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

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

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.


  • 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.

Will we see you at DIA RSIDM 2024?

Will we see you at DIA RSIDM 2024?

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
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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!

Life Science Insights: Build a Platform Roadmap

Life Science Insights: Build a Platform Roadmap

The traditional ‘best of breed’ approach to departmental systems in Life Sciences is losing popularity. That’s as a more comprehensive ‘platform’ approach enables greater flexibility, adaptability, and interoperability including data sharing. But change can feel onerous so it’s important to develop a strategy that’s both future proof and non-disruptive to your organization. fme’s professional services team can help you strike the right balance.

All organizations are striving to be more agile, productive, and cost-efficient, and none more so than those in the Life Sciences industry where the pressure to adapt and change is constant. And as long as individual business functions, such as Regulatory, Clinical, Quality, and Safety, continue to operate in silos using their own systems, data and document formats to fulfil their respective business processes, costs and complexity will increase rather than diminish.

Challenging the status quo can feel daunting, but Life Sciences organizations have limited choice about this. For many years, the ‘best of breed’ approach to deploying technology promised organizations optimal functionality as well as protection from single-vendor point of failure. But as data exchange and flow between teams and external parties (such as Regulatory agencies and outsourced partners) has grown in strategic importance, the pressing priorities now are platform and data standardization, simplification, and unification. A single, holistic platform approach is also ultimately easier and more cost-efficient to run and manage.

That’s not to say that any one software vendor has 100% of the functionality a Life Sciences company needs. The leading platform players, with a well-established end-to-end business capability, probably get close to ~90% while supporting the integration of peripheral elements such as submission publishing or specific IDMP components to provide full coverage.

This offers companies something to aim for, even if they do this incrementally via a phased approach.

Triggers for change: M&As,  persistent pain points, new regulations

The best roadmaps for digital transformation allow for steady, manageable progress toward a simpler and more flexible future, while delivering (relatively) easy wins along the way.

There are many triggers that can initiate a technology change.

  • A company merger inspires a more modern IT solution stack
  • The incoming company in an acquisition has a mature business application platform and business process
  • New industry regulations compel function-specific changes that are too onerous to apply

When these opportunities present themselves, the important thing is not to make another siloed decision, but to work toward a more modern, harmonized, and agile future state.

For instance, if Regulatory demands are becoming overwhelming, platform-based transformation could start here – applied initially to registrations (core data about licensed products), and archived submissions (aligned to that data). A next phase can then progress to content authoring, review, and approval process management.

Once Regulatory processes have been migrated to a modern cloud platform, companies can look to prepare Clinical, Quality, and Safety data and business processes for migration to the same core platform. Then each can access and add to the same core/master data set – enabling a unified platform.

One of the powerful benefits of tackling platform-based system modernization incrementally is that it presents the chance to bring people along on the journey. Teams have to opportunity to learn what works and what doesn’t, and refine features, processes, and capabilities along the way.

To ensure that any new system- and data-based decisions move the company in the right direction, and reap maximum returns, it’s important to be methodical in setting and following a strong overarching platform strategy.

We recommend:

  • Establish the right mindset and gain leadership commitment and buy-in to a long-term platform-based technology and data management strategy.
  • Start with a thorough ‘Phase 0’ assessment and gap analysis across the interlinked lines of business (Regulatory, Clinical, Quality, and Safety) to establish what’s possible and the level of work and investment that will be needed. This process could take 6+ months, depending on the size and complexity of the organization and its portfolio, and the current level of digital maturity.
  • Bring in the right talent, both externally in terms of vendor and systems integrator/IT services support, and internally so that there are subject matter experts on the client side. These SMEs are essential to work with external providers to help confirm an appropriate roadmap and determine the investment in time and skills that will be needed on both sides to ensure success.

