Design-Build-Operate Services
Optimize Pharmaceutical Operations with Customized Solutions for LATAM
Pro Pharma Research Organization provides comprehensive "Design-Build-Operate" services for the pharmaceutical industry in Latin America (LATAM).
Specializing in establishing and managing Medical Information, Pharmacovigilance (PV), Medical Affairs, Real-World Evidence (RWE), and Marketing Units, our solutions ensure operational efficiency and compliance with sector standards and regulations.
Service overview
Design of Medical Information Units
We assess needs to identify requirements and objectives, design a customized plan covering infrastructure, technology, and personnel, and ensure compliance with local and international regulations.
Construction of Medical Information Units
We implement advanced information systems for efficient data management, recruit and train medical information specialists, and establish Standard Operating Procedures (SOPs) for handling inquiries, documentation, and reports.
Operation of Medical Information Units
We manage daily operations to ensure accurate information dissemination, continuously update and train staff on products, regulations, and medical advancements, and monitor performance indicators to implement improvements.
Design of Pharmacovigilance (PV) Units
We assess current PV processes to identify gaps, design a robust system for safety data collection, analysis, and reporting, and establish compliance frameworks with regulatory requirements.
Construction of Pharmacovigilance (PV) Units
We install advanced PV software for signal detection and reporting, hire and train PV professionals, and develop detailed SOPs for adverse event management and risk assessment.
Operation of Pharmacovigilance (PV) Units
We oversee the collection, evaluation, and reporting of adverse events, ensure continuous monitoring and risk management of products, and maintain compliance with local and global PV regulations through audits and regular updates.
Design of Medical Affairs Units
We define the strategic role and objectives of the Medical Affairs Unit, create a framework for engagement with Key Opinion Leaders (KOLs) and scientific communication, and design protocols for clinical trials and studies that support product evidence.
Construction of Medical Affairs Units
We establish a team of Medical Science Liaisons (MSLs) and medical advisors, implement systems for managing clinical trials, medical communication, and publications, and develop SOPs for interactions with healthcare professionals and regulatory bodies.
Operation of Medical Affairs Units
We facilitate KOL interactions and support scientific discussions, manage clinical trials and observational studies to generate evidence, and ensure consistent and compliant scientific communication.
Design of Real-World Evidence (RWE) Units
We identify key data sources and define RWE objectives. We develop a comprehensive strategy for data collection, integration, and analysis, and design protocols for observational studies and patient registries.
Construction of Real-World Evidence (RWE) Units
We implement data management systems capable of handling large datasets, recruit data scientists, epidemiologists, and biostatisticians, and develop SOPs for data collection, analysis, and reporting.
Operation of Real-World Evidence (RWE) Units
We conduct RWE studies to generate insights on treatment patterns, outcomes, and value. We integrate RWE findings into clinical and commercial strategies, and maintain data quality and compliance with data protection regulations.
Design of Marketing Units
We conduct market research to understand the target audience and competitive landscape. We develop a comprehensive marketing strategy encompassing branding, positioning, and messaging, and create a multichannel marketing plan including digital, print, and in-person engagement.
Construction of Marketing Units
We establish a marketing team with pharmaceutical industry experience, develop marketing materials and digital assets, and set up marketing automation tools to manage campaigns and perform analytics.
Operation of Marketing Units
We execute marketing campaigns to increase product awareness and adoption, monitor and analyze campaign performance to optimize strategies, and ensure compliance with marketing and advertising regulations.
Pro Pharma Research Organization offers extensive experience in the LATAM pharmaceutical market, comprehensive solutions from design to operation, and a strong commitment to quality and regulatory compliance. We utilize advanced technology to optimize efficiency and provide customized solutions that drive success and improve patient outcomes.
