Veeva Systems

Bayer, a large biopharma company based in Leverkusen, Germany, was seeking to enhance its customer engagement strategy for healthcare professionals (HCPs), patients, and caregivers. The company aimed to deliver personalized messages at the right time and place, but this required a shift from channel-specific thinking to a more connected approach across in-person and digital channels. The challenge was to integrate digital experiences with face-to-face communication and sales consultant activities, as well as patient and caregiver communication. Bayer also needed to establish foundational technology and optimize messaging across channels. Another challenge was to connect digital marketing and field force activities, which required understanding customer needs and leveraging data to tailor communication.

Pfizer, a leading biopharma enterprise, was facing challenges in managing its content supply chain. The company was grappling with the need to provide more fluid and personalized content to its customers. The operations team was tasked with overseeing the creation, approval, and dissemination of marketing and medical content. They also had to manage the data ecosystem, which included capturing and managing information and stewarding healthcare professional interaction data. The shift from multichannel to omnichannel communication was a key priority, but it presented significant challenges. Integrating channels that had been operating independently was a daunting task, and the company had to either spend time stitching them together or start afresh. Additionally, the company had to bring new capabilities, like metadata, to the fore to inform data-driven decisions.

Merck KGaA, a large biopharma company based in Darmstadt, Germany, was facing challenges in the evolution of the brand manager role. The traditional methods of brand management were no longer sufficient in the digital age. The company recognized the need for brand managers to delve deeper into customer data and understand the story it tells, rather than relying on quantity measurements like clicks. However, there was a gap in the skills and expertise required to perform this analysis. Additionally, the company was grappling with the need to operate in both digital and traditional environments, and the pace of brand marketing was increasing rapidly. The challenge was to upskill brand managers or bring in new skills, and to manage digital assets effectively to create and communicate quality content at a faster pace.

UCB, a biotech company based in Brussels, Belgium, was facing challenges in its Medical Affairs department. The department was in the process of transforming to become a more strategic partner alongside the traditional pillars of R&D and Commercial. However, patient fragmentation, stakeholder diversification, and digital disruption were creating an added sense of urgency for medical to take on its new role. The head of global medical affairs at UCB, Catrinel Galateanu, identified the need for the department to become a strategic, active leader at the center of R&D and commercialization efforts. The department was also tasked with articulating the value of the science and solutions to patients and diverse stakeholders. To achieve this vision, the department needed to focus on mastering insights to further strategy development, servicing a diverse universe of healthcare stakeholders, and prioritizing impact and new skills.

Bristol Myers Squibb, a large biopharma company, was facing challenges in establishing an effective omnichannel content strategy. The term 'omnichannel' was widely used within the organization, but its meaning varied among different stakeholders, leading to confusion and misalignment in strategy. The company also struggled with gaining buy-in and advocacy from the leadership team for the omnichannel approach. The leadership team needed to understand the potential impact of an omnichannel strategy on the organization and how it could benefit their customers. Additionally, the company was grappling with the challenge of not overwhelming their customers with too many channels, but rather focusing on the right ones.

GSK, a global healthcare company, was facing challenges in managing its clinical data due to the use of multiple Electronic Data Capture (EDC) systems and complex processes. The company was using at least four different types of EDCs within its clinical data ecosystem, each customized to such an extent that it resembled a jigsaw puzzle. This complexity was slowing down the process of data review and management. Additionally, the company was struggling with the proliferation of digital data sources as it embraced hybrid digital trial models. The need for effective data management had become a key driver of trial success. GSK also aimed to accelerate the delivery of life-saving treatments, a goal hindered by the existing complex data management system.

Novo Nordisk, a large biopharma company based in Denmark, was grappling with an enormous and rapidly growing volume of content. The company needed to establish new ways of working to manage this content effectively and achieve its business goals. The challenge was not only to secure executive-level buy-in for initiating transformational change but also to ensure bottom-up commitment for early adoption and execution. The company also faced the challenge of managing expectations, particularly in terms of timelines for game-changing innovations. Additionally, Novo Nordisk had to navigate the mindset shift across stakeholders, especially with agencies, and manage the transition to new ways of working.

Illumina, a leading biotechnology company, was facing significant challenges in managing their study builds. The traditional process involved authoring and reviewing specifications for over three months, after which the Contract Research Organization (CRO) would build the database. This process was not only time-consuming but also lacked efficiency and agility. The study team would then review the specifications, which was a manual, paper-based process. Additionally, Illumina was conducting 100% regression testing during User Acceptance Testing (UAT), which was a significant burden. The company was also running a COVID-19 diagnostics trial during the pandemic, which required great flexibility and rapid changes.

Pacira, a pharmaceutical company, was facing challenges in streamlining its promotional material submissions process. The company was using inefficient paper- and email-based approaches that were not only time-consuming but also lacked the necessary speed and efficiency. The situation was further exacerbated during the pandemic when remote workers did not have access to high-speed printers. Additionally, as Pacira's regulatory department grew, they needed to replace SharePoint with a secure, part 11 compliant system for collaborative authoring and submissions. The company was also looking for a solution that could manage promotional submissions together with their other regulatory submissions on the same platform.

