Hero RWE - Receta Cannabis

RWE Services in Medicinal Cannabis

Real-world clinical data transformed into scientific evidence

We deliver specialized services aimed at transforming routine clinical practice into structured, analyzable, and potentially publishable scientific data. Bridging the gap between patient care and clinical evidence.

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Methodology & Integrated System

Electronic platform for
RWE clinical studies

Our end-to-end service encompasses methodological study design, electronic tools for structured Real-World Data (RWD) capture, standardized patient follow-up, and advanced biostatistical analysis.

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Real-World Data (RWD)

From clinical care to real-world evidence

An RWE study evaluates what happens to patients under routine clinical practice conditions. Our proprietary systems capture and structure key clinical variables:

Clinical Profile & Diagnosis

We structure baseline patient data to ensure precise study cohort segmentation:

Diagnosis and past medical history
Specific indication for medicinal Cannabis

Treatment & Dosing Regimens

Comprehensive monitoring of cannabinoid therapy in real-world settings:

Prescribed therapy and standardized formulations
Exact THC and CBD concentrations
Dosage adjustments and titration throughout follow-up

Safety & Pharmacovigilance

Rigorous tracking of clinical safety and potential therapeutic interactions:

Adverse events and tolerability profiles
Concomitant medications and interactions
Changes in baseline therapies and treatment adherence

Reported Outcomes (ePROs)

Outcomes reported directly by patients regarding the daily impact of treatment:

Symptom severity and functional status
Health-related quality of life and perceived improvement
Overall patient satisfaction with treatment

Scientific Methodology

Electronic platform for RWE clinical studies

A core component of our service is deploying validated electronic tools to manage clinical studies and facilitate structured data collection. Receta Cannabis provides a specialized research framework enabling observational studies and evidence-generation projects directly within routine clinical practice.

eICF

Electronic Informed Consent Form

The eICF corresponds to the participant's electronic informed consent. It digitizes the process through which patients receive study information, understand its objectives and procedures, and record their voluntary decision to participate.

eCRF

Electronic Case Report Form

The eCRF is the electronic form utilized by the clinical research team to capture protocol-defined data in a standardized manner. It transforms information gathered during routine care into a purpose-built, regulatory-grade database.

ePROs

Electronic Patient-Reported Outcomes

ePROs allow participants to complete validated questionnaires and standardized rating scales electronically. This systematically integrates the patient perspective into the study, enabling precise tracking of outcomes over time.

An integrated clinical research ecosystem

Participant

eICF

eCRF

ePROs

Database

Real-World Evidence

Research Workflow

From protocol design to scientific publication

Phase 1

Methodology

Research protocol design

Every RWE project begins with a clearly defined clinical research question, from which a rigorous and compliant study protocol is developed.

Primary and secondary clinical endpoints
Inclusion and exclusion criteria
Ethical committee compliance and GDPR data protection
Validated assessment instruments and visit schedule

Phase 2

Development

Data capture & structuring (RWD)

The structured protocol ensures that clinical information collected during routine practice is gathered in a standardized, high-quality manner.

Electronic Informed Consent Form (eICF)
Electronic Case Report Forms (eCRF)
Patient-Reported Outcome measures (ePROs)
Real-world clinical patient monitoring

Phase 3

Analysis

Biostatistical analysis of outcomes

Once the data capture phase concludes, the dataset undergoes analysis strictly according to the Statistical Analysis Plan (SAP) to yield robust evidence.

Symptom progression and health-related quality of life
Adverse event incidence and safety profile
Dosage titration trends and concomitant medication use
Identification of real-world patient population patterns

Phase 4

Dissemination

Generation of scientific publications

Clinical data achieves its full therapeutic value when findings are communicated transparently and submitted for formal peer review.

Manuscript drafting for peer-reviewed indexed journals
Abstracts and oral presentations for medical congresses
Comprehensive clinical study reports (CSR)
Scientific posters and medical dissemination assets

Applied Research

Why generate RWE?

Real-World Evidence research enables the evaluation of critical clinical aspects that are often difficult to fully capture through traditional randomized clinical trials, addressing pivotal questions in routine practice:

How do patients actually adhere to and utilize their treatment?
How do symptoms evolve over extended months of follow-up?
What dosage titrations and modifications occur in routine clinical practice?
How does health-related quality of life change over time?
What is overall patient satisfaction regarding the treatment?
Which adverse events emerge throughout real-world monitoring?
Are concomitant medications reduced, adjusted, or discontinued?
Are there distinct clinical differences across patient subgroups?

RWD captures what happens. / RWE enables its rigorous analysis. / Clinical research translates it into evidence.

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RWE studies do not replace randomized controlled trials (RCTs); rather, both methodologies complement each other to build a more comprehensive understanding of cannabinoid utilization in modern medicine.