2021 Veeva Heroes Enable Better, More Patient-Focused Drug Development

At a time when many companies still handle clinical data manually and on paper, Tanya has been a staunch advocate for innovation and improved data management. Her message to pharma companies is consistent: Plan strategically and based on your unique needs. It is reinforced in webinars, columns advising emerging biotech companies, and in presentations delivered through the Society for Clinical Data Management. Tanya is also an expert in system validation strategy, and advises others within the industry on best practices.

Tanya was an early proponent of clinical data management systems (CDMS). At Bioforum, her focus on risk-based quality management has brought significant improvements to the way the company and its clients manage clinical data. Under Tanya's leadership, Bioforum became one of the first CROs in the industry to use modern electronic data capture (EDC) approaches, replacing outdated EDC technology that had required custom programming and extensive effort to support. After Tanya and her team rolled out Veeva Vault EDC in 2020, Bioforum increased the speed of clinical trial builds by 35% and of amendments by 70%.

Bioforum CEO Amir Malka spoke for many at the company when he said, 'Tanya pushes us all to challenge the status quo and to be open to doing things in new and different ways for the benefit of the patients we serve.'

Francoise recognized that siloed and manual approaches to managing regulatory data need to change. This is especially true as global regulatory agencies raise their expectations for data governance and the digitizing and standardization of pharmaceutical data. Her commitment to streamlining regulatory data management led to increased efficiency across GxP functions at Pierre Fabre. These improvements will prepare the company to meet evolving standards such as the International Organization for Standardization's Identification of Medicinal Products (IDMP), which aims to improve pharmacovigilance, compliance, and transparency within the industry.

Françoise articulated a clear data management vision for regulatory affairs and governance, convincing colleagues and senior managers alike of the need for more modern, streamlined approaches. She was a leader in the company's implementation of Veeva Vault RIM, which replaced manual processes based on outdated technology.

According to Nathalie Thomas Pujol, the company's head of regulatory affairs, 'Françoise understood the value of the transformation and could explain why it was necessary. She was more than a key contributor to the success of the RIM project; she enthusiastically supported the application's adoption by future users.'

At many pharma companies today, clinical operations are constrained by manual and paper-based processes, which distract clinicians from science and analysis, and increase the risk of noncompliance. At GSK, Astrid saw a need to improve the way that clinical data and operations were managed. She advocated a streamlined approach that would enable proactive compliance and convinced management of the need to change established practices. A crucial part of her vision was moving to a modern electronic Trial Master File (eTMF) solution. Under her leadership, GSK's vaccines division rolled out Veeva Vault eTMF.

Astrid believed that this modern approach to clinical operations documentation could also benefit GSK's pharma division and convinced managers that it would work. Eventually, GSK's pharma and consumer healthcare divisions also adopted Veeva Vault eTMF.

Astrid and her team's efforts harmonized clinical documentation and work processes for GSK's vaccine, pharma, and consumer healthcare divisions, laying the foundation for stronger collaboration in the future. Colleagues have praised this project as one of the company's smoothest technology implementations to date. 'Astrid led an ambitious global rollout for three separate business units. She aligned the teams around a shared vision and proactively anticipated challenges through careful planning and decisive leadership,' said Simon J. Trowell, GSK's vice president of quality, capability, and risk management.

Regulatory agencies often cite pharma companies for inadequate CAPA and quality documentation. In many cases, these issues can be traced to the way that quality data is kept, exchanged, and stored. Moving to streamlined processes and improved quality management systems (QMS) can ease compliance by automating data access and other functions-something Victoria recognized early on.

Victoria saw an opportunity to improve AstraZeneca's overall quality and compliance efforts by strengthening its management of audits, inspections, quality issues, and CAPA programs. She and her team evaluated different QMS platforms and selected Veeva Vault QMS, rolling out the application within eight months. As a result, AstraZeneca has already improved its oversight of quality events and CAPA completion rates with improved escalation and reporting, speeding clinical study protocol processes for 40,000 users throughout the company.

Colleagues have been enthusiastic about the new application. 'It provides a step change in our ability to provide assurance and to partner proactively with stakeholders to share data-driven insights, advice, and expertise,' commented Graeme Downes, senior director of clinical and pharmacovigilance quality assurance. He also praised Victoria for her 'dynamic leadership and innovative thinking.'

Many companies still struggle with the silos that separate functions-and people-within R&D. Michael realized that fragmented applications and outdated systems would not sustain Novo Nordisk's growth and the company's ambitious plans to automate more drug development functions.

Michael's quest for better data connectivity between key functional areas in drug development led him to Veeva Development Cloud, which he and his team implemented across the company's clinical, quality, and regulatory functions. During this process, Michael also developed a novel approach to improve data governance across the new applications.

'Michael is highly respected within IT and the business for his ability to drive progress on key programs,' said Ulla Outtrup, corporate vice president. One of many positive results of Michael's work was the establishment of a global platform team at Novo Nordisk, dedicated to ensuring consistency in the way that the company works with all R&D data applications.