Benefits of a platform roadmap

A strategic platform roadmap will provide substantial guidance and benefits over time. With the support of an established modern, cloud-based platform, business functions will start to behave like well-oiled machines, optimized in their process management and ability to re-use the latest data on demand. Because cloud-based platforms are updated frequently, teams will be ahead of and less reactive to changes such as Regulatory updates as these continue to occur in the interests of patient safety and enhanced patient experiences.

The same goes for scope to add new functionality and incorporate the latest technology advances. A recent example is the emerging capability of AI solutions at they become more accessible, relevant to, and proven in Life Sciences processes.

Additionally, phased approach to modernization, as part of a longer-term single-platform strategy and roadmap, means that the business will encounter minimal disruption. There is an opportunity to socialize, mature and optimize new functionality so that it works well for everyone. Crucially, no new and costly legacy dead-ends will be created.

How fme can help

fme’s team of Life Science experts can support the entire end-to-end digital transformation experience. This starts with providing deep Life Sciences industry-specific business and IT deployment experience and best practice guidance to help shape the right long-term platform strategy via our Business Consulting team. We then provide full technical implementation, integration, and comprehensive migration services supported by a rich toolkit of solutions accelerators that are exclusive to fme.

We are a client-focused provider dedicated to your success. We partner with all of the major Life Sciences platform solution providers, so we are able to provide recommendations and services that meet the unique needs of your company with the most effective solution, and work in partnership with your own IT team.

Once the new platform is live, we also provide an intense ‘Hypercare’ package combining full business, technical and administrative support, as well as appropriate change management and training. Finally, we provide exceptional post-implementation managed services with fme PlatformAssist™ to maintain your environment through application updates, process improvement and daily support.

To learn more about our full range of services, and to discuss your specific requirements, contact us today. We’d love to help you establish your long-term roadmap to technology and business success.

Health wearables: Delivering value & compliance from medtech innovation

Health wearables: Delivering value & compliance from medtech innovation

From continuous diabetes monitors to wearable blood pressure gauges, smart hearing aids and Wearable Cardioverter Defibrillators (WCDs), academic spinoffs and medical technology startups are devising a whole host of intelligent aids to keep patients safe and improve their quality of life. But getting products to market and developing a robust exit plan relies on responsible teams being ahead of regulatory demands.

The market for smart medical consumer devices, already worth tens of billions of dollars annually, is growing and evolving sharply. These devices, also known as “wearable health tech” or “medtech devices”, are products designed to monitor and manage various aspects of an individual’s health and wellness. This includes fitness trackers, smartwatches with health monitoring features, connected scales, blood pressure monitors, glucose monitors, and more.

The rising popularity of such products is the result of a number of converging developments. First, people are becoming more conscious of their health and are seeking ways to monitor and manage it themselves – they see the potential to use technology to keep themselves well. Continued growth in fitness tracking and wellness monitoring has driven the demand for devices that can provide real-time data on activity levels, sleep quality, heart rate, and more.

At the same time, huge advances in smart digital capabilities (including connected sensors), and easier access to advanced data capture and AI-enabled analytics (e.g. cloud-connected devices), have finally made these devices technologically possible. Many wearable health devices are designed to sync with smartphones, so users can track their health data conveniently and receive personalized insights.

But all of this smart technology needs to be reliably enabled, and regulated to ensure patient safety.

Regulatory Requirements for Medtech Innovation Companies

Many of the latest medtech innovations are coming out of academia, young biotechs or incubation hubs. For these creative, science-led teams, it can be quite a leap to progress from having a promising idea for a new wearable device and coordinating its manufacture to bringing a compliant product to market, to preparing a viable business entity for sale.

When most of the strategic focus is on the innovation, and on the potential impact on patient outcomes and quality of life, it can be easy to overlook the systematic rigor and data housekeeping that will set the venture in good stead and smooth the new device’s path through licensing approvals and/or due diligence as part of an exit plan.

Starting off on the right foot is always advisable. It’s vital to ensure that initial “make-do” practices don’t have to be unraveled later in favor of something more robust, consistent, and compliant with the demands of regulatory bodies in current and future markets.

