Services | Based Evidence · HEOR, RWE, GRADE and HTA

Clinical epidemiology

Clinical epidemiology and study design

This is the discipline everything else rests on. Long before a systematic review or a guideline exists, someone has to frame the question properly, choose a design that can answer it and anticipate the biases waiting to distort it. That is where we work.

We design and analyse full clinical and epidemiological studies: interventional and observational, prognostic, diagnostic accuracy and measurement. We write the analysis plan before we look at the data, the only way a result means what it claims to mean.

This capability also covers real-world evidence studies and pharmacovigilance support: the same methods, applied to routine practice data.

Typical deliverable: protocol, sample size calculation, statistical analysis plan, documented dataset, results report and manuscript.

Protocol designSample size and power Statistical analysis planCohort studies Case-control studiesClinical trials Diagnostic accuracyPrognostic studies Survival analysisConfounding control Instrument validationPatient-reported outcomes Real-world evidenceBurden of disease Treatment patternsComparative effectiveness Pharmacovigilance supportImplementation research

Framing the question and choosing the design
Sample size and statistical power
Protocol and ethics committee submission
Data management and quality
Statistical analysis and confounding control
Interpretation, limitations and publication

HEOR · Evidence synthesis

Evidence synthesis and analysis

We answer clinical and policy questions with reviews another team could reproduce step by step. Registered protocol, documented search, dual screening, risk of bias assessment, and a GRADE certainty rating for every outcome critical to patients.

Typical deliverable: methodological report, GRADE evidence profile (Summary of Findings), database of included studies and a manuscript ready for submission.

Systematic reviewMeta-analysis Network meta-analysisRapid review Overview of reviewsLiving evidence SLR / TLR

PICO formulation and protocol
Reproducible systematic search
Risk of bias (RoB 2, ROBINS-I, AMSTAR-2)
Meta-analysis and sensitivity analysis
GRADE and SoF profiles
PRISMA reporting

GRADE · Clinical practice guidelines

Clinical practice guideline development

We run the whole process: de novo, adoption or adaptation (GRADE-ADOLOPMENT). We build the panel, manage conflicts of interest openly, apply evidence-to-decision frameworks and draft recommendations whose direction and strength are justified in writing.

Typical deliverable: full guideline with graded recommendations, EtD tables, an implementation version and dissemination material.

GRADE de novoADOLOPMENT EtD frameworksPanel facilitation COI managementAGREE II Implementation indicators

Scoping and question prioritisation
Panel composition and facilitation
Declaration and management of conflicts
Evidence to decision (EtD)
Drafting the recommendations
Plan for updating

Qualitative research · Mixed methods

Qualitative research and mixed methods

Numbers tell you what happened; qualitative research tells you why. We study how patients, carers and professionals understand a disease, a treatment or a care pathway, using methods held to the same standard of rigour as a clinical trial: justified purposive sampling, documented saturation, dual coding and an audit trail for the analysis.

It is also where patient values and preferences formally come from, one of the domains GRADE requires before anyone issues a recommendation. Our CEO co-wrote the GRADE method for rating exactly that kind of evidence.

Typical deliverable: protocol, interview or focus group guide, codebook, findings report with verbatim quotes and, where applicable, integration with the quantitative component.

Semi-structured interviewsFocus groups Thematic analysisGrounded theory Values and preferencesPatient experience Mixed methodsBarriers and facilitators

Design and purposive sampling
Ethics committee and consent
Data collection and transcription
Dual-reviewer coding
Saturation and triangulation
COREQ reporting

HTA · Market access

Health technology assessment and access

We translate clinical evidence into value arguments payers and health authorities can assess: relevant comparators, outcomes that matter, explicit assumptions and uncertainty analysis.

Typical deliverable: value dossier, documented economic model, budget impact analysis and technical support throughout the decision process.

