Evidence generation teams understandably feel a sense of achievement after building an integrated evidence plan (IEP). And they should—it’s not an easy undertaking. But what comes next is just as important: executing the IEP and translating its strategy into impactful studies and insights.

We believe a structured approach offers the best path to success for IEP execution teams. By establishing strong governance, forming dedicated evidence generation teams and defining clear ways of working, companies can accelerate execution, ensure cross-functional alignment and maximize the impact of their evidence.

Our 2024 integrated evidence benchmarking survey (see the Figure below) revealed teams don’t feel prepared to implement and track IEPs. But it doesn’t have to be this way. These three best practices can help your IEP deliver timely and valuable evidence for key decision-makers.

Establishing a governance structure is key to IEP execution success—and regular IEP execution meetings play a vital role. These gatherings should become a standard practice across your portfolio, with your team convening two to eight times per year based on where the product is in its life cycle. We recommend meeting more often for products in dynamic markets.

Strategy and operations (S&O) or the IEP project managers (PMs) should schedule these meetings weeks and months in advance. Another key role in your governance structure is an assigned, accountable project owner who can make swift decisions and present strategic options to leadership. This person is usually the medical affairs product lead or their collaborator in real-world evidence (RWE) or health economics outcomes research (HEOR). These roles should have the strategic thinking ability, domain expertise and business acumen to rationalize choices and trade-offs across projects and studies.

IEP execution often informs the business planning process or broader governance to gain endorsement and funding for evidence projects. Without the right controls, we have seen significant rework as evidence projects progress, particularly in feasibility analysis, data procurement and protocol writing—only to be squashed by leadership who deems the potential outcomes as risky or incongruent with the asset’s strategic direction. By implementing these governance structures, your organization can enhance accountability, streamline operations and ensure the successful execution of the IEP. 

The team often thins out at this point in the IEP development life cycle. No longer do we see broad cross-functional input and market representation; rather, focused experts deep in real-world data, methodologies and evidence design become more involved. We recommend retaining key players who can represent the choices made upstream—such as prioritized customer needs and gaps—but also drive high-quality evidence projects that will be relevant and compelling to the external audience.

S&O or PMs should remain involved to ensure they can report the plan’s progress in a timely and accurate manner. At this point, scientific communications may begin to play a greater role because maturing evidence projects can directly affect abstract and poster submissions, as well as manuscript authoring.

One core responsibility for evidence generation teams is ensuring studies are executed in a timely manner to meet the critical evidence needs outlined in the IEP. It’s vital they translate these needs into open research questions (ORQs) and design corresponding evidence generation activities, studies and analyses. Additionally, the team must interpret results, assess tactical and strategic implications and verify that study designs and outcomes align with key messages for both internal and external communication strategies. Finally, they need to optimize and advocate for funding to maximize the impact of IEP execution.

Together, this group should set the rotating agenda for those recurring meetings and secure the right inputs before each session. With consistency and efficiency in mind, these meetings should follow a common structure, but the topics discussed can be fluid and reflect the decisions needed or the most pressing issues.

To design high-quality meetings focused on the right business questions, it’s essential to establish a consistent structure while allowing flexibility to address evolving priorities. S&O, PMs and project owners should set rotating agendas and secure key inputs in advance, ensuring each session is purposeful.

Meetings should be timely and focus on making important decisions around topics such as activity designs, ownership assignments, proposals and data readiness for congresses. Regularly scheduled meetings foster alignment, mitigate risks and support agile decision-making. They’re vital to enhancing collaboration, maintaining strategic focus and driving more effective evidence generation outcomes with a structured but adaptable approach.

At the plan development stage, many of the proposed evidence generation activities are high-level concepts. IEP execution creates detailed study concepts, layering in more considerations for feasibility. Teams should first validate that the catalog doesn’t contain existing evidence, while also assessing whether the question has partially or wholly been addressed in the literature. This step is a major barrier for companies who want an easier way to see what scientific constructs academia or research institutions have already established. Real-world data assessments determine the viability of answering ORQs for retrospective analyses.

Larger investments such as prospective RWE studies, new company-sponsored registries or phase 4 studies will be initiated as subworkstreams. These projects will undergo further analysis, due diligence and external expert consultation to ensure they’re worthy of significant investment.

A real-world example: We worked with a pharma company to secure a $40 million investment in a phase 4 clinical trial based on a concept that emerged from the IEP workstream. To justify this investment, we examined labels and claims from other assets in the disease, interviewed U.S. and EU thought leaders and objectively prioritized variables and endpoints that would complement the ongoing registrational program.

