Define the evidence purpose
Translate the intended decision into a focused research or evidence question. Review the information already available, the gap to address and the intended use of the findings.
Evidence & research
Design the evidence
around the decision.
Useful evidence starts with a clear purpose. IAE connects the question your organisation needs to answer with the study approach, governance and practical work needed to produce information it can use.
Discuss an evidence plan
Strategy connected to implementation
The decision
Which evidence will change what we do?
A medical affairs team needs to understand outcomes. A research group is shaping a study. A patient organisation sees a question that existing work has missed. Before commissioning collection, the intended use must be clear enough to guide the design.
Every measure creates work for someone: a participant, a family, a site or a data team. More collection can mean more burden without a stronger answer when the question, method and setting do not fit together.
IAE brings regulatory and research judgement to the brief, the feasibility assessment and the governance. Methodological, statistical and clinical expertise is brought into the assignment where required.
Real-world evidence starts with its intended use.
A dataset is a starting point. The first decision is what the evidence needs to answer and for whom. IAE helps connect that intended use with feasible data sources, governance, participant burden and the specialist methods needed.
A focused planning brief can set out the question, candidate sources, feasibility limits, responsibilities and the next work to commission. IAE does not present access-programme data as automatically sufficient for regulatory or reimbursement decisions.
What IAE brings to the work.
A connected assessment, a clear recommendation and support for the work that follows.
Test the design against delivery
Examine data sources, proposed outcomes, patient-reported measures and site demands. Connect scientific purpose with recruitment, participation and the practical setting for collection.
Establish the governance
Clarify the regulatory and ethical questions, approvals, safety interfaces and data responsibilities. Build a commissioning brief that research partners and specialist contributors can deliver against.
Work your team can use.
The exact deliverables are agreed for the assignment. Typical outputs include:
An evidence planning brief
The decision, evidence gap, intended use and a defined scope for specialist design.
A feasibility and governance assessment
The implications for participants, sites, approvals, safety and data handling.
A commissioning and oversight plan
Responsibilities, deliverables, review points and acceptance expectations for delivery partners.
Research decisions often affect access arrangements and programme responsibilities. IAE keeps those connections visible while preserving the distinct purpose and governance of each activity.
Evidence planning does not establish that a medicine is effective or suitable for an individual. Study methods, clinical decisions, approvals and data arrangements require the appropriate responsible parties and specialist input. Explore research and community priorities
A clearer view of the next decision.
Evidence: distinguish the question before commissioning collection
The intended use of the findings should shape the brief before a collection method is chosen.
| Planning question | Descriptive purpose | Comparative purpose |
|---|---|---|
| What are we trying to understand? | The experience or outcomes within a defined setting or population | Differences between clearly specified approaches or groups |
| What must the brief make clear? | Population, setting, measures, sources and intended use | The comparison, relevant groups, measures, sources and intended use |
| What needs specialist review? | Whether the proposed information can answer the descriptive question, with feasible burden and governance | Whether the proposed design and information support the intended comparison, with methodological and statistical input |
| What should the output acknowledge? | Gaps, limitations and the uses the findings can support | Gaps, limitations and the strength of interpretation the design can support |
The distinction changes the work to commission; it does not establish that an available dataset is sufficient. Clinical decisions, study methods, approvals and data arrangements require the appropriate responsible parties and specialist input.
Bring the decision. We will shape the work.
Share the situation, your intended outcome and any timing that matters. You do not need a complete brief to begin.
Discuss an evidence planScope, responsibilities and fees are agreed before work begins.