Clinical Research and Real-World Evidence

Where clinical experience becomes evidence

Comprehensive clinical trial management, with local evidence for more reliable decisions in oncology.

We design, coordinate, and support clinical trials, observational studies, and real-world data/evidence (RWD/RWE) projects, pharmacovigilance, and scientific publications, with particular strength in oncology.

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Good Clinical Practice (ICH-GCP)

Compliance with applicable Ecuadorian regulations

Electronic data integrity and traceability

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20+ years

Clinical experience

The founder's oncology clinical track record, applied to project development.

Multidisciplinary team

Science, operations and quality

Methodology, data, biostatistics, pharmacovigilance, medical writing and coordinated execution.

Local CRO

Knowledge of the Ecuadorian context

Close ties with investigators, institutions and the real needs of the health system.

End-to-end model

From protocol to evidence

Support from study design through analysis, quality, and scientific communication.

Headquarters

Guayaquil, Ecuador

About Us

Who We Are

CLINVEC is an Ecuadorian Contract Research Organization that integrates clinical expertise, methodology, operations, pharmacovigilance, data management, biostatistics, quality, and medical writing.

We support the pharmaceutical industry, investigators, and healthcare institutions from identifying a need through to generating, interpreting, and communicating evidence.

Quality and compliance

Processes aligned with Good Clinical Practice (ICH-GCP) and applicable Ecuadorian regulation.
Scientific collaboration network

We work alongside investigators, institutions, and specialized centers to develop high-impact projects.
Clinical specialization

Particular strength in oncology and the capacity to develop projects in multiple therapeutic areas.

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Services

What we do for you

From protocol design to scientific publication, we cover every stage of your clinical trial or research study.

Real-World Data and Evidence

We design RWD/RWE studies that connect real clinical practice with scientifically valid evidence for decision-making.

RWDRWEEvidence

Pharmacovigilance

Adverse event assessment and reporting to ARCSA, with post-authorization studies that follow the entire drug lifecycle.

AEs/SAEsPost-authorizationARCSA

Medical Writing and Publications

Manuscript drafting and scientific communication under EQUATOR Network standards, with a focus on methodological and editorial credibility.

ManuscriptsEQUATORPublications

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Specialties

Areas of Expertise

Specialized in oncology, with the capacity to develop clinical research across multiple therapeutic areas.

Primary specialty

Oncology

Solid tumors
Onco-hematology
Biomarkers
Real-world evidence (RWD/RWE)
Clinical trials

Cardiometabolic Diseases

Cardiology
Diabetes
Obesity
Hypertension
Cardiovascular risk

Neuroscience

Neurology
Neurodegenerative diseases
Epilepsy
Movement disorders

Infectious Diseases

Vaccines
Antivirals
Antibiotics
Tropical diseases

Rare Diseases and Other Specialties

Orphan diseases
Multicenter studies
Personalized projects

Research Capabilities

Clinical Trials (Phase II–IV)
Observational Studies
Real-World Evidence (RWD/RWE)
Pharmacovigilance
Patient Registries
Biomarker Studies
Data Management and Biostatistics
Medical Writing and Scientific Publications

Is your project in a different therapeutic area? We adapt our expertise and methodology to the needs of each study.

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Investigators

Our Network of Investigators

We collaborate with investigators and specialists selected according to the therapeutic area, complexity, and requirements of each project.

Clinical Collaboration Network

We bring together investigators and specialists with clinical experience, with particular strength in oncology and the capacity to expand into other therapeutic areas.

Research Quality

We promote the involvement of teams trained in Good Clinical Practice (ICH-GCP) and compliance with applicable ethical and regulatory standards.

Evidence Generation

We drive investigator participation in clinical trials, RWD/RWE, observational projects, and scientific output.

Let's build evidence together

We collaborate with investigators, institutions, and strategic partners to develop clinical research projects and generate relevant scientific evidence.

Develop your project with CLINVEC →

How We Work

An end-to-end path, from need to publication

We support every project end to end, from identifying the need through the scientific communication of results, with a methodological, operational, and quality-driven approach.

01

Diagnosis and feasibility

We analyze the client's or investigator's need, existing evidence, available population, data sources, potential sites, resources, and project viability.

02

Methodological design

We define the research question, objectives, population, variables, endpoints, design, sample size, analysis plan, and essential documentation.

03

Activation

We coordinate the ethical, regulatory, contractual, documentary, technological, and training processes needed to start.

04

Execution and quality

We manage sites, data, follow-up, monitoring, queries, deviations, safety, and protocol compliance.

05

Analysis and interpretation

We perform statistical analysis and build tables, figures, indicators, and a joint clinical interpretation.

06

Scientific communication

We prepare reports, dossiers, presentations, posters, and manuscripts, and support the editorial process.

From the initial diagnosis to scientific publication: a structured, traceable, results-oriented path.

Quality and Compliance

Quality at every stage

Quality and regulatory compliance are the foundation of every project we run, from protocol design through delivery of results.

Quality Management System

Internal audits, master file (eTMF) management, and standard operating procedures (SOPs) that ensure traceability for every study.

Regulatory Compliance

We operate under Good Clinical Practice (ICH-GCP) and Ecuador's national AM 069-2024 regulation (MSP/ARCSA), with processes oriented toward continuous compliance at every phase of the study.

Data Integrity

Clinical databases designed under ALCOA+ principles and CDISC standards, with continuous validation of data quality.

Good Clinical Practice (ICH-GCP)AM 069-2024 MSP/ARCSACDISCData Integrity & TraceabilityEQUATOR NetworkLOPDP

Partnerships

Strategic partnerships

We build a collaboration network with healthcare institutions, investigators, specialized providers, and strategic partners to expand our capabilities and meet the needs of each project.

Specialized Alliances

Strategic support network

We bring together specialized partners in regulatory, bioanalytical, technology, and other complementary services according to the requirements of each study.

Collaboration Network

Investigators, institutions, and sponsors

We foster strategic ties to facilitate clinical research, evidence generation, and collaborative projects in Ecuador and the region.

Let's collaborate

Ready to take your research to the next level?

Our team is available to discuss how CLINVEC can support your clinical research projects in Ecuador, with regional coordination capability through strategic partnerships.

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