Which consultancy works on COA and PRO strategy for pharma?

id est point supports COA and PRO work end to end: measurement strategy and gap analysis against regulatory and payer expectations, concept elicitation and content validity, psychometric evaluation, meaningful-change thresholds, exit interviews, COA evidence dossiers for FDA and EMA, and the abstracts and posters that follow. Recent work includes a ten-year analysis of COA label claims in autoimmune disease and a PRO validation programme presented at five neurology congresses.

Do you run real-world evidence (RWE) and patient-level data studies?

Yes. We design extraction frameworks and data dictionaries, extract and code patient-level variables from clinical records, registries and committee documentation with dual-pass verification, and deliver descriptive and comparative analyses with a reusable dataset. All work runs under a data-processing agreement and our data-security SOP.

What HEOR and market access services do you offer?

Global value dossiers, HTA submissions and country adaptations, cost-effectiveness, cost-consequence and budget-impact models, network meta-analysis and indirect treatment comparisons, systematic and targeted literature reviews, value communication, interactive economic tools for affiliates, and HEOR workshops for commercial teams.

What does id est point do?

id est point is a market access and health economics and outcomes research (HEOR) consultancy for pharmaceutical, biotech and medical device companies. We build global value dossiers, HTA and cost-effectiveness submissions, budget-impact models, outcomes research and real-world data studies, and interactive digital tools that carry the evidence into local markets.

Which regions do you cover?

We have submitted, adapted or analysed HTA evidence in Latin America, the Middle East and North Africa, Asia-Pacific, Europe and North America, with particular depth in emerging markets and private-payer systems.

How are engagements staffed?

Each team is compiled for the expertise the question needs, drawing on a standing group of half a dozen specialists in HEOR, health-economic modelling, outcomes research, data engineering and software. One senior lead is accountable from brief to sign-off.

Do you offer embedded or long-term support?

Yes. Alongside project work we place a consultant full time inside a client team for the length of a launch or programme, on annual work orders whose scope is reset as the work evolves and with payment terms shaped around the client's planning and budgeting cycle. The longest such engagement to date ran four consecutive years with a regional market access team rolling out two cell therapies across twenty developed markets.

How quickly can you run payer or expert research?

Through our expert-network partnership we typically identify the right payers, HTA assessors or clinicians within 48 hours, complete recruitment within days and deliver a mixed-method study in about two weeks.

How do you handle confidential client data?

Client data is processed only for the engagement it was shared for and never used to train shared or third-party AI models. We work under documented SOPs for quality management, QC review, data security and incident management, with GDPR-aligned data-processing agreements, encryption in transit and at rest, least-privilege access and agreed retention.

Can you provide client references?

Yes. Client names are withheld on this site for confidentiality; references from global healthcare companies and immunology biotechs are available on request.

id est point | HEOR, Market Access, COA & RWE consultancy

Outcomes research

Optimizing Clinical Outcome Strategies for Regulatory Approvals in Autoimmune Diseases: A Decade of Insights

Client: global immunology biotech, HEOR team
Scope: ten years of FDA and EMA approvals · NICE, HAS and G-BA opinions over the most recent five

Regulatory label review · COA and PRO classification · HTA opinion analysis · Endpoint database

10 years of approvals
2 regulators, 3 HTA bodies
4 COA types classified
1 reusable endpoint database

Evidence strategy

Reading a Phase III protocol the way an HTA assessor will

Client: global immunology biotech, late-stage asset in a rare autoimmune disease
Scope: protocol gap analysis and comparator review ahead of HTA

ITC feasibility · Protocol gap analysis · Comparator landscape · HTA anticipation

3 pipeline comparators
9 studies reviewed (5 Phase II, 4 Phase III)
2 endpoints flagged as HTA focal points
1 comparator judged ITC-feasible

Digital tools

Turning an influenza vaccination cost model into a tool affiliates use every week

Client: global health-economics function of a top-ten healthcare company
Scope: interactive vaccine economic models · hosting, maintenance, country rollout

Model digitisation · Web application · Country adaptation · Publication

2 interactive tools
5 country adaptations
12–16 weeks from kick-off to release
Hosted on the client's own infrastructure

Real-world data

Where the trial was losing patients, and why

Client: global immunology biotech, clinical development
Scope: adjudication-committee records from a Phase III trial

Structured extraction · Patient-level dataset · Descriptive analysis · Documentation gap assessment

70+ variables per patient across 7 domains
Dual-pass verification of every value
Every rejected case traced to its documentation gaps
1 reusable patient-level dataset