Put another way, it is never too early to adopt established industry best practice. This includes implementing an appropriate regulatory information management (RIM) system or platform that can keep the right records of product detail, in a format that is compatible with the requirements of health authorities.

Collecting data and structuring it correctly is a critical first step. Providing meaningful insights to users is important too, which means having access to appropriate algorithms and software that can analyze the collected data and present it in a way that is comprehensible and actionable. Other challenges for manufacturers include differentiation in a growing market that is attracting a lot of attention. The sooner developers can bring their products to market, the greater their chance of securing commercial advantage.

Addressing these market preparation challenges requires a multi-disciplinary approach. This will need to combine expertise in medical technology/electronics, the optimal user experience, regulatory affairs, appropriate software selection, and compliant data capture and management.

How fme Can Help

As a Life Sciences data and technology service specialist and business consultancy, fme is ideally positioned to help smart medical devices developers ready their propositions for market; or for sale to an investor or commercial entity.

From initial strategic consultancy, regulatory advice, and business transformation services, to help selecting the right RIM platform provider and preparing and organizing the right data, we provide the full range of guidance and implementation expertise to smooth the path to market.

We also help master the complexity between Hardware (Devices), Electrotonic (Sensors) and Software which is typical for smart devices (see Prof., Porter: How smart connected products are transforming competition) especially in the context of validation.

We can advise on and provide tailored services around:

  • Individual regulations in target markets
  • Required system capabilities
  • Data scoping, structuring, migration, and analytics
  • Standard operating procedures
  • Systems validation/quality management

Because we know the Life Sciences industry so well, and what’s needed to foster the right data delivery and data practices, we’ll help you maximize the payback on your product innovation and associated investment. fme can also support the necessary Sales Transformation, as selling Smart Medical Devices is different than selling just Smart Devices.  

Crucially, we are vendor independent which means we’ll provide technology and data recommendations that fit the exact needs of your organization.

To discuss your specific needs with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.

UDI compliance: Achieving end-to-end medical device traceability

UDI compliance: Achieving end-to-end medical device traceability

Compared to the safety measures and compliance hoops faced by pharma companies for human medicinal products and their ingredients, the collection, standardization and monitoring of medical device data has been relatively rudimentary up to now.

But that must change if medical device or combination product manufacturers and their component suppliers are to stay the right side of the authorities. Continuing to track products using spreadsheets is unsustainable, and is preventing a clear line of sight across component sourcing, and device production and distribution. This is both risky to patient safety, and inefficient operationally.

Pharma companies with a medical device portfolio may have focused so heavily on drug-related regulatory information management that they’ve neglected to apply equivalent systematic rigor to handling medical device product data. As new waves of international Unique Device Identification (UDI) mandates hit, and as the respective authorities look to extend the scope to component manufacture, it’s time to rebalance attention and budgets.

UDI: A Global Initiative

Around the world, starting with the most safety-sensitive medical devices, regulators are gradually phasing in a Unique Device Identification (UDI) system. This is designed to provide single, globally harmonized positive identification of medical devices across their distribution and use. The goal is to ensure that any piece of medical ‘equipment’ – whether an implant, wearable device, syringe, or MRI scanner – can be traced back to its source for safety and accountability reasons. Worldwide, requirements across more device Class types are becoming mandatory and manufacturers without UDI risk being refused market access, and may be subject to legal and financial penalties.

UDI Compliance: Traceability is empowering

From the side of the public, a major benefit of UDI is its ability to enable a swift response to quality issues for efficient, targeted, and timely product recalls. From the manufacturer side, systematic device identification and information tracking paves the way for improved inventory management and supply chain efficiency, helping healthcare providers and manufacturers track the movement of devices, minimize errors in distribution, and optimize inventory levels.

The great thing about UDI is that it promotes the standardization of data related to medical devices, making it easier to integrate and exchange information across different healthcare systems and databases. The US FDA categorizes these slightly differently than the EU, and several other regions or countries each have their own guidelines. (Click here for overriding international guidance.) But once manufacturers across the world are all using an agreed system for identifying devices, and indeed for recording and reporting adverse events, it will become easier for healthcare systems to communicate and share associated information across borders.

