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End-to-end clinical development platforms include solutions necessary to perform clinical/safety/regulatory activities with unified data layers with in-sync data, preventing it from remaining in siloes.
Their digital touchpoints allow users to access and support core modules to perform clinical startup, conduct and closeout, regulatory, and safety activities. In addition, it includes rules such as modularity, scalability, interoperability, and supporting a unified data integration layer, making it a platform.
How Pharma Views End-to-end Platforms
The potential benefits of the platform include the lower total cost of ownership, fewer data silos, and a rationalized product landscape, reducing the need for integration and custom development. However, pharma executives do not see it as a business case for adoption.
According to surveys, 92% of pharma stakeholders engaged in clinical development, and the buyers of clinical products say that end-to-end clinical development platforms currently do not exist. Among them, only 28% would want an end-to-end platform for their organizations.
Many buyers believe that end-to-end platforms lack modularity, a unified data layer, or interoperability. The reason may be that they haven’t realized the RoI of adopting such a platform.
Challenges With End-to-end Platforms
Clinical trials require a high degree of coordination among parties using many IT systems, SoPs, and processes. Their global scale and a high volume of trials in progress may pose an added challenge for large pharma players.
For example, a well-known large pharma organization logged over 40 systems, 150 SoPs, and 1,000 documents involved in trial execution. These systems and processes have a large user base, partially organized into task-oriented functions, like site monitoring and therapeutic or geographic functions.
Vendors struggle because organizations are still organized in silos. Platform users still contact individual solution providers with issues they need solving, thus diluting the benefits of a unified platform.
Some of the other challenges are:
- Preference for a best-of-breed approach: Buyers prefer established leaders for individual components, and they do not consider a single vendor across the clinical product suite.
- Maturity: Since end-to-end platforms are relatively new, buyers lack conviction about their functionality.
- Risk aversion: Buyers resist the idea of replacing the existing and well-performing systems with a new ones.
- Existing long-term commitments: Some organizations with long-term commitments with their current clinical product vendors deter the adoption of end-to-end systems.
Fostering a process-centered view by implementing a business process management (BPM) approach will optimize the clinical trial process using technology and process.
Defining Business Process Management
Business Process Management (BPM) is about developing a process enterprise. A process enterprise is one in which people have an end-to-end view, where they follow a process according to its design.
Fundamentally, BPM involves proper process documentation, monitoring mechanisms of the process’s health and performance, governance of that process, and driving improvement and operational excellence in line with the organizational strategy.
The organization can entrust a few key individuals to take ownership of end-to-end processes and systems and fashion them into a productive network to drive improvement. Cultivating end-to-end thinking results in people considering what’s happening upstream and downstream from where they are in the process.
A holistic BPM requires a framework and business process maturity model, which involves a process framework, skills, capabilities, systems, technology, strategic process alignment, a culture to deliver value, innovate and continuously improve. You must also measure the performance of the process using specific KPIs and metrics.
Creating an End-to-end Clinical Development Process Framework
Creating an end-to-end clinical development process framework means identifying the major value streams and sub-processes that include their inputs, outputs, and relationships. After establishing the process framework, you can designate people to ‘own’ the process. The responsibilities include:
- Creating and maintaining the design process.
- Ensuring adequate training.
- Assessing process performance.
- Observing and investigating the performances.
- Incorporating new regulatory requirements into the design process.
- Getting modifications to support process systems.
Process owners must draw on other stakeholders like the subject-matter experts, value stream and system owners, sponsors, and quality and regulatory experts. They should derive information with help from the stakeholders to capture and discuss process-specific information.
The value stream owner must review process performance, prioritize improvement opportunities, and act on those opportunities as part of an annual improvement road map or future-state design.
Driving Adoption for End-to-end Platforms
Vendors can take a multi-pronged approach can get buyers to adopt the platforms. Let us go through them:
- Build from the ground up: Instead of taking an existing point solution and connecting them to form an end-to-end platform, building one tailored to a process will enhance interoperability, ease usage, and improve user-centricity.
- Build business cases: Vendors can create case studies and success stories for a platform-led approach, helping influencers build a business case for adoption. They can articulate business benefits, future technology roadmaps, and showcase testimonials and move the conversation on end-to-end platforms.
- Co-innovate: Build relationships by exploring improvements in platform capabilities and user-centricity while striving for interoperability, flexibility, and modularity to help drive adoption.
- Find innovative commercial constructs: As big pharma needs are different from small/mid-sized pharma, consider differentiated commercial constructs to increase reach and accommodate risk-sharing or outcome-based constructs in pricing.
Creating a process enterprise is not an end; rather, the first step to drive organization-wide end-to-end thinking. Employees must understand how their work fits into the bigger picture, given the inherent complexity in clinical organizations, which only process thinking can enable.
Driving change takes time. Since entrepreneurs are change-averse, they’ll need to be convinced to think seriously about adopting a single platform for their clinical development needs.
Pharma needs real-time opportunities for sales teams to take proactive action. Considering the complexity, cost, and risk factors involved in drug development, companies need timely and incisive inputs to enable strategic decisions. Draup can provide actionable and timely insights, ensuring commercial viability and profitability of drug roll-out plans.
