Project Delivery for New eTMF Solution Implementation

Background Information

A Global Pharmaceutical company that had grown through multiple acquisitions found it was managing multiple repositories and Trial Master File (TMF) solutions. Moreover, the company’s primary technology was outdated and in need of a major overhaul to support the current TMF reference model. Generally, inefficiencies abounded for managing the TMF for both the business and information technology functions.

The company set out to implement a cloud-based, state-of-the-art and compliant electronic document management system to effectively and efficiently manage the Trial Master File across R&D to be used throughout the lifecycle of clinical studies.

Key Problems

The current environment posed many challenges and inefficiencies. Often, TMF tracking was done using spreadsheets because the outdated technical solutions in place were not consistent across the enterprise. Although the company managed to maintain compliance with regulatory agencies, the manual processes required to do so were becoming overly burdensome, and the risk of non-compliance grew greater as time passed on.

Further, the systems did not support the modern workforce as it didn’t allow workers access through different devices and from remote locations. Simple reporting was completed via manual, offline processes and tools. Many of the current tools were stand-alone, and there was very little integration in place to support needed end-to-end processes.

Daelight’s Solution

When this Global Pharmaceutical company turned to Daelight, we assigned a seasoned project manager to help drive a future-state solution to advance the needs of the business and help overcome their many challenges.

Working with the client, the Daelight team began to outline the challenges and draft business requirements that were used to drive a vendor selection across the many capable eTMF solution providers. Ultimately, Daelight helped the client determine that the Veeva Vault Clinical – eTMF solution was most aligned with their requirements and objectives.

Once Veeva Vault had been selected, the Daelight team managed this project holistically on the client’s behalf. The Business Analysis team helped the client optimize their business processes around their future state capabilities and was then able to elicit and document all user requirements to define the solution. The team also developed the integration architecture and design to provide a seamless solution across multiple systems. Further, they completed all the data analysis and mapping required to support the new solution.

The project management team oversaw all workstreams and coordinated efforts to ensure the project was delivered within the requirements of the client’s System Development LifeCycle (SDLC). By partnering with the client Validation and Quality representatives, a Health Authority Regulated (HAR) compliant solution was delivered.

This team also partnered with the client to ensure the configuration of the solution, performed by Veeva, met all user, security and technical requirements.

As with any large program involving dozens of stakeholders and hundreds of eventual system users, Change Management is a critical component to ensure the success of the project. Accordingly, the Daelight Team managed project communications and supported the development delivery of all necessary training. Additionally, the team led the efforts to identify, modify and approve all procedural documents such as SOPs, Work Instructions and Job Aids.

In the end, the entire project team delivered an advanced technical solution as well as all of the other surrounding needs required to ensure a successful implementation. Daelight’s team was integral throughout every aspect of the solution delivery.

Results

Daelight’s collaboration on this project brought about a delivery within its scope, on-time and under budget! Our client is now enjoying a state-of-the-art eTMF solution, and the users have overwhelmingly reported very positive feedback. Adoption and user-satisfaction have exceeded all expectations as workers enjoy the freedom that comes with the agility of an advanced, cloud-based solution, enabling them to work how and where they need.

The anticipated efficiency gains are being realized as manual tracking is now a thing of the past. Business processes are streamlined because they now have a cohesive solution to support multiple functions. All of this was achieved in effective collaboration between the Project team, the Business, the Information Technology group, Validation, Quality Assurance and the vendor, Veeva.

Daelight’s client is now evaluating the furtherance of business uses to be leveraged by the addition of this technology. Plus, they are asking Daelight Solutions to help them continue to deliver tangible business results.