Technology & Data Decisions

Technologically, there are a number of considerations as Life Sciences companies look to bring their medical device identification and end-to-end regulatory information management (RIM) up to scratch. Generally, this starts with the selection of a suitable RIM platform or system; then it’s about creating the right data fields, and flowing in reliable and robust device information in a compliant, standardized, and readily-exchangeable format.

Strategic decisions include whether to choose a single-vendor software platform. This may make it easier to integrate with manufacturing/SAP systems to ensure data consistency and accuracy, as well as process efficiency, across and between functions as part of companies’ broader digital transformation initiatives. Another option is whether to settle on a best-of-breed RIM solution, which stays within its lane and does pure regulatory information management very well.

Work will be needed to assess where relevant data already exists in spreadsheets and other information silos, the state and format of that data and to prepare it for migration into the new target system. To complete the end-to-end system, manufacturing and shipping processes will need to be adapted to ensure that devices are identified and tracked consistently and systematically across the entire product lifecycle, from component manufacture (e.g. all the parts that go into a pacemaker) to post-market surveillance.

In some cases, manufacturers may decide to cease production of one device, replacing it with another so they can start with a clean sheet. But even then there will be base data from the older-generation device that will need to be migrated into the new system to save completely reinventing the wheel.

fme is your Best Partner for UDI Compliance Initiatives

As Life Science and content lifecycle experts, we can help with all of the above. Our business consultants and technical teams are deeply experienced in Life Sciences data-based system projects and end-to-end services; most of our core data team having been RIM system developers for many years.

Crucially, in addition to this vital industry inside knowledge, we are vendor independent. We provide holistic solutions that focus on your unique needs, ensuring you maximize the ROI of your technology budget. We can perform gap assessments, provide regulatory timeline updates, and advise on the optimal roadmap based on the size and complexity of your current medical device portfolio and the structure of your current associated data. fme’s experienced team guides you from beginning to end with comprehensive data migration planning, expedited execution with our proprietary tools and methodologies, plus validation and ongoing support.

To discuss a particular requirement with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.

Pre-plan Your Regulatory Transformation Projects for 2024

Pre-plan Your Regulatory Transformation Projects for 2024

From building a realistic AI roadmap to making better choices about technology partners and broadening the impact of RIM systems, fme’s consulting approach and specialist data services can help pharma, biotech, and medical devices companies maximize investment into their digital transformation journey – both now and in the future.

It can be hard to effectively prioritize an ambitious digital transformation journey when external requirements and technology-based systems keep evolving. In a Life Sciences Regulatory context, those moveable parameters include changes dictated by compliance with IDMP data standards, or unique device identification (UDI) in the case of medical device manufacturers. Other influences might take the form of company mergers or acquisitions that require system consolidation or data harmonization, taking advantage of the continuous changes in evolving technology, or new opportunities to transform processes linked to the Regulatory functionality.

To successfully prioritize next steps and set realistic budgets that align with business goals, it’s important to consider the overall digitalization and transformation company roadmap.

We suggest reviewing these 3 considerations in particular when firming up plans for 2024.

Your roadmap for AI

Everyone is talking about artificial intelligence (AI) and machine learning (ML) as the technology becomes more advanced and accessible for mainstream day to day use. Certainly, it carries enormous potential to save time and drive new process efficiency, consistency, and repeatability. But there are use cases that lend themselves to AI/ML-based transformation, and others that do not, and it’s important to have a clear understanding of both the opportunities and the potential risks.

For instance, Generative AI (assistants like ChatGPT) could be ideal for drawing up job descriptions, summarizing recent achievements for a report or blog article, and/or improving communication across your organization (e.g. keeping everybody up to speed with the progress of a Regulatory Information Management implementation project). But such tools could incur substantial risk if used to generate patient information leaflets.

fme’s technology and content specialists can help you develop an appropriate strategy for your AI journey. Also, we can help you evaluate the current technology landscape – e.g. Regulatory Information Management (RIM) providers or other content management providers.

