive service solution meticulously designed for users of Veeva Vault RIM.

In the often-convoluted landscape of regulatory information management, HealthCheckAssist is a surgical toolbox of optimization, offering a suite of services tailored to dissect and enhance the intricate mechanisms of Vault RIM. Through in-depth stakeholder interviews and system analysis, HealthCheckAssist delves into different departments’ unique needs and challenges to develop a complete streamlining and optimization pathway that aligns perfectly with organizational objectives.

In the dynamic environment of regulatory information management, features and functionalities evolve rapidly. A standout feature of HealthCheckAssist is its rigorous review of new feature capabilities. This ensures that your organization remains at the forefront of the latest changes, leveraging the latest updates to streamline processes and enhance efficiency.

Moreover, HealthCheckAssist strongly emphasizes manageable security, with comprehensive assessments to safeguard critical regulatory data, ensure proper accessibility, and promote effective information exchange and collaboration. Shifting the focus to a manageable and sufficiently open security model is a cornerstone of any robust regulatory information management strategy. Properly executed, this security approach eliminates over-engineered access schemas and protects your information and users in an age where data breaches can have catastrophic consequences.

Benefits of HealthCheckAssist

The benefits of HealthCheckAssist are multifaceted. Organizations can expect a significant uplift in data and document quality, driven by optimizing the features and functionalities of Vault RIM. This enhancement in data and document quality is not just about accuracy; it’s about ensuring that your regulatory information is comprehensive, up-to-date, and readily accessible, facilitating swift decision-making and compliance processes.

HealthCheckAssist also includes access to fme’s unique professional administration tool for the Veeva platform, dqMan. With dqMan, HealthCheckAssist dramatically reduces the need for manual intervention and automates and optimizes key processes to free up valuable resources. Your team can focus on strategic initiatives rather than getting bogged down in routine data and document management tasks. This shift boosts productivity and enhances job satisfaction among team members, who can engage in more meaningful and impactful work.

The strategic advantage offered by HealthCheckAssist cannot be overstated. In the competitive regulatory compliance landscape, staying ahead requires keeping pace with regulatory changes and preempting them. HealthCheckAssist empowers organizations to do just that, providing a competitive edge that can make all the difference in a competitive and highly regulated industry.

Conclusion

HealthCheckAssist by fme is not just a solution; it’s a strategic partnership in your journey through the complexities of regulatory information management. Its comprehensive suite of services focuses on optimizing Vault RIM and make it an indispensable tool for any organization looking to excel in regulatory compliance.

We invite you to contact us to learn more about HealthCheckAssist’s transformative potential for your organization. Discover how it can streamline your regulatory information management processes, enhance both data and document quality, and provide a strategic advantage in the fast-paced world of regulatory compliance.

Download the HeathCheckAssist Datasheet

Added Bonus – Veeva Vault Edition of dqMan

As an additional bonus, we will also include a single-user annual license for dqMan as part of the engagement.

dqMan is a professional administration tool designed to boost productivity and maximize your efficiency as a Veeva Vault expert. Carefully crafted on the robust dqMan platform, this tool reveals the true power of the VQL (Vault Query Language) and MDL (Metadata Definition Language). It provides users with exclusive capabilities and a broad feature set while enhancing user accessibility and streamlining operations alongside the comprehensive functionalities offered by Veeva Vault Admin. Seamlessly installable on any Windows machine, our enterprise-grade software solution boasts an intuitive user interface, delivering a great user experience.

Say goodbye to manual, time-consuming tasks and focus on what truly matters—efficiently managing your Veeva Vault applications.

Seamless Integration: Transforming CRO to Sponsor Data Transfers with fme and JiT

by David Gwyn | Feb 5, 2024 | Business Consulting, Life Sciences

In the dynamic realm of clinical research, the partnership between fme and Just in Time GCP (JiT) emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File (TMF) management in clinical trials.

The inception of CROAssist™ is a testament to the forward-thinking approach of both JiT and fme. JiT brings to the table its unparalleled expertise in risk-based TMF management approaches, which are crucial for maintaining compliance and ensuring inspection readiness. On the other hand, fme contributes its vast experience in system migrations, a critical aspect in the seamless data transfer across platforms.

Automated Transfer of Trial Data from CRO to Sponsor

The core of CROAssist’s innovation lies in its ability to automate the transfer of trial data from Contract Research Organizations (CROs) to sponsor systems like Veeva Vault eTMF. This automation is a game-changer, addressing the traditional pain points of TMF management, such as data integrity, standardization, and compliance with regulatory standards. By minimizing human intervention, CROAssist significantly reduces the risk of errors and inconsistencies, ensuring that the TMF is always audit-ready.