Value dossierCost-effectiveness Cost-utilityBudget impact Comparators and outcomesResponse to technical queries

Defining the decision problem
Supporting clinical evidence
Economic modelling
Probabilistic sensitivity analysis
Documenting the assumptions
Technical support through the process

Training

Training and professional development in evidence-based medicine

Programmes designed to leave your team standing on its own, not dependent on us. In person, online or blended, with exercises built on your institution's own documents.

Typical deliverable: curriculum, materials, facilitated workshops and competency assessment before and after.

Critical appraisalApplied GRADE Guideline methodologySystematic searching Applied biostatisticsScientific writing

Needs assessment
Tailored curriculum design
Workshops using your own cases
Mentoring of in-house projects
Pre and post assessment
Certificate of participation

Rare diseases

Few patients means thin evidence, and the usual methods fail. This is exactly the ground where methodological judgement decides whether a decision will hold.

In rare diseases you almost never have a large clinical trial, a clean comparator or well-established outcomes. Follow the standard handbook and you get a very low certainty conclusion and a paralysed committee. The skill lies in knowing what imperfect evidence will support, and putting the uncertainty on record rather than burying it.

We work with case series, patient registries, natural history of disease, real-world evidence and formal expert consensus. Qualitative research brings in the perspective of patients and carers; under these conditions it stops being a complement and becomes a primary source.

The same work, organised by who decides

Pharmaceutical and medical device industry

Usually the goal is to prove value to a payer, or close an evidence gap the pivotal trial does not cover.

Systematic reviews for regulatory and medical affairs
Post-marketing real-world evidence studies
Value dossiers and budget impact analyses
Formal expert consensus and methodological advisory boards

Governments, ministries and multilateral agencies

Here the goal is a recommendation or a policy that stands up publicly and can be audited.

National clinical practice guidelines with GRADE
Evidence synthesis for public policy
Prioritisation of technologies and interventions
Building in-house methodological capacity

Insurers, health plans and healthcare providers

The goal is deciding what gets covered and on what criteria, and cutting unwarranted clinical variation.

Health technology assessment for coverage decisions
Institutional protocols and care pathways
Analysis of variability and outcomes
Evidence committees: design and support

Scientific societies, universities and research groups

The goal is methodological rigour and publication, with support from people who know the standard from the inside.

Methodological leadership of society guidelines
Methodological co-authorship of reviews and studies
Training programmes for residents and faculty
Mentoring in scientific writing and submission

What clients ask before hiring us

What is GRADE and why does it matter for my decision?

GRADE is the international system for rating certainty of evidence and strength of recommendations. The World Health Organization, Cochrane and more than a hundred organisations use it. It matters because it separates two things people routinely confuse: how confident we are about the effect, and how strong the resulting recommendation should be. That separation is what makes a decision defensible. More on our GRADE practice.

How long does a systematic review take?

It depends on how much literature there is and how wide the scope runs. A well-conducted rapid review takes 6 to 10 weeks; a systematic review with meta-analysis usually takes 4 to 6 months. On the first call we give you the real range for your question, not a generic number.

Do you work with our institution's data or bring your own?

Either. We can work with your own databases under a data processing agreement, or design primary data collection from scratch. In Colombia we operate under Colombian Law 1581 of 2012 on data protection, and every protocol that needs ethics approval goes to a committee.

Do you use artificial intelligence in the process?

Yes, wherever the output can be checked: assisted screening, data extraction with human validation and continuous literature surveillance. We do not use it for certainty judgements, clinical interpretation or drafting recommendations. Our full position.

How do you handle conflicts of interest when the client is industry?

By separating the roles explicitly. The funder sets the question and supplies information, but plays no part in the methodological judgement or the conclusion. We document every declaration of interests and publish it alongside the output. If a project needs a conclusion decided in advance, we turn it down.

Do you take on projects outside Colombia?

Yes. Our CEO is a methodologist for the World Health Organization iCAM guideline in Geneva, and served on its Guideline Review Committee from 2022 to 2026. We have contributed the guideline methodology for ARIA-EAACI, the American Society of Hematology and the World Allergy Organization, and adapted guidelines to the Saudi context. We work in Spanish and English.

How we can work with you