Get more out of your RIM system

Investing in a RIM system is a strategic move for organizations, with its significance extending beyond the immediate regulatory function. The true value of RIM platforms emerges when they transcend mere content collation and agency submission management.

The potency and transformative impact of a RIM platform become apparent when it delivers rich and comprehensive knowledge, making it accessible across the entire organization. When Regulatory, Quality, and Safety information is holistically stored and managed, strategic teams gain the ability to construct a nuanced understanding of market trends, identify adverse events, and pinpoint gaps in market coverage.

Elevating visibility beyond individual silos is a game-changer, providing C-level executives with a holistic view of organizational dynamics. This comprehensive perspective empowers executives to make informed decisions swiftly, expediting the process of bringing products to market.

Realizing the broader benefits of a RIM platform necessitates the formulation of a clear yet flexible digitization roadmap. Building on a sound data ‘bedrock’ is critical, establishing the right infrastructure and software platform to support smart, digitized information use and process efficiency. This foundation enables strategic compliance with evolving regulations and creates room for targeted adoption of AI and other technological advancements, ensuring the system’s relevance and value for at least the next five years.

Whether the strategic goal involves improved high-level decision support or leveraging Generative AI for routine, low-risk content creation, trust is paramount. Professionals must have confidence in the validity, quality, currency, completeness, and consistency of the information harnessed from the RIM system to effectively drive organizational goals.

Understand what you need from your RIM system and technology partner

Every RIM and content management solution, and technology partner, has its own features and benefits, and selecting the right fit will depend on the size and complexity of your organization as well as your future business goals.

Consider the following: As a pharma company, you don’t produce all the chemicals and machinery that go into the production of a drug. You select and assemble the best components to produce and deliver your product in the most cost-effective way. It’s the same for your technology solutions and partners. Should you expect a single vendor to provide a complete end-to-end solution that amazingly fits your unique needs when procuring a technology platform? No. It’s far more effective to define your requirements, and find technology and partners with their own capabilities, strengths, and experience that aligns with your needs, and all the vendors to concentrate on delivering a solution that is compliant with all regulatory requirements. Your technology vendor shouldn’t have to provide data assessment and migration services, a unique set of skills that are available from skilled specialists.

It’s critical to evaluate potential new technology and partners and understand what qualities you need in the full scope of the project including initial business process and data analysis, implementation and integration, data migration, and post-implementation support. Many decision-makers are swayed by a vendor that appears to offer a full end-to-end solution and services that seem to be packaged with all the associated services. But if those services are all designed around that company’s own product, how can they be sure they’re getting unbiased advice for a futureproof investment? That is an exceptional level of trust for such a large and business critical investment.

Instead of choosing a platform provider based on the promise of an end-to-end service, strategic companies choose knowledgeable and certified technology partners that are 100% focused on their unique business challenges and vision.

As an independent service provider, fme doesn’t have a vested interest in recommending any particular RIM or content management vendor or platform. fme’s consultative approach, specialist data services, and proven tools are designed to optimize the selection, delivery, and output of the system of choice. With proven strategies, fme helps companies navigate the complex minefield of vendors and technology options. Not only do we clarify and define your unique requirements, we have extensive experience with all the leading RIM platforms, along with deep insights into where these fit best relative to the type and size of the organization and its specific priorities. We help companies select and implement solutions that fit their needs in the short- and long-term, solving today’s challenges, manage and maintain those solutions as they grow, and establish a pathway for continual improvement as technology evolves.


Whatever your digitization objectives, fme’s business, technology, and content experts can help you assess and maximize the ROI of your plans. Whether you are planning a stand-alone project or incorporating an initiative within the context of other ongoing projects, fme can help you align your business strategy, technology, and priorities with your available resources, as well as platform vendors’ respective product roadmaps.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and provide an independent perspective designed to amplify your business success.