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
Real-world evidence consulting.
Start with the decision.
Useful evidence starts with a clear purpose. IAE provides real-world evidence consulting and integrated evidence planning, connecting the decision your organisation needs to make with feasible data sources, study approach and governance. Methodological, statistical and clinical input is agreed where the assignment needs it.
Discuss your access and evidence model
Strategy connected to implementation
The decision
Build evidence into the programme from the outset.
Start with the decision the evidence needs to support. IAE helps sponsors turn an outcomes question into a practical real-world data (RWD) and real-world evidence (RWE) plan, connecting data sources, patient-reported measures, study governance and technology selection. An access record alone does not establish reliable RWE.
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.
For medical affairs teams building an integrated evidence plan, this means agreeing the decisions and evidence gaps before listing studies or data sources.
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.
Match collection to the question
Assess existing data, outcome definitions, missing data, bias and site or participant burden. Consider electronic data capture (EDC), registries and electronic patient-reported outcomes (ePRO) only where they fit the design and intended use.
Establish the governance
Define consent or another applicable basis, ethics and regulatory review, safety interfaces and analysis responsibilities with the appropriate specialists. Decisions about treatment access must not depend on participation in optional research.
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 collection and technology assessment
Data sources and measures, EDC or registry requirements, ePRO suitability, participant burden and a proportionate supplier comparison.
A commissioning and oversight plan
Delegated work, data management and analysis responsibilities, access rights, review points, acceptance criteria and archive or exit arrangements.
Choose only the technology the study needs
Compare retaining a suitable sponsor-owned system with adding a commercial platform, a supported open-source EDC or specialist research services. A low software licence price is only one cost: include study build, qualification and validation, hosting, support, data management, instrument licences, languages, interfaces, changes and archive or exit.
An access portal can support requests, approvals and operational status. An EDC or registry supports protocol-defined clinical data; ePRO captures agreed patient-reported measures. Safety reporting has its own responsibilities and systems. These functions need defined interfaces and reconciliation; one does not automatically replace another.
Keep systems and records under sponsor oversight
Plan around sponsor-owned systems and designated repositories, including SharePoint where appropriate for controlled documents and oversight. A document repository is not automatically a validated EDC, safety database or unrestricted patient-record store.
Controlled exports and status exchange may be sufficient. Consider an API connection only where the benefit justifies mapping, testing, validation and maintenance. Define minimum necessary identifiers, access controls, source ownership, audit history, reconciliation, failure handling and data export rights.
IAE can assess requirements and coordinate a defined specialist contribution. An interface or provider relationship remains a proposal until its scope, qualification, contractual arrangements and operating evidence are established; this offering does not claim an installed integration or a full-service CRO.
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 your access and evidence modelScope, responsibilities and fees are agreed before work begins.