Maria Hernandez's Contact Details

Maria Hernandez's Company Details

Pro Pharma Research Organization SA de CV

Mexico City, Federal District, Mexico • 13 Employees
Pharmaceuticals

We as a CRO, offer our services with highest quality standards to meet the global compliance requirements of the Pharma industry. We are the only CROfrom Mexico in our segment that had been ISO 9001 and ISO 27001 certified. We are focused on analyzing and gathering real world data for thesolutions throughout the life cycle of medicines to know the use in real lifeand demonstrate the safety, efficiency, and effectiveness of the use ofmedicines.OUR SERVICES:• PMOS / PASS / RWD/ RWE Studies:* Phase IV study protocols, Real World Data, Real World Evidence andPharmaco-epidemiological studies.* Methodological designs for specific objectives.* Efficient execution of studies.* During post-marketing we optimize the study methodology to achieve the defined objectives, with a reasonable investment, and obtaining evidence on the safety and use of the evaluated drugs.* Clinical monitoring: to guarantee adherence to the protocol and the GCPs during the development of clinical intervention studies.*Analysis of results contextualized to the region.*Drafting and presentation of study reports.• Clinical Trails:* Design and drafting of protocols.* Submission of protocols to institutional committees (CEI, CEI, CBS) and authorities (CAS).* Execution of studies (use of drugs, patient records, PMOS, PASS, post-authorization effectiveness and satisfaction studies, etc.).* Clinical monitoring of phase II, III, IV and BE studies.• Medical and regulatory drafting/writing:• Call center / Patient support programs (PSPs)• Regulatory / Market access / Pharmaco-economic studies & Evaluation• Medical affairs / MSL - Digital• Pharmacovigilance and Technovigilance unit• Second-party audits• TrainingsWe continuously strive to be an exemplary service provider with unmatched quality, innovation, speed, accuracy and efficiency in service delivery, helping our clients to increase their potential with our constant support.