Teams should periodically present feasibility analysis outcomes to the group or consider a walkthrough of a final protocol. Increasingly, this is when cross-portfolio synergies are created. Rather than initiating evidence projects that only benefit one asset in the portfolio, teams seek to use one study to address multiple gaps and questions across IEPs. A systematic literature review, for example, might address foundational questions across multiple assets being investigated for the same target disease.

Every study and sub-analysis, including newly prioritized post-hoc data mining, is assigned an operations lead. These individual study owners, typically a PM or someone from S&O, actively coordinate with relevant cross-functional teams to engage the appropriate subject matter experts and secure necessary support. This collaboration is crucial to ensure studies are executed efficiently and align with the evidence generation plan’s timelines and objectives. In addition to designing and running the study, this team also surfaces potential risks—such as data, timeline, strategic misalignment and delays in author engagement­—while working with the IEP execution team on mitigation strategies.

The operations lead is responsible for communicating the agenda for working meetings and scheduling presenters. They also manage calendars and timetables for governance reviews, along with the investigator-sponsored research RFP cycle.

Their other critical role is proactively managing and progressing the plan, which includes looking ahead at evidence projects expected to mature in the next 12-18 months and ensuring timelines don’t shift or are appropriately managed when they do. They can look at plan progression by activity type, but also from the strategic lens of the prioritized evidence gaps. They represent how much overall progress and recent progress has been made toward answering open questions. 

To effectively execute the study and evidence generation plan, study owners and evidence generation teams must meticulously identify and detail necessary resources—these include budget, human resources, technology and external collaborators. This thorough assessment ensures all elements for successful study execution are in place, facilitating a smooth and efficient process aligned with strategic objectives.

Sharing interim results as the plan progresses is a key function of the IEP execution team. They should regularly review preliminary tables, lists, figures and data to confirm that hypotheses are confirmed and the data is aligned to key value messages. It’s critical for this team to absorb and analyze the data, as well as how to reprioritize follow-up analyses and generate the strongest claims possible from the ongoing book of work. They should carefully consider submission deadlines so the company can stack reinforcing and confirmatory evidence into a single meeting.

At the same time, the IEP execution team should keep an eye on new scientific disclosures from their competitors. During one IEP execution program we led, the client’s competitor delivered unexpected patient-reported outcomes at a key congress. While our IEP execution team didn’t have these data, we helped the client develop a small chart audit across three key centers of excellence. By doing so, we were able to respond and show our client’s product had a similarly positive impact. 

Leadership understandably wants to be kept abreast of the report’s progress. The IEP execution team should develop processes to track study completion and assess the plan’s progress toward closing evidence gaps—whether for a specific asset or the entire portfolio. Central reporting, KPIs and analytics should be made available across plan metadata and evidence catalog information, with integrations for publications data.

Tracking also includes evidence pull-through, with the IEP execution team creating organizational awareness of newly communicable evidence. As new publications become associated with evidence projects, they can alert relevant stakeholders and connect the publications back to the source need and customer questions, enabling them to close the loop with external stakeholders.

Best-in-class IEP teams can take this one step further by assessing the marketplace impact of the evidence—they can do this by understanding changes in HCP awareness, knowledge, attitudes, beliefs or behaviors. Automated analysis through the organization’s medical intelligence capability is another method for assessing marketplace impact.

A variety of tools can be employed for the purpose of tracking and reporting, and spreadsheet or presentation tools can be used for data entry and visualization. However, for more efficient and scalable tracking, we recommend digital tools to address these needs and automate tracking and reporting. 

Sharing knowledge across functions enhances the quality of evidence generated and promotes innovation and efficiency. Teams can identify potential challenges earlier and develop proactive solutions to reduce risks and maximize effectiveness. Additionally, by engaging with other asset teams, the organization can align with broader strategic goals.

A maintenance stage is an important final phase of the IEP execution timeline. The IEP execution team should monitor the plan and incorporate the latest insights from market events, competitive intelligence, regulators, market research, advisory boards and medical science liaisons. Optimizing the plan through regular engagement and knowledge-sharing empowers your organization to adapt to changing circumstances, capitalize on emerging opportunities and maintain a competitive edge in evidence generation.

Integrated evidence planning is transforming how companies deliver a complete and differentiated evidence package to the marketplace. However, achieving success requires an effective shift from developing the plan to actually executing it. Mastering IEP execution is a critical competency that requires people, process and technology. When done well, pharma companies can:

• Accelerate IEP execution by taking an organized approach
• Fulfill evidentiary priorities—such as answering customer questions or closing gaps—by ensuring timely and high-quality delivery of evidence, while also avoiding duplicative and unnecessary studies
• Maintain strong cross-functional alignment throughout the year as evidence activities change
• Close customer questions with expediency and support commercialization goals and objectives