Clinical Research Services
Training:
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Design and delivery of tailored training courses covering all
aspects of clinical research and clinical trial regulations. Face
to face or multimedia e-learning formats, customized to sponsor
requirements.
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On-the-field coaching for new monitors
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LeadCRAs / PMs: personalized leadership programs.
Quality:
GCP audits: Domestic and International Clinical Research Trial
audits. We provide the full audit report plus a strategic plan to
address findings.
Co-Monitoring activities: co-monitoring visits for investigator
sites, vendors, study files or Investigator Site files.
SOPs development / revision: assist in developing and/or
reviewing / revising SOPs for the clinical research area in
accordance with GCP and client needs.
Inspection readiness: preparation for upcoming external audits
or regulatory agency inspections for sites and company affiliates
Guidance for responding warning letters, audit / inspection
reports.
Pharmacovigilance Services
Our company offers to satisfy the needs of the pharmaceutical companies
by providing integral Pharmacovigilance (PVG) services and risk management
solutions concerning marketed medicinal products on a challenging regulatory
framework in Latin America.
Individual Case Safety Report (ICSR) Management:
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Case information collection from any source type (e.g. spontaneous,
observational studies, etc.)
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Case processing in Jazz® (our Drug Safety Database
- web system) or in the Client's database
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Triage and coding of medical terminology (MedDRA)
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Case narrative
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Medical assessment of single cases
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Statistical reports for the Client on case processing
and reporting (on a monthly basis)
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Development and analysis of aggregate reports
Regulatory Services and Medical Writing:
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Implementation of the local PVG legislation requirements.
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Case reporting: preparation and submission of customized safety reports
to the local Health Authority (in accordance to local requirements)
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Preparation and submission of Periodic Safety Update Reports
(PSUR/PBRER) to the local Health Authorities
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Development of Risk Management Plans (RMP) / Risk Assessment
Signal Management & Risk Assessment:
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Development and implementation of Product Surveillance Plans
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Signal management and product information review
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Benefit-risk assessment and support on safety issue management
(e.g. communication to Regulatory Authorities and/or health professionals)
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Medical support for decision making in labeling update
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Development and implementation of risk minimization strategies
Post Marketing Surveillance & Patient Support programs:
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Program and e-CRF design for PVG monitoring programs (e.g.
intensive PVG programs) and observational studies (e.g.
post-authorization safety studies (PASS) and others)
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Statistical analysis, preparation and submission of the final report
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Implementation of Patient Support Programs, as per Client needs
Training activities:
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Elaboration and conduction of PVG training programs (e.g. interactive
workshop on PVG regulatory requirements)
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Basic and advanced training on PVG topics "in house"
(face-to-face or by videoconference) or through e-learning
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Training material preparation and recording
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Training plan development
Quality Management System:
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Implementation of a Local PVG and Quality System
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Preparation and update of Standard Operating Procedures,
Working Instructions, Policies and Guidelines
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Preparation and maintenance of the Pharmacovigilance System
Master File and Business Continuity Plan
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Quality Monitoring Visits - Audit preparation
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Implementation and follow up of CAPAs
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Inspection readiness/support for PV topics
Other PVG Services:
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Local scientific literature screening: systematic literature searches & review
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Medical Information (including specialized Call Center support)
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Pharmacovigilance Agreements