Roche, a large biopharma company based in Basel, Switzerland, was faced with the challenge of balancing a global content strategy with local needs. The company recognized the need for a global-to-local strategy for several reasons. Firstly, the company wanted to reuse content to limit duplication of effort and cost. Secondly, the global-to-local approach was deemed essential for setting up a modular content model. Thirdly, the strategy would help deliver a framework for personalized content and a consistent brand experience. The company wanted to ensure that patients and customers have the same brand experience regardless of their location. Lastly, operational efficiency was a priority, and the global-to-local blueprint was seen as a way to manage and drive change more easily internally than with external business partners.

EQRx, a biotech company based in Cambridge, Massachusetts, was launched in 2020 with the ambitious mission of making innovative medicines available at significantly lower prices. To achieve this, the company needed to build a modern development platform that could align cross-functional business processes and deliver efficiency at scale. The platform needed to meet the company's requirements for minimal custom development, sustainable total cost of ownership, and productized integrations to reduce maintenance and complexity. The challenge was to implement this platform across various departments including clinical data, clinical operations, quality, regulatory, and safety in a short span of time.

GSK’s field teams heavily relied on Veeva CRM for their daily operations. However, they faced challenges in pre-call planning, affiliations management, and direct-to-practitioner (DTP) sampling process. The pre-call planning process was time-consuming as reps had to sift through a lot of unnecessary information to prepare for a call. The process of creating or breaking an affiliation between a healthcare professional (HCP) and a healthcare organization (HCO) was also cumbersome, involving multiple steps. Moreover, with the transition to a fully DTP sampling process, reps had difficulty tracking their inventory of virtual samples. They could only see the sample limits when they were in front of an HCP, which was not efficient.

Kyowa Kirin, a large biopharma company based in Tokyo, Japan, was faced with the challenge of adapting to the digital shift in the industry, particularly in the wake of the COVID-19 pandemic. The company needed to deliver relevant content to healthcare professionals (HCPs) through digital channels, which had become the new standard for interaction in the field. The shift to digital engagement models required the company to create more content faster, while maintaining compliance and cost-effectiveness. The company also needed to harness data-driven insights to inform the content creation process and deliver personalized content at each stage of the customer journey.

Blue Earth Diagnostics, a UK-based leader in the development and commercialization of novel PET radiopharmaceuticals, faced a significant challenge in expanding its U.S. presence and overall reach. Despite having a U.S. headquarters since 2016, the company had not yet established a strong local marketing presence. The marketing team identified social media as the most expedient and effective way to reach a broader U.S. audience. However, building a social media strategy from scratch presented two major challenges. Firstly, the company had limited time and resources to dedicate to social media. Secondly, they needed to create a compliant process for posting and sharing content that would meet rigorous medical, legal, and regulatory (MLR) requirements, a critical factor in the life sciences industry.

The Crofoot Clinic and Research Center, a pioneer in HIV/AIDS research, was grappling with the challenge of outdated, paper-based processes for clinical research documentation. Despite the widespread adoption of digital healthcare technologies, the clinic's research documentation remained largely paper-based, making it difficult for investigators and support staff to manage and access necessary documents. The paper-based system also posed significant challenges for patients participating in clinical trials, who often had to take time off work to review and sign consent forms at the clinic. The complexity of managing patient consent forms, coupled with the logistical challenges of a sprawling metropolitan area like Houston, made it difficult for potential study candidates to consider participating in a clinical trial. The lack of integration between the clinic's data management systems and the various eConsent forms used by sponsors further complicated the situation, increasing work and compliance risks.

Exact Sciences, a molecular diagnostics company, was grappling with an inefficient medical, legal, and regulatory (MLR) review process. The company was using different technologies for MLR review across its various business units, with no enterprise solution or integrations in place. This lack of uniformity and integration was causing inefficiencies and slowing down the review and approval process. The company also lacked dedicated roles for managing the MLR review process, with senior vice presidents often taking on the task. The challenge was to streamline and optimize the MLR review process, implement a scalable technology solution, and change the company culture around MLR.

Emerging biotech companies face significant challenges around document control and inspection readiness. One of the most critical issues is building and maintaining an electronic trial master file (eTMF) that is complete and accurate. Without this, companies are likely to experience delays in market approvals. It is common to see issues with FDA submissions, with 50% ending up with critical data conformance issues. Common quality findings of the Medicines & Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) include data being incomplete, inconsistent, inaccurate, duplicated, misnamed, or misfiled. Furthermore, the shift towards a new digital model for document control presents a steep learning curve for most companies. They need to understand the full capabilities of the technology and either hire new staff to implement it or re-assign existing staff.

Merck, a leading pharmaceutical company, was facing challenges with its traditional content creation process. The company was creating individual content assets from scratch, a method that was becoming increasingly unsustainable due to the changing dynamics of the industry. The process was not only time-consuming but also lacked efficiency and consistency. The company was also struggling with the high costs associated with creating new content for each campaign, especially for email campaigns. The need for a more sustainable, efficient, and cost-effective content creation process was evident.