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Clinical Research

Clinical Research

Medical Writing

Medical Writing

Professional documentation services that guarantee the compliance of your protocols, informed consent forms, and clinical study reports with the regulatory standards. Thus, facilitating the submission to health authorities without any hassle.

Biostatistics

Biostatistics

Professional statistical help that consists of: justification of sample size, planning of randomization, and thorough statistical reporting that is resistant to the scrutiny of regulators.

Data Management

Data Management

Strong systems and protocols to maintain the integrity of the data during the entire lifecycle of your trial, from planning the initial collection to locking the database and transferring the final data.

Clinical Operations

Clinical Operations

complete management of operational tasks that includes identifying and activating sites, regulatory submissions, monitoring activities, and daily coordination of the project to ensure your trial stays on schedule.

Pharmacovigilance

Pharmacovigilance

Systems for monitoring and reporting of safety that facilitate the prompt identification, evaluation, and reporting of adverse events to both local and international authorities in compliance with their respective requirements.

Quality Assurance

Quality Assurance

Independent quality control through regular audits, qualification processes, and compliance checks, which recognize and rectify potential problems before they affect your study.

Medico-Marketing

Medico-Marketing

Commercial strategies based on evidence that convert clinical research results into medical education and marketing initiatives effectively complying with regulatory and ethical standards.

Site Management Organization (SMO)

Site Management Organization (SMO)

Dedicated site support services optimizing investigator performance through training, patient recruitment assistance, and operational coordination across multiple study locations.