Challenge: In a Phase III trial, an independent adjudication committee had to confirm each participant's diagnosis before enrolment, and a large share of screened patients were turned away. Every rejection meant recruitment time and site effort lost, and the sponsor could not tell whether patients were being excluded because they did not have the disease or because their files did not prove it. An initial review pointed to incomplete documentation of clinical features, treatment response and supportive testing; the client commissioned a systematic analysis to confirm the drivers and act on them.
What we did: Designed a structured extraction framework and data dictionary covering the evidence a diagnostic committee weighs: laboratory and antibody test history (including assay type and result), genetic and electrophysiological testing (including whether raw outputs were provided rather than summary statements), documented response to standard and advanced therapies, core clinical features, relevant treatment exposures and family history. Extracted and coded more than 70 variables per patient with dual-pass verification and a query log for ambiguous cases. Analysed documentation availability stratified by committee outcome and by concordant versus tie-break review, quantified the deficiencies most associated with rejection, and synthesised recurring documentation failure modes into a final presentation for the clinical team.
Different: A clinical-trial question answered with real-world-data methods: a reusable patient-level dataset rather than a one-off read-through, built under a signed data-processing agreement and our data-security SOP, with every value traceable to its source page.
Outcome: The sponsor now knows which missing documentation elements drive screen failure and can fix them at source: clearer site guidance on what to submit, targeted support for sites with the weakest files, and adjudication criteria and protocol wording informed by evidence rather than anecdote. Fewer avoidable rejections means faster recruitment and lower cost per enrolled patient, and the patient-level dataset remains available for further analyses and publications.

Payer & expert insight

Fifteen payers and HTA assessors, interviewed and reported in ten working days

Client: commercial-stage pharmaceutical company preparing a high-cost specialty launch in Europe
Scope: mixed-method payer and HTA research · EU5

Payer research · HTA assessor interviews · Mixed methods · On-demand expert network

15 payers, HTA assessors and patient-advocacy leaders
48 h to identify experts
4 days to complete recruitment
1.5 weeks brief to final report

Embedded support

Four years inside a cell and gene therapy launch

Client: global cell and gene therapy company, regional market access team
Scope: full-time embedded support across 20 developed markets, 2 products, 5 indications, 4 consecutive years

Embedded market access · HTA launch planning · HTA objection handling · Knowledge repository · Launch tracking · Affiliate training

4 consecutive years of full-time support
20 developed markets, 2 products, 5 indications
1 searchable HTA question-and-answer repository, maintained monthly
1 launch-tracking tool with monthly reporting to regional leadership

Challenge: Two cell therapies were launching across more than twenty markets, with indications arriving one after another and every HTA body asking its own questions. The regional market access team needed one place where launch timelines, submission requirements and the answers already given to assessors could be found, and it needed senior capacity that stayed for the whole rollout rather than a project that ended at hand-over.
What we did: One consultant worked as a full-time member of the regional team for four consecutive years. The first job was a detailed plan of every market's HTA timeline and submission requirements, turned into a launch-tracking tool that gave an individual and cumulative view of country activities and was reported to leadership monthly. Alongside it we built and maintained a categorised, searchable repository of HTA questions and responses from all markets, so an objection raised in one country could be answered with evidence already accepted in another. From there the work followed the launch: drafting answers to HTA bodies, selecting and adapting evidence for local submissions and checking consistency between them, writing value communication including a full submission dossier and an objection handler, supporting outcomes-based pricing agreements in several markets, and training affiliates on the tools.
Different: Embedded does not mean seconded. The consultant was accountable the way an employee is, picking up what fell between workstreams instead of pointing at a scope line. The contracts reflected that: annual work orders rather than a fixed project, with scope reset each year as the launch moved from first approvals to a steady state, and payment tied to milestones the client chose. That is how we prefer to work on long engagements. Structure and payment terms can be shaped around the client's planning and budgeting cycle, and the commitment goes beyond the letter of the scope, as it would for anyone else on the team.
Outcome: Continuity across a four-year rollout that otherwise turned over staff and agencies; a repository and tracking tool that cut repeat requests to shared-services teams and became the team's working memory; and a model for embedded support we now offer to other launch teams.

Evidence that gets to the point.

Who we are

From insight to access, one partner

Understand the payer

Build the case

Make it land

Carry it into every market

What we do: HEOR, market access, COA and RWE

Global pricing & market access strategy

Local access & HTA

Health economics & statistics

Evidence strategy & synthesis

COA, PRO & real-world evidence

Digital tools & enablement

Selected work