Beyond automation, CROAssist stands out for its comprehensive TMF strategy. It’s not just about transferring data; it’s about transforming how it is managed, analyzed, and utilized. The platform employs sophisticated algorithms and artificial intelligence to enhance data integrity and compliance. These advanced technologies enable a proactive approach to TMF management, identifying potential issues before they become significant problems.

Benefits of CROAssist

The benefits of CROAssist extend beyond operational efficiencies. By streamlining TMF management, the platform enables sponsor organizations to focus more on the scientific aspects of their trials, rather than being bogged down by administrative tasks. This shift in focus can lead to faster trial completions, quicker time-to-market for critical medications, and ultimately, a more significant impact on patient health.

The partnership between JiT and fme, culminating in the creation of CROAssist, is a reflection of a broader trend in the pharmaceutical industry towards collaboration and technological innovation. In a sector where the stakes are incredibly high, with patient health and safety at the forefront, such innovations are not just welcome; they are essential.

The significance of CROAssist goes beyond its technical capabilities. It represents a paradigm shift in TMF management, where technology and expertise converge to create a more efficient, reliable, and compliant clinical trial environment. As the industry continues to evolve, partnerships like that of JiT and fme, and solutions like CROAssist, will be critical in navigating the complexities of clinical research, ensuring that life-saving treatments can be delivered to those in need more swiftly and safely than ever before.

QUICKFACTS

Efficient TMF Management: Automates and streamlines Trial Master File processes.
Management: Seamlessly coordinates data between sponsors and CROs.
Integration with Veeva Vault eTMF: Ensures validated data import for enhanced integrity.
Operational Burden Reduction: Alleviates complex TMF tasks from businesses.
Scalable Solution: Adapts to varying trial sizes and complexities.

In conclusion, the collaboration between JiT and fme and their development of CROAssist is a shining example of how strategic partnerships and technological advancements can address longstanding challenges in clinical trials. As this partnership continues to bear fruit, the industry can look forward to a future where TMF management is no longer a hurdle but a facilitator of scientific discovery and medical breakthroughs.

Learn More About CROAssist

Whether you are a sponsor or a CRO, the efficiency and accuracy gained through CROAssist will streamline your data transfer and minimize the obstacles to your trial’s success. Learn more at the SCOPE Summit for Clinical Trial Executives, or contact us directly to get all the details on CROAssist and how this new approach to TMF management can benefit your patient health and business goals.

Download Datasheet

Will we see you at DIA RSIDM 2024?

by The fme Team | Jan 18, 2024 | Business Consulting, ECM, Events, Life Sciences

Will you be attending DIA RSIDM 2024 in Bethesda, MD in February? This annual event is the premier gathering for professionals working in the pharmaceutical, biotechnology, and regulatory industries, focusing on the critical aspects of submissions, information management, and document compliance.

The importance of operational efficiency across the full process and technology environment that enables the management of regulatory information cannot be understated. It is vital to provide timely, quality regulatory submissions to health authorities in order for drug companies to accelerate the delivery of therapeutics and vaccines to their patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders collaborate to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology.

If you’ve attended in the past, the 2024 Forum includes a refreshed set of tracks and focus areas that will provide invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. You’ll also have ample opportunities for networking, knowledge sharing, and education for both business and technology-focused topics at all levels.

Connect with fme’s David Gwyn at DIA RSIDM 2024

This year, fme’s own VP of Business Consulting David Gwyn will be attending DIA RSIDM @presenting and contributing to the many discussions with industry and regulatory stakeholders covering the effective strategies to align related people, processes, and technology for business success.

Use the contact form below to get connected before the event, or make plans to join his session on February 14:

Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
View Session >>
Feb. 14, 8:30am
Bethesda North Marriott Hotel and Conference Center
Brookside (Lower Level)

Other Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are worth the time to attend. Hope to see you there, and let us know if you have any questions on these topics!

Fostering Trustworthy and Responsible AI
View Session >>
Keynote Address
New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations.

The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
View Session >>
Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
View Session >>
Enable high-quality relationships between clients and vendors in the regulatory submissions space, and successfully shifting from a vendor-based RIM model to an in-house operation. We will also delve into acquisitions and mergers/partnerships as they relate to strategy and execution in submissions operations.

So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
View Session >>
The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. This session will discuss how applying a software-agnostic methodology can supports effective content transformation across people, processes, technology, and data/content.

We are excited to participate in these valuable conversations with regulatory thought leaders, and re-connect with industry colleagues! Find the full schedule here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

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